PsychosisNCT02069925
STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
A study testing Early Detection (ED) and Usual Detection in people with Psychosis and Schizophrenia, run by Yale University at 2 sites in United States.
Trial summary
The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian approach (TIPS) to early detection substantially reduce the duration of untreated psychosis (DUP) and improve outcomes beyond an established first-episode service (FES)? The primary aim of this study is: 1. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Psychosis, Schizophrenia
- What is being tested?
- Early Detection (ED) and Usual Detection
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 285 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2014to 18 Aug 2020
- Phase
- Interventional
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 16 to 35 years old,
- Within first 3 years of psychosis onset (per pre-defined SOS threshold criteria)
- Willing travel to local First Episode Service (STEP, New Haven or PREP, Boston) for treatment;
- Must live in target catchment towns for New Haven site (New Haven, East Haven, West Haven, North Haven, Hamden, Bethany, Orange, Woodbridge, Milford, and Branford) and Boston site (anywhere in Commonwealth of MA)
Who cannot join
- Established diagnosis of affective psychotic illness (Bipolar disorder or MDD with psychotic features) or psychosis secondary to substance use or a medical illness
- Unable to communicate in English
- IQ<70 or eligible for DDS (Department of Developmental Services) care
- legally mandated to enter treatment or otherwise unable to give free, informed consent
- Unable to reliably determine DUP
- Unstable medical illness
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts Mental Health Center
Boston, Massachusetts, 02115
Yale University
New Haven, Connecticut, 06520-8234
About this study
The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian approach (TIPS) to early detection substantially reduce the duration of untreated psychosis (DUP) and improve outcomes beyond an established first-episode service (FES)?
The primary aim of this study is:
- To determine whether an early detection intervention can reduce DUP in the US, as compared to usual detection. Early detection (ED) will be implemented in one US community (New Haven, CT), and usual detection efforts will continue in another (Boston, MA). DUP will be measured at admission to the corresponding first-episode services (STEP \& PREP) in each community, over one year before and throughout ED implementation. The investigators hypothesize that DUP will be reduced significantly in the early detection site compared to the usual detection site;
- A secondary aim is to determine whether DUP reduction can augment the outcomes of established FES on outcomes in the U.S. The investigators will measure symptoms, functioning and engagement with treatment at entry and over 1 year at each site. The investigators hypothesize that shorter DUP at one FES (STEP) will predict reduced distress and illness severity at entry and better early outcomes at STEP compared to PREP.
Read the detailed description
Early detection, or reducing the duration of untreated psychosis (DUP) can substantially ameliorate the distress and disability caused by psychotic illnesses. The TIPS project in Scandinavia used a combination of public and targeted education campaigns coupled with rapid availability of comprehensive services to improve the identification, referral and early treatment of psychotic illness. By targeting the dual 'bottlenecks' of inadequate mental health literacy and delayed access to effective treatment, TIPS significantly reduced DUP2 and experimentally demonstrated improved clinical presentations and outcomes.
Effective service models for new onset psychosis exist in the U.S. Multi-element specialty 'first-episode' services (FES), highlighted in this FOA, provide care that is adapted to the specific needs of younger patients and their families and can improve symptoms and functional outcomes during the critical early phase of psychotic illnesses. The NIH-funded Specialized Treatment in Early Psychosis (STEP, New Haven) project, included the first U.S.-based randomized controlled trial to establish the feasibility and effectiveness of a public-sector approach to FES.5 The Prevention and Recovery in Early Psychosis (PREP, Boston) clinic has advanced a similar model of care within an analogous public-academic collaboration.
What is required, as the next logical step, is a test of the effectiveness of TIPS' powerful approach to early detection in a policy-relevant U.S. setting, where relatively fragmented pathways to care raise both the challenges and potential public health impact of early detection. The expertise within the investigators investigative team in the design of early detection and the presence of 2 similar, effective, geographically separated and collaborative FES programs (STEP and PREP) presents an excellent opportunity to conduct such a test and thereby advance secondary prevention for psychotic illnesses in the U.S.
