DepressionNCT02450240
Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
An observational study of Depression and Anxiety, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
Trial summary
In this study the investigators will seek to improve our understanding of how positive and negative valence systems, cognition, and arousal/interoception are inter-related in disorders of mood, substance use, and eating behavior. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Anxiety, Eating Disorders
- What is being tested?
- standardized diagnostic assessment, self-report questionnaires and behavioral tasks
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,271 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Community Sample
Who may be able to join
- Referred or seeking treatment, as defined by answering yes to "have you sought help for problems with":
- Anxiety and/or depressive symptoms
- Problems related to substance use
- Problems related to eating behavior
- Screened positive for problems in (1) as indicated by:
- Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
Show all 11Show fewer
- Drug Abuse Screening Test (DAST-10) score > 2
- Eating Disorder Screen (SCOFF) score ≥ 2
- Have a body mass index between 17 to 38 kg/m²
- Able to provide written informed consent.
- Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.
Who cannot join
- No telephone or easy access to telephone.
- Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
- Has any of the following DSM-V disorders:
- Schizophrenia Spectrum and Other Psychotic Disorders
- Bipolar and Related Disorders
Show all 16Show fewer
- Obsessive-Compulsive and Related Disorders
- Antisocial Personality Disorder
- Moderate to severe traumatic brain injury or other neurocognitive disorder
- Active suicidal ideation with intent or plan.
- Change in the dose or prescription of a medication within the 6 weeks before enrolling in the study that could affect brain functioning
- Prescription of a medication outside of the accepted range, as determined by the best clinical practices and current research.
- Taking drugs that affect the fMRI hemodynamic response (e.g., methylphenidate, acetazolamide, excessive caffeine intake > 1000 mg/day)
- MRI contraindications
- Unwillingness or inability to complete any of the major aspects of the study protocol
- Non-correctable vision or hearing problems
Trial locations and contacts
1 site in 1 country.
United States1 site
Laureate Institute for Brain Research
Tulsa, Oklahoma, 74136
About this study
Official title: T-1000: Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
In this study the investigators will seek to improve our understanding of how positive and negative valence systems, cognition, and arousal/interoception are inter-related in disorders of mood, substance use, and eating behavior. The investigators will recruit 1000 individuals and use a wide range of assessment tools, neuroimaging measures, blood and microbiome collections and behavioral tasks to complete the baseline and follow-up study visits. Upon completion, the investigators aim to have robust and reliable dimensional measures that quantify these systems and a set of assessments that should be recommended as a clinical tool to enhance outcome prediction for the clinician and assist in determining who will likely benefit from what type of intervention.
Read the detailed description
Neuroscience has made tremendous progress in understanding the basic neural circuitry that underlies important processes such as attention, memory, and basic emotion processing. Yet, little progress has been made to utilize these insights to apply them to psychiatric populations in order to make clinically meaningful predictions. The connection between psychiatric disorders and their underlying neurobiology has been difficult to establish. The overarching theme of this study is to determine how biological and objective behavioral measures can contribute to improving assessment and treatment of psychiatric patients. The investigators will use the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) framework as a heuristic approach that integrates neuroscience and psychopathology to study the positive and negative valence systems, cognition and arousal/interoception domains. Within this framework we will study a group of treatment seeking individuals with mental health conditions to determine how dysfunctions of affect, substance use, and eating behavior organize across different levels and whether these latent factors can be used to generate clinically useful prediction.
Using self-report, behavior, physiology, neural circuit, cell, molecule, and gene unit of analysis measures, the investigators propose to enroll 1000 individuals from four different cohorts over 5 years: (1) anxiety and/or depression; (2) eating problems; (3) substance use problems; and (4) healthy controls. Each individual will undergo a multi-level assessment that consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires, (c) behavioral tasks, (d) physiological measurements, (e) structural and functional magnetic resonance imaging (fMRI) and EEG, (f) biomarker and microbiome assessments, (g) blood to derive induced pluripotent stem cells, (h) and genetic and epigenetic assessments. These individuals will be followed up for one year and will be re-assessed using a multi-domain assessment of functioning, which will include: (a) symptom severity and duration, (b) subjective well-being, (c) psychosocial function, (c) occupational function, (d) physical health, (e) utilization of mental health resources (treatment), and (f) compliance with treatment.
