View Clinical Trial (Medical Research Study)
Randomized Trial of Usual Care Versus Specialized, Phase-specific Care in the Public Sector for First Episode Psychosis.
| City: |
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New Haven |
| State: |
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Connecticut |
| Zip Code: |
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06508 |
| Conditions: |
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Schizophrenia and Disorders With Psychotic Features |
| Purpose: |
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The purpose of this study is to understand the effectiveness of a specialized package of
phase-specific treatments for individuals in the midst of their first episode of psychosis.
The pharmacologic and psychosocial treatments will be delivered within a state public mental
health center.
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| Study Summary: |
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We propose to conduct a clinical trial for first episode psychosis patients not eligible for
CMHC services that will compare randomized access to care at CMHC versus the usual procedure
of referral to community providers outside CMHC. Patients randomized to access to CMHC
services will receive multifaceted, intensive, phase-specific care delivered by a
specialized clinical team. This care will include five principal components: antipsychotic
prescription, multi-family group therapy, group cognitive behavioral therapy, cognitive
remediation and individual case management including supportive, problem solving approaches
and a focus on resumption of movement towards educational and/or employment related goals.
All consenting subjects will undergo research evaluations every six months for up to five
years. Outcomes will be assessed in the domains of re-admission (primary outcome), relapse,
symptoms, overall functioning, quality of life, education and employment, treatment
satisfaction, adherence, substance use, adverse events (including self-harm) and economic
measures including service use, cost of care and forensic data.
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| Criteria: |
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Inclusion Criteria:
1. Age 16-45
2. Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the
SCID
3. ≤8 weeks of received antipsychotic treatment lifetime at time of referral
4. Willing to be treated in New Haven
Exclusion Criteria:
1. Psychosis believed due to substance use (based on the SCID)
2. Unable or unwilling to give informed consent
3. MR as indicated by receipt of services from Dept of Mental Retardation
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| NCT ID: |
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NCT00309452 |
| Primary Contact: |
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Principal Investigator
Vinod H Srihari, M.D.
Yale University School of Medicine & Connecticut Mental Health Center
Vinod Srihari, MD
Phone: (203) 974-7816
Email: vinod.srihari@yale.edu
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| Backup Contact: |
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Email: scott.woods@yale.edu
Scott Woods, M.D.
Phone: (203) 974-7300
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| Location Contact: |
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New Haven, Connecticut 06508
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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