- Conditions
- Psychosis, Schizophrenia
- Being tested
- Early Detection (ED), Usual Detection
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Detection (ED)Behavioural
This intervention consists of educational campaigns directed at patients \& families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis
Usual DetectionBehavioural
This intervention will provide equivalent best practice care without the benefit of an early detection campaign
| Study group | Role | What they receive |
|---|---|---|
| Early Detection (ED) | Experimental | This intervention consists of educational campaigns directed at patients \& families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis Receives: Behavioral: Early Detection (ED); Behavioral: Usual Detection |
| Usual Detection | Active comparator | This intervention will provide equivalent best practice care without the benefit of an early detection campaign Receives: Behavioral: Usual Detection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Untreated Psychosis (DUP)
Time from onset of psychosis to first antipsychotic (DUP-Demand); Time from first antipsychotic to enrollment in STEP/PREP (DUP-Supply); Time from onset of psychosis to enrollment in STEP/PREP (DUP-Total)
Measured: One year before, during campaign and one year after end of campaign
Secondary outcomes (3)
Levels of social and occupational functioning
A trained assessor will administer the positive and negative syndrome scale (PANSS) scale to every subject for levels of social and occupational functioning. The PANSS is a medical scale used for measuring symptom severity of participants with schizophrenia. The PANSS rating form contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale. The total score is the sum of all scales with a minimum score of 30 and a maximum score of 210.
Measured: 1 year after enrollment in STEP/PREP
Change in levels of social and occupational functioning- social
The Global Functioning: Social scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
Measured: 6 months and 12 months
Change in levels of social and occupational functioning- roles
The Global Functioning: Role scale will be used, with symptoms rated 1 (most impaired) to 10 (superior functioning).
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study start1 Feb 2014
- Primary completion27 Feb 2020
- Study completion18 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Vinod Srihari, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069925
- Sponsor's protocol ID
- 1310012846
- Other IDs
- 1R01MH103831-01
- Status last verified
- Apr 2022
- First submitted
- 20 Feb 2014
- Last updated
- 21 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Annamalai A, Palmese LB, Chwastiak LA, Srihari VH, Tek C. High rates of obstructive sleep apnea symptoms among patients with schizophrenia. Psychosomatics. 2015 Jan-Feb;56(1):59-66. doi: 10.1016/j.psym.2014.02.009. Epub 2014 Mar 2.
PubMed 25023923Tek C, Palmese LB, Krystal AD, Srihari VH, DeGeorge PC, Reutenauer EL, Guloksuz S. The impact of eszopiclone on sleep and cognition in patients with schizophrenia and insomnia: a double-blind, randomized, placebo-controlled trial. Schizophr Res. 2014 Dec;160(1-3):180-5. doi: 10.1016/j.schres.2014.10.002. Epub 2014 Oct 29.
PubMed 25454802Tek C, Kucukgoncu S, Guloksuz S, Woods SW, Srihari VH, Annamalai A. Antipsychotic-induced weight gain in first-episode psychosis patients: a meta-analysis of differential effects of antipsychotic medications. Early Interv Psychiatry. 2016 Jun;10(3):193-202. doi: 10.1111/eip.12251. Epub 2015 May 12.
PubMed 25962699Kline ER, DeTore NR, Keefe K, Seidman LJ, Srihari VH, Keshavan MS, Guyer M. Development and validation of the client engagement and service use scale: A pilot study. Schizophr Res. 2018 Nov;201:343-346. doi: 10.1016/j.schres.2018.05.006.
PubMed 29764759Kline E, Thomas L. Cultural factors in first episode psychosis treatment engagement. Schizophr Res. 2018 May;195:74-75. doi: 10.1016/j.schres.2017.08.035. Epub 2017 Aug 30.
PubMed 28864280van Schalkwyk GI, Davidson L, Srihari V. Too Late and Too Little: Narratives of Treatment Disconnect in Early Psychosis. Psychiatr Q. 2015 Dec;86(4):521-32. doi: 10.1007/s11126-015-9348-4.
PubMed 25663602Steiner JL, Anez-Nava L, Baranoski M, Cole R, Davidson L, Delphin-Rittmon M, Dike C, DiLeo PJ, Duman RS, Kirk T Jr, Krystal J, Malison RT, Rohrbaugh RM, Sernyak MJ, Srihari V, Styron T, Tebes JK, Woods S, Zonana H, Jacobs SC. The Connecticut Mental Health Center: Celebrating 50 Years of a Successful Partnership Between the State and Yale University. Psychiatr Serv. 2016 Dec 1;67(12):1286-1289. doi: 10.1176/appi.ps.201600373. Epub 2016 Oct 3.
