Stimulant UseSTIM-RADNCT06073340
The Longitudinal Study of Stimulant Use Disorder
An observational study of Stimulant Use and Stimulant-Related Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This research is a 5-year observational, longitudinal registry study with no treatment or medication provided as part of participation. Individuals with current or lifetime stimulant use disorder, in addition to healthy control individuals, may be eligible to participate in this study. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Stimulant Use, Stimulant-Related Disorder, Healthy
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2023to 31 Mar 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Approximately 1,000 adults who meet eligibility criteria for Stimulant Use Disorder, as confirmed by the MINI and supplement. Additionally, 500 healthy control individuals will be enrolled. Current stimulant use disorder will be supported by a urine sample positive for stimulants (such as amphetamines, methamphetamine, cocaine, 3,4-Methylenedioxymethamphetamine, or prescription stimulants).
Who may be able to join
- Be an adult between the ages of 18-85, inclusive.
- Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions.
- For participants with current/history of Stimulant Use Disorder: Subjects must meet MINI International Neuropsychiatric Inventory (MINI) criteria for current stimulant use disorder or meet MINI supplemental criterial for lifetime stimulant use disorder. For Healthy control individuals: Subjects must meet criteria for a healthy control: No history of substance use disorder or other mental illness as defined by the MINI International Neuropsychiatric Inventory (MINI).
- Be willing to provide consent and comply with all procedure instructions.
- Be willing to provide blood samples and participate in EEGs and MRIs.
Who cannot join
- For participants with stimulus use disorder cohort: Have a history of schizophrenia, schizoaffective disorders, or chronic psychotic disorders based on the MINI. For healthy control individuals: Have a history of substance use disorder or any other psychiatric disorder as defined by the MINI and supplemental questions.
- Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
- Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Longitudinal Study of Individuals With Stimulant Use Disorder: Research and Development of a Biosignature
This research is a 5-year observational, longitudinal registry study with no treatment or medication provided as part of participation. Individuals with current or lifetime stimulant use disorder, in addition to healthy control individuals, may be eligible to participate in this study. A variety of assessments and tasks including Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), blood draws, urine drug screens, and both self-report and clinician-rated assessments will be used to assess biomarkers in this population. This study has a visit schedule of four in-person visits and eight remote visits per year.
Read the detailed description
This project is a five-year observational study that will use a variety of assessments and tasks to phenotype participants with lifetime or current Stimulant Use Disorder as well as healthy control individuals. The data collection will include collecting urine samples for diagnostic tracking, socio-demographic and lifestyle factors, clinical and behavioral assessments, blood-based biomarkers, genomics, cell-based assays, EEG, and MRI to establish phenotypic biosignature subtypes over the longitudinal timeline.
- Conditions
- Stimulant Use, Stimulant-Related Disorder, Healthy
What is being measured
The primary outcome is the main question the study is designed to answer.
Stimulant Use
The primary outcome measure is maintaining a naturalistic database of stimulant use disorders using urine drug screens and self-reported use through the Timeline follow-back questionnaires.
Measured: 5 years
Secondary outcomes (10)
Demographic Differences in Stimulant Use
Based on racial, ethnic, and socioeconomic status, compare the demographic disparity of the stimulant use disorder compared to healthy controls.
Measured: 5 years
Longitudinal changes from baseline in self-reported stress assessed by Perceived Stress Scale
Participants' perceived level of stress will be assessed with the Perceived Stress Scale (PSS), a 10-item self-administered scale that is used to measure an individual's level of perceived stress in the past month. The PSS score is obtained by summing across items (responses to the four positively stated items first need to be reversed). Individual scores on the PSS can range from 0 to 40 where higher scores indicate higher levels of perceived stress.
Measured: 5 years
Longitudinal changes from baseline in symptom tracking assessed by the Concise Associated Symptom Tracking Scale (CAST-IRR)
Participants' associated mood symptoms will be assessed using a 10-item version of the Concise Associated Symptom Tracking Scale Self-Report (CAST-IRR), a self-report scale that assesses irritability. Each individual item is rated on a 5-point Likert scale with responses of "strongly disagree," "disagree," "neither agree nor disagree," "agree," and "strongly agree" corresponding to scores of 1, 2, 3, 4, and 5, respectively, and a total score of 5-50. An increased score indicates higher irritability levels.