- Conditions
- Depression, Anxiety, Eating Disorders, Drug Use Disorders
- Being tested
- standardized diagnostic assessment, self-report questionnaires, behavioral tasks, physiological measurements, structural and functional magnetic resonance imaging and EEG
- Keywords
- Depression, Anxiety, Eating Disorders, Substance Use, Functional Magnetic Resonance Imaging, Genetics, Behavior, Mental Health
- Medical subject headings
- Depression, Anxiety Disorders, Feeding and Eating Disorders, Substance-Related Disorders, Behavior, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized diagnostic assessmentBehavioural
self-report questionnairesBehavioural
behavioral tasksBehavioural
physiological measurementsOther
structural and functional magnetic resonance imaging and EEGOther
biomarker and microbiome assessmentsOther
blood to derive induced pluripotent stem cellsOther
genetic and epigenetic assessmentsOther
| Study group | Role | What they receive |
|---|---|---|
| Depression and Anxiety Disorders | 350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8.
Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Receives: Behavioral: standardized diagnostic assessment; Behavioral: self-report questionnaires; Behavioral: behavioral tasks; Other: physiological measurements; Other: structural and functional magnetic resonance imaging and EEG; Other: biomarker and microbiome assessments; Other: blood to derive induced pluripotent stem cells; Other: genetic and epigenetic assessments | |
| Eating Disorders | 350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2.
Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Receives: Behavioral: standardized diagnostic assessment; Behavioral: self-report questionnaires; Behavioral: behavioral tasks; Other: physiological measurements; Other: structural and functional magnetic resonance imaging and EEG; Other: biomarker and microbiome assessments; Other: blood to derive induced pluripotent stem cells; Other: genetic and epigenetic assessments | |
| Substance Use Disorders | 350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score > 2.
Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Receives: Behavioral: standardized diagnostic assessment; Behavioral: self-report questionnaires; Behavioral: behavioral tasks; Other: physiological measurements; Other: structural and functional magnetic resonance imaging and EEG; Other: biomarker and microbiome assessments; Other: blood to derive induced pluripotent stem cells; Other: genetic and epigenetic assessments | |
| Healthy Controls | 150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use.
Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. Receives: Behavioral: standardized diagnostic assessment; Behavioral: self-report questionnaires; Behavioral: behavioral tasks; Other: physiological measurements; Other: structural and functional magnetic resonance imaging and EEG; Other: biomarker and microbiome assessments; Other: blood to derive induced pluripotent stem cells; Other: genetic and epigenetic assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical Diagnosis
Test the predictive effects of endophenotypes (genetic, imaging and behavioral factors) on clinical diagnosis at baseline compared to one year later using the Mini International Psychiatric Interview in patients and healthy controls
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2020
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,271 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laureate Institute for Brain Research, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oklahoma, Rutgers University, University of California, San Diego
- Responsible party
- Sponsor
- Investigators
- Martin P Paulus, M.D., Study director, Laureate Institute for Brain Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450240
- Sponsor's protocol ID
- 2014-002
- Status last verified
- Jul 2020
- First submitted
- 6 Apr 2015
- Last updated
- 7 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Sanislow CA, Pine DS, Quinn KJ, Kozak MJ, Garvey MA, Heinssen RK, Wang PS, Cuthbert BN. Developing constructs for psychopathology research: research domain criteria. J Abnorm Psychol. 2010 Nov;119(4):631-9. doi: 10.1037/a0020909.
PubMed 20939653Insel T, Cuthbert B, Garvey M, Heinssen R, Pine DS, Quinn K, Sanislow C, Wang P. Research domain criteria (RDoC): toward a new classification framework for research on mental disorders. Am J Psychiatry. 2010 Jul;167(7):748-51. doi: 10.1176/appi.ajp.2010.09091379. No abstract available.
PubMed 20595427Park H, Forthman KL, Kuplicki R, Victor TA, Yeh HW, Thompson WK, Howlett JR, Guinjoan S, Paulus MP. Polygenic risk for neuroticism is associated with less efficient control in more difficult situations. Psychiatry Res Neuroimaging. 2023 Oct;335:111716. doi: 10.1016/j.pscychresns.2023.111716. Epub 2023 Sep 14.