PubMed 27691379Foss-Feig JH, Adkinson BD, Ji JL, Yang G, Srihari VH, McPartland JC, Krystal JH, Murray JD, Anticevic A. Searching for Cross-Diagnostic Convergence: Neural Mechanisms Governing Excitation and Inhibition Balance in Schizophrenia and Autism Spectrum Disorders. Biol Psychiatry. 2017 May 15;81(10):848-861. doi: 10.1016/j.biopsych.2017.03.005. Epub 2017 Mar 14.
PubMed 28434615Dixon LB, Goldman HH, Srihari VH, Kane JM. Transforming the Treatment of Schizophrenia in the United States: The RAISE Initiative. Annu Rev Clin Psychol. 2018 May 7;14:237-258. doi: 10.1146/annurev-clinpsy-050817-084934. Epub 2018 Jan 12.
PubMed 29328779Starc M, Murray JD, Santamauro N, Savic A, Diehl C, Cho YT, Srihari V, Morgan PT, Krystal JH, Wang XJ, Repovs G, Anticevic A. Schizophrenia is associated with a pattern of spatial working memory deficits consistent with cortical disinhibition. Schizophr Res. 2017 Mar;181:107-116. doi: 10.1016/j.schres.2016.10.011. Epub 2016 Oct 10.
PubMed 27745755Breitborde NJ, Kleinlein P, Srihari VH. Causality Orientations among Individuals with First-Episode Psychosis. Psychosis. 2014 Jun 1;6(2):177-180. doi: 10.1080/17522439.2012.762801.
PubMed 24976861Hay RA, Roach BJ, Srihari VH, Woods SW, Ford JM, Mathalon DH. Equivalent mismatch negativity deficits across deviant types in early illness schizophrenia-spectrum patients. Biol Psychol. 2015 Feb;105:130-7. doi: 10.1016/j.biopsycho.2015.01.004. Epub 2015 Jan 17.
PubMed 25603283Guloksuz S, Li F, Tek C, Woods SW, McGlashan TH, Friis S, Srihari VH. Analyzing the Duration of Untreated Psychosis: Quantile Regression. JAMA Psychiatry. 2016 Oct 1;73(10):1094-1095. doi: 10.1001/jamapsychiatry.2016.2013. No abstract available.
PubMed 27580422Wasser T, Pollard J, Fisk D, Srihari V. First-Episode Psychosis and the Criminal Justice System: Using a Sequential Intercept Framework to Highlight Risks and Opportunities. Psychiatr Serv. 2017 Oct 1;68(10):994-996. doi: 10.1176/appi.ps.201700313. Epub 2017 Sep 1.
PubMed 28859587Perez VB, Woods SW, Roach BJ, Ford JM, McGlashan TH, Srihari VH, Mathalon DH. Automatic auditory processing deficits in schizophrenia and clinical high-risk patients: forecasting psychosis risk with mismatch negativity. Biol Psychiatry. 2014 Mar 15;75(6):459-69. doi: 10.1016/j.biopsych.2013.07.038. Epub 2013 Sep 16.
PubMed 24050720
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STEP-ED: Reducing Duration of Untreated Psychosis and Its Impact in the U.S.
- ClinicalTrials.gov ID
- NCT02069925
- Acronym / sponsor ID
- 1310012846
- Conditions
- Psychosis, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Harvard University, National Institute of Mental Health (NIMH)
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 18 Aug 2020 (actual)
- First posted
- 24 Feb 2014 (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.
The guiding questions for this study are: can a U.S. adaptation of a successful Scandinavian approach (TIPS) to early detection substantially reduce the duration of untreated psychosis (DUP) and improve outcomes beyond an established first-episode service (FES)?
The primary aim of this study is:
- To determine whether an early detection intervention can reduce DUP in the US, as compared to usual detection. Early detection (ED) will be implemented in one US community (New Haven, CT), and usual detection efforts will continue in another (Boston, MA). DUP will be measured at admission to the corresponding first-episode services (STEP \& PREP) in each community, over one year before and throughout ED implementation. The investigators hypothesize that DUP will be reduced significantly in the early detection site compared to the usual detection site;
- A secondary aim is to determine whether DUP reduction can augment the outcomes of established FES on outcomes in the U.S. The investigators will measure symptoms, functioning and engagement with treatment at entry and over 1 year at each site. The investigators hypothesize that shorter DUP at one FES (STEP) will predict reduced distress and illness severity at entry and better early outcomes at STEP compared to PREP.