Measured: 5 years
Longitudinal changes from baseline in quality of life assessed by the Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
The Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) is a 16-item self-administered questionnaire that captures degree of enjoyment and satisfaction experienced by an individual over the past week. Each question is rated on a 5-point scale from 1 (Very Poor) to 5 (Very Good). Scores from the individual items are added together and reported as a percentage maximum possible score.
Measured: 5 years
Longitudinal changes from baseline in productivity assessed by Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)
The Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP) Version 2.0 will be used to assess work impairment due to substance use disorder. Six items comprise the measure, with the first item asking about whether participants are currently employed/working for pay. If so, participants complete five additional items, which include how many hours from work are missed due to substance use disorder (SUD), productivity while working and ability to do regular daily activities besides work. The latter two items are scored on a scale of 0 (SUD had no effect on work) to 10 (SUD completely prevented me from working).
Measured: 5 years
Longitudinal changes from baseline in symptoms of mania assessed by the Altman Self-Rating Mania scale (ASRM).
The Altman Self-Rating Mania Scale (ASRM) is a 5-item self-administered scale designed to assess the presence and/or severity of manic symptoms. Each item on the measure is rated on a 5-point scale (i.e., 1 to 5) with response categories having different anchors depending on the item. The ASRM score ranges from 5-25 with higher scores indicating greater severity of manic symptoms. A cutoff score of 6 or higher indicates a high probability of a manic or hypomanic condition. A score of 5 or lower is less likely to be associated with significant symptoms of mania.
Measured: 5 years
Longitudinal changes from baseline sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a 19-item self-report questionnaire which assesses sleep quality and disturbances over a 1-month time interval. The 19-items are grouped into seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Each of these seven subcategories is weighted equally on a 0-3 scale, which are then combined to yield a global PSQI score with a range of 0-21. A higher PSQI score indicates more acute sleep disturbances.
Measured: 5 years
Longitudinal changes from baseline on proteomic, metabolomic, transcriptomic, and epigenomic factors assessed using fluid-based biomarkers
Comparison of Longitudinal changes in fluid-based biomarkers as measured by proteomic methods, metabolomics methods, transcriptomic methods, genomic methods, and epigenomic methods in patients with Stimulant Use Disorder versus Healthy Controls.
Measured: 5 years
Longitudinal changes from baseline Electroencephalogram (EEG) metrics
The EEG includes pre-treatment alpha and theta EEG power and source localization measures of theta activity in the rostral Anterior Cingulate Cortex, the Loudness Dependency of Auditory Evoked Potentials, and assessment of psychomotor slowing (measured during reaction time, word fluency, implicit emotion processing or regulation, and reward learning tasks), cognitive control (as measured by interference and post-error adjustments), working memory, and reward-conditioned learning.
The EEG metrics will be measured in terms of Alpha (8-13 Hz), beta (13-30 Hz), delta (0.5-4 Hz), and theta (4-7 Hz) waves and compared with baseline every 3 months for 5 years.
Measured: Baseline and every three months for five years
Longitudinal changes from baseline Magnetic Resonance Imaging (MRI) metrics
The Structural MRI measures cortical thickness. Structural MRI volume differences of the brain region will be measured and compared to the baseline every 6 months.
The Functional MRI measures resting state intracerebral connectivity. Changes in functional connectivity will be assessed from baseline to every 6 months for 5-years during enrollment period.
Pulsed Arterial Spin Labeling (PASL), a measure of regional cerebral blood flow, will be assessed through changes in the cerebral metabolic oxygen rate measure from baseline to every 6 months for 5-years during enrollment period.
Diffusion Tensor Imaging (DTI) will assess changes in the white matter connectivity measure from baseline to every 6 months for 5 years during enrollment period.
Magnetic Resonance Spectroscopy (MRS) will assess changes in the neurochemistry of glutamate and GABA from baseline to every 6 months for 5 years during enrollment period.
Measured: Baseline and every six months for five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start16 Nov 2023
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Why it stopped: Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Stimulant UseStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center
- Investigators
- Madhukar Trivedi, M.D., Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073340
- Sponsor's protocol ID
- STU-2023-0578
- Acronym
- STIM-RAD
- Status last verified
- Apr 2025
- First submitted
- 15 Sep 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ronsley C, Nolan S, Knight R, Hayashi K, Klimas J, Walley A, Wood E, Fairbairn N. Treatment of stimulant use disorder: A systematic review of reviews. PLoS One. 2020 Jun 18;15(6):e0234809. doi: 10.1371/journal.pone.0234809. eCollection 2020.