PubMed 37717543Forthman KL, Kuplicki R, Yeh HW, Khalsa SS, Paulus MP, Guinjoan SM. Transdiagnostic behavioral and genetic contributors to repetitive negative thinking: A machine learning approach. J Psychiatr Res. 2023 Jun;162:207-213. doi: 10.1016/j.jpsychires.2023.05.039. Epub 2023 May 5.
PubMed 37178517Sanchez SM, Tsuchiyagaito A, Kuplicki R, Park H, Postolski I, Rohan M, Paulus MP, Guinjoan SM. Repetitive Negative Thinking-Specific and -Nonspecific White Matter Tracts Engaged by Historical Psychosurgical Targets for Depression. Biol Psychiatry. 2023 Oct 15;94(8):661-671. doi: 10.1016/j.biopsych.2023.03.012. Epub 2023 Mar 23.
PubMed 36965550Park H, Sanchez SM, Kuplicki R, Tsuchiyagaito A, Khalsa SS, Paulus MP, Guinjoan SM. Attenuated interoceptive processing in individuals with major depressive disorder and high repetitive negative thinking. J Psychiatr Res. 2022 Dec;156:237-244. doi: 10.1016/j.jpsychires.2022.10.020. Epub 2022 Oct 10.
PubMed 36270063Kirlic N, Kuplicki R, Touthang J, Cohen ZP, Stewart JL; Tulsa 1000 Investigators; Paulus MP, Aupperle RL. Behavioral and neural responses during fear conditioning and extinction in a large transdiagnostic sample. Neuroimage Clin. 2022;35:103060. doi: 10.1016/j.nicl.2022.103060. Epub 2022 May 25.
PubMed 35679785Park H, Kirlic N, Kuplicki R; Tulsa 1000 Investigators; Paulus M, Guinjoan S. Neural Processing Dysfunctions During Fear Learning but Not Reward-Related Processing Characterize Depressed Individuals With High Levels of Repetitive Negative Thinking. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jul;7(7):716-724. doi: 10.1016/j.bpsc.2022.01.002. Epub 2022 Jan 20.
PubMed 35065290Burrows K, Stewart JL, Kuplicki R, Figueroa-Hall L, Spechler PA, Zheng H, Guinjoan SM; Tulsa 1000 Investigators; Savitz JB, Kent Teague T, Paulus MP. Elevated peripheral inflammation is associated with attenuated striatal reward anticipation in major depressive disorder. Brain Behav Immun. 2021 Mar;93:214-225. doi: 10.1016/j.bbi.2021.01.016. Epub 2021 Jan 26.
PubMed 33508469White EJ, Kuplicki R, Stewart JL, Kirlic N, Yeh HW; T1000 Investigators; Paulus MP, Aupperle RL. Latent variables for region of interest activation during the monetary incentive delay task. Neuroimage. 2021 Apr 15;230:117796. doi: 10.1016/j.neuroimage.2021.117796. Epub 2021 Jan 24.
PubMed 33503481Spechler PA, Stewart JL, Kuplicki R, Paulus MP; Tulsa 1000 Investigators. Parsing impulsivity in individuals with anxiety and depression who use Cannabis. Drug Alcohol Depend. 2020 Dec 1;217:108289. doi: 10.1016/j.drugalcdep.2020.108289. Epub 2020 Sep 16.
PubMed 33002704Howlett JR, Thompson WK, Paulus MP. Computational Evidence for Underweighting of Current Error and Overestimation of Future Error in Anxious Individuals. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Apr;5(4):412-419. doi: 10.1016/j.bpsc.2019.12.011. Epub 2019 Dec 24.
PubMed 32107167Howlett JR, Paulus MP. Where perception meets belief updating: Computational evidence for slower updating of visual expectations in anxious individuals. J Affect Disord. 2020 Apr 1;266:633-638. doi: 10.1016/j.jad.2020.02.012. Epub 2020 Feb 3.
PubMed 32056939Victor TA, Khalsa SS, Simmons WK, Feinstein JS, Savitz J, Aupperle RL, Yeh HW, Bodurka J, Paulus MP. Tulsa 1000: a naturalistic study protocol for multilevel assessment and outcome prediction in a large psychiatric sample. BMJ Open. 2018 Jan 24;8(1):e016620. doi: 10.1136/bmjopen-2017-016620.