Detailed description
Early detection, or reducing the duration of untreated psychosis (DUP) can substantially ameliorate the distress and disability caused by psychotic illnesses. The TIPS project in Scandinavia used a combination of public and targeted education campaigns coupled with rapid availability of comprehensive services to improve the identification, referral and early treatment of psychotic illness. By targeting the dual 'bottlenecks' of inadequate mental health literacy and delayed access to effective treatment, TIPS significantly reduced DUP2 and experimentally demonstrated improved clinical presentations and outcomes.
Effective service models for new onset psychosis exist in the U.S. Multi-element specialty 'first-episode' services (FES), highlighted in this FOA, provide care that is adapted to the specific needs of younger patients and their families and can improve symptoms and functional outcomes during the critical early phase of psychotic illnesses. The NIH-funded Specialized Treatment in Early Psychosis (STEP, New Haven) project, included the first U.S.-based randomized controlled trial to establish the feasibility and effectiveness of a public-sector approach to FES.5 The Prevention and Recovery in Early Psychosis (PREP, Boston) clinic has advanced a similar model of care within an analogous public-academic collaboration.
What is required, as the next logical step, is a test of the effectiveness of TIPS' powerful approach to early detection in a policy-relevant U.S. setting, where relatively fragmented pathways to care raise both the challenges and potential public health impact of early detection. The expertise within the investigators investigative team in the design of early detection and the presence of 2 similar, effective, geographically separated and collaborative FES programs (STEP and PREP) presents an excellent opportunity to conduct such a test and thereby advance secondary prevention for psychotic illnesses in the U.S.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Detection (ED) | Experimental | Behavioral: Early Detection (ED), Behavioral: Usual DetectionThis intervention consists of educational campaigns directed at patients \& families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis |
| Usual Detection | Active comparator | Behavioral: Usual DetectionThis intervention will provide equivalent best practice care without the benefit of an early detection campaign |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 16 to 35 years old,
- Within first 3 years of psychosis onset (per pre-defined SOS threshold criteria)
- Willing travel to local First Episode Service (STEP, New Haven or PREP, Boston) for treatment;
- Must live in target catchment towns for New Haven site (New Haven, East Haven, West Haven, North Haven, Hamden, Bethany, Orange, Woodbridge, Milford, and Branford) and Boston site (anywhere in Commonwealth of MA)
Key exclusion criteria (6 listed)
- Established diagnosis of affective psychotic illness (Bipolar disorder or MDD with psychotic features) or psychosis secondary to substance use or a medical illness
- Unable to communicate in English
- IQ<70 or eligible for DDS (Department of Developmental Services) care
- legally mandated to enter treatment or otherwise unable to give free, informed consent
- Unable to reliably determine DUP
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 |
|---|---|---|
| Early Detection (ED)This intervention consists of educational campaigns directed at patients \& families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis | Behavioural | Early Detection (ED) |
| Usual DetectionThis intervention will provide equivalent best practice care without the benefit of an early detection campaign | Behavioural | Early Detection (ED), Usual Detection |
Primary outcome
Duration of Untreated Psychosis (DUP)
Time frame: One year before, during campaign and one year after end of campaign
Time from onset of psychosis to first antipsychotic (DUP-Demand); Time from first antipsychotic to enrollment in STEP/PREP (DUP-Supply); Time from onset of psychosis to enrollment in STEP/PREP (DUP-Total)
3 secondary outcomes
Levels of social and occupational functioning
Time frame: 1 year after enrollment in STEP/PREP
Change in levels of social and occupational functioning- social
Time frame: 6 months and 12 months
Change in levels of social and occupational functioning- roles
Time frame: 6 months and 12 months
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 21 Apr 2022.
- Background: PubMed 25023923Annamalai A, Palmese LB, Chwastiak LA, Srihari VH, Tek C. High rates of obstructive sleep apnea symptoms among patients with schizophrenia. Psychosomatics. 2015 Jan-Feb;56(1):59-66. doi: 10.1016/j.psym.2014.02.009. Epub 2014 Mar 2.
- Background: PubMed 25454802Tek C, Palmese LB, Krystal AD, Srihari VH, DeGeorge PC, Reutenauer EL, Guloksuz S. The impact of eszopiclone on sleep and cognition in patients with schizophrenia and insomnia: a double-blind, randomized, placebo-controlled trial. Schizophr Res. 2014 Dec;160(1-3):180-5. doi: 10.1016/j.schres.2014.10.002. Epub 2014 Oct 29.