PubMed 32555667Cao KX, Ma ML, Wang CZ, Iqbal J, Si JJ, Xue YX, Yang JL. TMS-EEG: An emerging tool to study the neurophysiologic biomarkers of psychiatric disorders. Neuropharmacology. 2021 Oct 1;197:108574. doi: 10.1016/j.neuropharm.2021.108574. Epub 2021 Apr 22.
PubMed 33894219Domenici E, Wille DR, Tozzi F, Prokopenko I, Miller S, McKeown A, Brittain C, Rujescu D, Giegling I, Turck CW, Holsboer F, Bullmore ET, Middleton L, Merlo-Pich E, Alexander RC, Muglia P. Plasma protein biomarkers for depression and schizophrenia by multi analyte profiling of case-control collections. PLoS One. 2010 Feb 11;5(2):e9166. doi: 10.1371/journal.pone.0009166.
PubMed 20161799Liu MT. Pharmacotherapy treatment of stimulant use disorder. Ment Health Clin. 2021 Nov 8;11(6):347-357. doi: 10.9740/mhc.2021.11.347. eCollection 2021 Nov.
PubMed 34824959Garrison KA, Potenza MN. Neuroimaging and biomarkers in addiction treatment. Curr Psychiatry Rep. 2014 Dec;16(12):513. doi: 10.1007/s11920-014-0513-5.
PubMed 25308385Smith DF. Quest for biomarkers of treatment-resistant depression: shifting the paradigm toward risk. Front Psychiatry. 2013 Jun 18;4:57. doi: 10.3389/fpsyt.2013.00057. eCollection 2013.
PubMed 23785338Biernacka JM, Sangkuhl K, Jenkins G, Whaley RM, Barman P, Batzler A, Altman RB, Arolt V, Brockmoller J, Chen CH, Domschke K, Hall-Flavin DK, Hong CJ, Illi A, Ji Y, Kampman O, Kinoshita T, Leinonen E, Liou YJ, Mushiroda T, Nonen S, Skime MK, Wang L, Baune BT, Kato M, Liu YL, Praphanphoj V, Stingl JC, Tsai SJ, Kubo M, Klein TE, Weinshilboum R. The International SSRI Pharmacogenomics Consortium (ISPC): a genome-wide association study of antidepressant treatment response. Transl Psychiatry. 2015 Apr 21;5(4):e553. doi: 10.1038/tp.2015.47.
PubMed 25897834Roychowdhury S, Chinnaiyan AM. Translating genomics for precision cancer medicine. Annu Rev Genomics Hum Genet. 2014;15:395-415. doi: 10.1146/annurev-genom-090413-025552.
PubMed 25184532Rethorst CD, Toups MS, Greer TL, Nakonezny PA, Carmody TJ, Grannemann BD, Huebinger RM, Barber RC, Trivedi MH. Pro-inflammatory cytokines as predictors of antidepressant effects of exercise in major depressive disorder. Mol Psychiatry. 2013 Oct;18(10):1119-24. doi: 10.1038/mp.2012.125. Epub 2012 Aug 28.
PubMed 22925832Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.
PubMed 21733476Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.
PubMed 17606655Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
PubMed 12946886Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH. The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med. 1996 May;26(3):477-86. doi: 10.1017/s0033291700035558.
PubMed 8733206Rush AJ, Bernstein IH, Trivedi MH, Carmody TJ, Wisniewski S, Mundt JC, Shores-Wilson K, Biggs MM, Woo A, Nierenberg AA, Fava M. An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report. Biol Psychiatry. 2006 Mar 15;59(6):493-501. doi: 10.1016/j.biopsych.2005.08.022. Epub 2005 Sep 30.
PubMed 16199008Bernstein DP, Fink L, Handelsman L, Foote J, Lovejoy M, Wenzel K, Sapareto E, Ruggiero J. Initial reliability and validity of a new retrospective measure of child abuse and neglect. Am J Psychiatry. 1994 Aug;151(8):1132-6. doi: 10.1176/ajp.151.8.1132.
PubMed 8037246
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Longitudinal Study of Individuals With Stimulant Use Disorder: Research and Development of a Biosignature
- ClinicalTrials.gov ID
- NCT06073340
- Acronym / sponsor ID
- STIM-RAD / STU-2023-0578
- Conditions
- Stimulant Use, Stimulant-Related Disorder, Healthy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Funding
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 10 Oct 2023 (actual)
- 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.