PubMed 29371263
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-1000: Latent Structure of Multi-level Assessments and Predictors of Outcomes in Psychiatric Disorders
- ClinicalTrials.gov ID
- NCT02450240
- Acronym / sponsor ID
- 2014-002
- Conditions
- Depression, Anxiety, Eating Disorders, Drug Use Disorders
- Keywords
- Depression, Anxiety, Eating Disorders, Substance Use, Functional Magnetic Resonance Imaging, Genetics, Behavior, Mental Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,271 participants (actual)
- Lead sponsor
- Laureate Institute for Brain Research, Inc.University, hospital or other
- Collaborators
- University of Oklahoma, Rutgers University, University of California, San Diego
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2020 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study the investigators will seek to improve our understanding of how positive and negative valence systems, cognition, and arousal/interoception are inter-related in disorders of mood, substance use, and eating behavior. The investigators will recruit 1000 individuals and use a wide range of assessment tools, neuroimaging measures, blood and microbiome collections and behavioral tasks to complete the baseline and follow-up study visits. Upon completion, the investigators aim to have robust and reliable dimensional measures that quantify these systems and a set of assessments that should be recommended as a clinical tool to enhance outcome prediction for the clinician and assist in determining who will likely benefit from what type of intervention.
Detailed description
Neuroscience has made tremendous progress in understanding the basic neural circuitry that underlies important processes such as attention, memory, and basic emotion processing. Yet, little progress has been made to utilize these insights to apply them to psychiatric populations in order to make clinically meaningful predictions. The connection between psychiatric disorders and their underlying neurobiology has been difficult to establish. The overarching theme of this study is to determine how biological and objective behavioral measures can contribute to improving assessment and treatment of psychiatric patients. The investigators will use the National Institute of Mental Health (NIMH) Research Domain Criteria (RDoC) framework as a heuristic approach that integrates neuroscience and psychopathology to study the positive and negative valence systems, cognition and arousal/interoception domains. Within this framework we will study a group of treatment seeking individuals with mental health conditions to determine how dysfunctions of affect, substance use, and eating behavior organize across different levels and whether these latent factors can be used to generate clinically useful prediction.
Using self-report, behavior, physiology, neural circuit, cell, molecule, and gene unit of analysis measures, the investigators propose to enroll 1000 individuals from four different cohorts over 5 years: (1) anxiety and/or depression; (2) eating problems; (3) substance use problems; and (4) healthy controls. Each individual will undergo a multi-level assessment that consists of (a) a standardized diagnostic assessment, (b) self-report questionnaires, (c) behavioral tasks, (d) physiological measurements, (e) structural and functional magnetic resonance imaging (fMRI) and EEG, (f) biomarker and microbiome assessments, (g) blood to derive induced pluripotent stem cells, (h) and genetic and epigenetic assessments. These individuals will be followed up for one year and will be re-assessed using a multi-domain assessment of functioning, which will include: (a) symptom severity and duration, (b) subjective well-being, (c) psychosocial function, (c) occupational function, (d) physical health, (e) utilization of mental health resources (treatment), and (f) compliance with treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Depression and Anxiety Disorders | – | Behavioral: standardized diagnostic assessment, Behavioral: self-report questionnaires, Behavioral: behavioral tasks, Other: physiological measurements, Other: structural and functional magnetic resonance imaging and EEG, Other: biomarker and microbiome assessments, Other: blood to derive induced pluripotent stem cells, Other: genetic and epigenetic assessments350 subjects who screen positive for anxiety or depressive symptoms on the Patient Health Questionnaire (PHQ-9) ≥ 10 and/or Overall Anxiety Severity and Impairment Scale (OASIS) ≥ 8. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. |
| Eating Disorders | – | Behavioral: standardized diagnostic assessment, Behavioral: self-report questionnaires, Behavioral: behavioral tasks, Other: physiological measurements, Other: structural and functional magnetic resonance imaging and EEG, Other: biomarker and microbiome assessments, Other: blood to derive induced pluripotent stem cells, Other: genetic and epigenetic assessments350 subjects who screen positive for problems related to eating behavior on the Eating Disorder Screen (SCOFF), score ≥ 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. |
