N/A
Completed N=120
Specialized Treatment Early in Psychosis (STEP)
Schizophrenia and Disorders With Psychotic Features
Source: ClinicalTrials.gov NCT00309452 ↗
Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcomePrimary: Number of Patients Hospitalized — 25; 14 participants — p=0.018
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Hospitalized |
25; 14 | 0.018 sig |
| SECONDARY Relapse |
— | — |
| SECONDARY Overall Functioning- Global Assessment of Functioning |
34.42; 36.22; 20.38; 22.22 | — |
| SECONDARY Quality of Life- Heinrich's Quality of Life Scale |
59.45; 59.87; -.80; 9.81 | — |
| SECONDARY Vocationally Engaged |
26; 44 | 0.002 sig |
| SECONDARY Treatment Satisfaction |
— | — |
| SECONDARY Adherence- in Contact With Mental Health Services |
33; 39 | — |
| SECONDARY Substance Use |
— | — |
| SECONDARY Subjects Who Committed Self-harm and Violence |
0; 0 | — |
| SECONDARY Medication (Including Metabolic) Side Effects |
— | — |
| SECONDARY Economic Measures Including Service Use, Cost of Care and Forensic Data. |
12157.46; 7625.22 | — |
Eligibility Criteria
Inclusion Criteria
- Age 16-45
- Meets DSM-IV schizophrenia spectrum psychosis or affective psychosis according to the SCID
- ≤8 weeks of received antipsychotic treatment lifetime at time of referral
- Willing to be treated in New Haven
Exclusion Criteria
- Psychosis believed due to substance use (based on the SCID)
- Unable or unwilling to give informed consent
- MR as indicated by receipt of services from Dept of Mental Retardation
Data sourced from ClinicalTrials.gov (NCT00309452). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.