This research is a 5-year observational, longitudinal registry study with no treatment or medication provided as part of participation. Individuals with current or lifetime stimulant use disorder, in addition to healthy control individuals, may be eligible to participate in this study. A variety of assessments and tasks including Magnetic Resonance Imaging (MRI), Electroencephalography (EEG), blood draws, urine drug screens, and both self-report and clinician-rated assessments will be used to assess biomarkers in this population. This study has a visit schedule of four in-person visits and eight remote visits per year.
Detailed description
This project is a five-year observational study that will use a variety of assessments and tasks to phenotype participants with lifetime or current Stimulant Use Disorder as well as healthy control individuals. The data collection will include collecting urine samples for diagnostic tracking, socio-demographic and lifestyle factors, clinical and behavioral assessments, blood-based biomarkers, genomics, cell-based assays, EEG, and MRI to establish phenotypic biosignature subtypes over the longitudinal timeline.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Approximately 1,000 adults who meet eligibility criteria for Stimulant Use Disorder, as confirmed by the MINI and supplement. Additionally, 500 healthy control individuals will be enrolled. Current stimulant use disorder will be supported by a urine sample positive for stimulants (such as amphetamines, methamphetamine, cocaine, 3,4-Methylenedioxymethamphetamine, or prescription stimulants).
Key inclusion criteria (5 listed)
- Be an adult between the ages of 18-85, inclusive.
- Be able to sufficiently understand, speak, and read English to provide informed consent and ask relevant questions.
- For participants with current/history of Stimulant Use Disorder: Subjects must meet MINI International Neuropsychiatric Inventory (MINI) criteria for current stimulant use disorder or meet MINI supplemental criterial for lifetime stimulant use disorder. For Healthy control individuals: Subjects must meet criteria for a healthy control: No history of substance use disorder or other mental illness as defined by the MINI International Neuropsychiatric Inventory (MINI).
- Be willing to provide consent and comply with all procedure instructions.
- Be willing to provide blood samples and participate in EEGs and MRIs.
Key exclusion criteria (3 listed)
- For participants with stimulus use disorder cohort: Have a history of schizophrenia, schizoaffective disorders, or chronic psychotic disorders based on the MINI. For healthy control individuals: Have a history of substance use disorder or any other psychiatric disorder as defined by the MINI and supplemental questions.
- Have any condition for which study participation would not be in their best interest (e.g., cognitive impairment, unstable general medical condition, intoxication, active psychosis) or that could prevent, limit, or confound the protocol-specified assessments, in the opinion of the investigator or their designee.
- Require immediate hospitalization for psychiatric disorder or suicidal risk as assessed by a licensed study clinician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Stimulant Use
Time frame: 5 years
The primary outcome measure is maintaining a naturalistic database of stimulant use disorders using urine drug screens and self-reported use through the Timeline follow-back questionnaires.
10 secondary outcomes
Demographic Differences in Stimulant Use
Time frame: 5 years
Longitudinal changes from baseline in self-reported stress assessed by Perceived Stress Scale
Time frame: 5 years
Longitudinal changes from baseline in symptom tracking assessed by the Concise Associated Symptom Tracking Scale (CAST-IRR)
Time frame: 5 years
Longitudinal changes from baseline in quality of life assessed by the Quality-of-Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Time frame: 5 years
Longitudinal changes from baseline in productivity assessed by Work Productivity and Activity Impairment-Specific Health Problem Questionnaire (WPAI-SHP)
Time frame: 5 years
Longitudinal changes from baseline in symptoms of mania assessed by the Altman Self-Rating Mania scale (ASRM).
Time frame: 5 years
Longitudinal changes from baseline sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 5 years
Longitudinal changes from baseline on proteomic, metabolomic, transcriptomic, and epigenomic factors assessed using fluid-based biomarkers
Time frame: 5 years
Longitudinal changes from baseline Electroencephalogram (EEG) metrics
Time frame: Baseline and every three months for five years
Longitudinal changes from baseline Magnetic Resonance Imaging (MRI) metrics
Time frame: Baseline and every six months for five years
Results and safety
The study was stopped early (reason given: Funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Background: PubMed 32555667Ronsley C, Nolan S, Knight R, Hayashi K, Klimas J, Walley A, Wood E, Fairbairn N. Treatment of stimulant use disorder: A systematic review of reviews. PLoS One. 2020 Jun 18;15(6):e0234809. doi: 10.1371/journal.pone.0234809. eCollection 2020.