- Background: PubMed 25962699Tek C, Kucukgoncu S, Guloksuz S, Woods SW, Srihari VH, Annamalai A. Antipsychotic-induced weight gain in first-episode psychosis patients: a meta-analysis of differential effects of antipsychotic medications. Early Interv Psychiatry. 2016 Jun;10(3):193-202. doi: 10.1111/eip.12251. Epub 2015 May 12.
- Background: PubMed 29764759Kline ER, DeTore NR, Keefe K, Seidman LJ, Srihari VH, Keshavan MS, Guyer M. Development and validation of the client engagement and service use scale: A pilot study. Schizophr Res. 2018 Nov;201:343-346. doi: 10.1016/j.schres.2018.05.006.
- Background: PubMed 28864280Kline E, Thomas L. Cultural factors in first episode psychosis treatment engagement. Schizophr Res. 2018 May;195:74-75. doi: 10.1016/j.schres.2017.08.035. Epub 2017 Aug 30.
- Background: PubMed 25663602van Schalkwyk GI, Davidson L, Srihari V. Too Late and Too Little: Narratives of Treatment Disconnect in Early Psychosis. Psychiatr Q. 2015 Dec;86(4):521-32. doi: 10.1007/s11126-015-9348-4.
- Background: PubMed 27691379Steiner JL, Anez-Nava L, Baranoski M, Cole R, Davidson L, Delphin-Rittmon M, Dike C, DiLeo PJ, Duman RS, Kirk T Jr, Krystal J, Malison RT, Rohrbaugh RM, Sernyak MJ, Srihari V, Styron T, Tebes JK, Woods S, Zonana H, Jacobs SC. The Connecticut Mental Health Center: Celebrating 50 Years of a Successful Partnership Between the State and Yale University. Psychiatr Serv. 2016 Dec 1;67(12):1286-1289. doi: 10.1176/appi.ps.201600373. Epub 2016 Oct 3.
- Background: PubMed 28434615Foss-Feig JH, Adkinson BD, Ji JL, Yang G, Srihari VH, McPartland JC, Krystal JH, Murray JD, Anticevic A. Searching for Cross-Diagnostic Convergence: Neural Mechanisms Governing Excitation and Inhibition Balance in Schizophrenia and Autism Spectrum Disorders. Biol Psychiatry. 2017 May 15;81(10):848-861. doi: 10.1016/j.biopsych.2017.03.005. Epub 2017 Mar 14.
- Background: PubMed 29328779Dixon LB, Goldman HH, Srihari VH, Kane JM. Transforming the Treatment of Schizophrenia in the United States: The RAISE Initiative. Annu Rev Clin Psychol. 2018 May 7;14:237-258. doi: 10.1146/annurev-clinpsy-050817-084934. Epub 2018 Jan 12.
- Background: PubMed 27745755Starc M, Murray JD, Santamauro N, Savic A, Diehl C, Cho YT, Srihari V, Morgan PT, Krystal JH, Wang XJ, Repovs G, Anticevic A. Schizophrenia is associated with a pattern of spatial working memory deficits consistent with cortical disinhibition. Schizophr Res. 2017 Mar;181:107-116. doi: 10.1016/j.schres.2016.10.011. Epub 2016 Oct 10.
- Background: PubMed 24976861Breitborde NJ, Kleinlein P, Srihari VH. Causality Orientations among Individuals with First-Episode Psychosis. Psychosis. 2014 Jun 1;6(2):177-180. doi: 10.1080/17522439.2012.762801.
- Background: PubMed 25603283Hay RA, Roach BJ, Srihari VH, Woods SW, Ford JM, Mathalon DH. Equivalent mismatch negativity deficits across deviant types in early illness schizophrenia-spectrum patients. Biol Psychol. 2015 Feb;105:130-7. doi: 10.1016/j.biopsycho.2015.01.004. Epub 2015 Jan 17.
- Individual participant dataSharing planned: No
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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.
Vinod Srihari, MD principal investigator
Yale University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Detection (ED) and Usual Detection in people with Psychosis and Schizophrenia, run by Yale University at 2 sites 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 4 inclusion and 6 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 21 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Duration of Untreated Psychosis (DUP) (time frame: One year before, during campaign and one year after end of campaign). 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 NCT02069925, which also lists 21 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 21 Apr 2022.