| Substance Use Disorders | – | Behavioral: standardized diagnostic assessment, Behavioral: self-report questionnaires, Behavioral: behavioral tasks, Other: physiological measurements, Other: structural and functional magnetic resonance imaging and EEG, Other: biomarker and microbiome assessments, Other: blood to derive induced pluripotent stem cells, Other: genetic and epigenetic assessments350 subjects who screen positive for problems related to substance use on the Drug Abuse Screening Test (DAST-10), score > 2. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. |
| Healthy Controls | – | Behavioral: standardized diagnostic assessment, Behavioral: self-report questionnaires, Behavioral: behavioral tasks, Other: physiological measurements, Other: structural and functional magnetic resonance imaging and EEG, Other: biomarker and microbiome assessments, Other: blood to derive induced pluripotent stem cells, Other: genetic and epigenetic assessments150 subjects who do not screen positive for anxiety and depression symptoms or problems related to eating behavior and/or substance use. Interventions: (1) standardized diagnostic assessment, (2) self-report questionnaires, (3) behavioral tasks, (4) physiological measurements, 5) structural and functional magnetic resonance imaging and EEG, (6) biomarker and microbiome assessments, (h) blood to derive induced pluripotent stem cells, (8) and genetic and epigenetic assessments. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Community Sample
Key inclusion criteria (11 listed)
- Referred or seeking treatment, as defined by answering yes to "have you sought help for problems with":
- Screened positive for problems in (1) as indicated by:
- Have a body mass index between 17 to 38 kg/m²
- Able to provide written informed consent.
- Have sufficient proficiency in English language to understand and complete interviews, questionnaires, and all other study procedures.
Key exclusion criteria (16 listed)
- No telephone or easy access to telephone.
- Has a history of unstable liver or renal insufficiency; glaucoma; significant and unstable cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, or metabolic disturbance; or any other condition that, in the opinion of the investigator, would make participation not be in the best interest (e.g., compromise the well-being) of the subject or that could prevent, limit, or confound the protocol-specified assessments.
- A positive test for drugs of abuse, including alcohol (breath test), cocaine, marijuana, opiates, amphetamines, methamphetamines, phencyclidine, benzodiazepines, barbiturates, methadone, and oxycodone.
- Has any of the following DSM-V disorders:
- Moderate to severe traumatic brain injury or other neurocognitive disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized diagnostic assessment | Behavioural | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| self-report questionnaires | Behavioural | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| behavioral tasks | Behavioural | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| physiological measurements | Other | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| structural and functional magnetic resonance imaging and EEG | Other | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| biomarker and microbiome assessments | Other | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| blood to derive induced pluripotent stem cells | Other | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
| genetic and epigenetic assessments | Other | Depression and Anxiety Disorders, Eating Disorders, Healthy Controls, Substance Use Disorders |
Primary outcome
Change from Baseline in Clinical Diagnosis
Time frame: Baseline and 1 year
Test the predictive effects of endophenotypes (genetic, imaging and behavioral factors) on clinical diagnosis at baseline compared to one year later using the Mini International Psychiatric Interview in patients and healthy controls
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Background: PubMed 20939653Sanislow CA, Pine DS, Quinn KJ, Kozak MJ, Garvey MA, Heinssen RK, Wang PS, Cuthbert BN. Developing constructs for psychopathology research: research domain criteria. J Abnorm Psychol. 2010 Nov;119(4):631-9. doi: 10.1037/a0020909.
- Background: PubMed 20595427Insel T, Cuthbert B, Garvey M, Heinssen R, Pine DS, Quinn K, Sanislow C, Wang P. Research domain criteria (RDoC): toward a new classification framework for research on mental disorders. Am J Psychiatry. 2010 Jul;167(7):748-51. doi: 10.1176/appi.ajp.2010.09091379. No abstract available.
- Derived from this study: PubMed 37717543Park H, Forthman KL, Kuplicki R, Victor TA, Yeh HW, Thompson WK, Howlett JR, Guinjoan S, Paulus MP. Polygenic risk for neuroticism is associated with less efficient control in more difficult situations. Psychiatry Res Neuroimaging. 2023 Oct;335:111716. doi: 10.1016/j.pscychresns.2023.111716. Epub 2023 Sep 14.