- Background: PubMed 33894219Cao KX, Ma ML, Wang CZ, Iqbal J, Si JJ, Xue YX, Yang JL. TMS-EEG: An emerging tool to study the neurophysiologic biomarkers of psychiatric disorders. Neuropharmacology. 2021 Oct 1;197:108574. doi: 10.1016/j.neuropharm.2021.108574. Epub 2021 Apr 22.
- Background: PubMed 20161799Domenici E, Wille DR, Tozzi F, Prokopenko I, Miller S, McKeown A, Brittain C, Rujescu D, Giegling I, Turck CW, Holsboer F, Bullmore ET, Middleton L, Merlo-Pich E, Alexander RC, Muglia P. Plasma protein biomarkers for depression and schizophrenia by multi analyte profiling of case-control collections. PLoS One. 2010 Feb 11;5(2):e9166. doi: 10.1371/journal.pone.0009166.
- Background: PubMed 34824959Liu MT. Pharmacotherapy treatment of stimulant use disorder. Ment Health Clin. 2021 Nov 8;11(6):347-357. doi: 10.9740/mhc.2021.11.347. eCollection 2021 Nov.
- Background: PubMed 25308385Garrison KA, Potenza MN. Neuroimaging and biomarkers in addiction treatment. Curr Psychiatry Rep. 2014 Dec;16(12):513. doi: 10.1007/s11920-014-0513-5.
- Background: PubMed 23785338Smith DF. Quest for biomarkers of treatment-resistant depression: shifting the paradigm toward risk. Front Psychiatry. 2013 Jun 18;4:57. doi: 10.3389/fpsyt.2013.00057. eCollection 2013.
- Background: PubMed 25897834Biernacka JM, Sangkuhl K, Jenkins G, Whaley RM, Barman P, Batzler A, Altman RB, Arolt V, Brockmoller J, Chen CH, Domschke K, Hall-Flavin DK, Hong CJ, Illi A, Ji Y, Kampman O, Kinoshita T, Leinonen E, Liou YJ, Mushiroda T, Nonen S, Skime MK, Wang L, Baune BT, Kato M, Liu YL, Praphanphoj V, Stingl JC, Tsai SJ, Kubo M, Klein TE, Weinshilboum R. The International SSRI Pharmacogenomics Consortium (ISPC): a genome-wide association study of antidepressant treatment response. Transl Psychiatry. 2015 Apr 21;5(4):e553. doi: 10.1038/tp.2015.47.
- Background: PubMed 25184532Roychowdhury S, Chinnaiyan AM. Translating genomics for precision cancer medicine. Annu Rev Genomics Hum Genet. 2014;15:395-415. doi: 10.1146/annurev-genom-090413-025552.
- Background: PubMed 22925832Rethorst CD, Toups MS, Greer TL, Nakonezny PA, Carmody TJ, Grannemann BD, Huebinger RM, Barber RC, Trivedi MH. Pro-inflammatory cytokines as predictors of antidepressant effects of exercise in major depressive disorder. Mol Psychiatry. 2013 Oct;18(10):1119-24. doi: 10.1038/mp.2012.125. Epub 2012 Aug 28.
- Background: PubMed 21733476Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.
- Background: PubMed 17606655Posner K, Oquendo MA, Gould M, Stanley B, Davies M. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. 2007 Jul;164(7):1035-43. doi: 10.1176/ajp.2007.164.7.1035.
- Background: PubMed 12946886Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, Markowitz JC, Ninan PT, Kornstein S, Manber R, Thase ME, Kocsis JH, Keller MB. The 16-Item Quick Inventory of Depressive Symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003 Sep 1;54(5):573-83. doi: 10.1016/s0006-3223(02)01866-8.
- Individual participant dataSharing planned: Undecided
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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.
Madhukar Trivedi, M.D. principal investigator
Professor
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 Stimulant Use and Stimulant-Related Disorder, run by University of Texas Southwestern Medical Center 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 8 Apr 2025. 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 was stopped early (reason given: Funding). Results are not available in the source record.
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?
Stimulant Use (time frame: 5 years). 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 NCT06073340, which also lists 37 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 8 Apr 2025.