- Derived from this study: PubMed 37178517Forthman KL, Kuplicki R, Yeh HW, Khalsa SS, Paulus MP, Guinjoan SM. Transdiagnostic behavioral and genetic contributors to repetitive negative thinking: A machine learning approach. J Psychiatr Res. 2023 Jun;162:207-213. doi: 10.1016/j.jpsychires.2023.05.039. Epub 2023 May 5.
- Derived from this study: PubMed 36965550Sanchez SM, Tsuchiyagaito A, Kuplicki R, Park H, Postolski I, Rohan M, Paulus MP, Guinjoan SM. Repetitive Negative Thinking-Specific and -Nonspecific White Matter Tracts Engaged by Historical Psychosurgical Targets for Depression. Biol Psychiatry. 2023 Oct 15;94(8):661-671. doi: 10.1016/j.biopsych.2023.03.012. Epub 2023 Mar 23.
- Derived from this study: PubMed 36270063Park H, Sanchez SM, Kuplicki R, Tsuchiyagaito A, Khalsa SS, Paulus MP, Guinjoan SM. Attenuated interoceptive processing in individuals with major depressive disorder and high repetitive negative thinking. J Psychiatr Res. 2022 Dec;156:237-244. doi: 10.1016/j.jpsychires.2022.10.020. Epub 2022 Oct 10.
- Derived from this study: PubMed 35679785Kirlic N, Kuplicki R, Touthang J, Cohen ZP, Stewart JL; Tulsa 1000 Investigators; Paulus MP, Aupperle RL. Behavioral and neural responses during fear conditioning and extinction in a large transdiagnostic sample. Neuroimage Clin. 2022;35:103060. doi: 10.1016/j.nicl.2022.103060. Epub 2022 May 25.
- Derived from this study: PubMed 35065290Park H, Kirlic N, Kuplicki R; Tulsa 1000 Investigators; Paulus M, Guinjoan S. Neural Processing Dysfunctions During Fear Learning but Not Reward-Related Processing Characterize Depressed Individuals With High Levels of Repetitive Negative Thinking. Biol Psychiatry Cogn Neurosci Neuroimaging. 2022 Jul;7(7):716-724. doi: 10.1016/j.bpsc.2022.01.002. Epub 2022 Jan 20.
- Derived from this study: PubMed 33508469Burrows K, Stewart JL, Kuplicki R, Figueroa-Hall L, Spechler PA, Zheng H, Guinjoan SM; Tulsa 1000 Investigators; Savitz JB, Kent Teague T, Paulus MP. Elevated peripheral inflammation is associated with attenuated striatal reward anticipation in major depressive disorder. Brain Behav Immun. 2021 Mar;93:214-225. doi: 10.1016/j.bbi.2021.01.016. Epub 2021 Jan 26.
- Derived from this study: PubMed 33503481White EJ, Kuplicki R, Stewart JL, Kirlic N, Yeh HW; T1000 Investigators; Paulus MP, Aupperle RL. Latent variables for region of interest activation during the monetary incentive delay task. Neuroimage. 2021 Apr 15;230:117796. doi: 10.1016/j.neuroimage.2021.117796. Epub 2021 Jan 24.
- Derived from this study: PubMed 33002704Spechler PA, Stewart JL, Kuplicki R, Paulus MP; Tulsa 1000 Investigators. Parsing impulsivity in individuals with anxiety and depression who use Cannabis. Drug Alcohol Depend. 2020 Dec 1;217:108289. doi: 10.1016/j.drugalcdep.2020.108289. Epub 2020 Sep 16.
- Derived from this study: PubMed 32107167Howlett JR, Thompson WK, Paulus MP. Computational Evidence for Underweighting of Current Error and Overestimation of Future Error in Anxious Individuals. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Apr;5(4):412-419. doi: 10.1016/j.bpsc.2019.12.011. Epub 2019 Dec 24.
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Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin P Paulus, M.D. study director
Laureate Institute for Brain Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Laureate Institute for Brain Research, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Clinical Diagnosis (time frame: Baseline and 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02450240, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020.