Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial

Not Applicable

• Conditions: Schizophrenia
• Interventions: Behavioral: Continuity of specialized care; Behavioral: Discontinuity of care, non specialised care; Behavioral: Parent groups combined with Continuity of Specialized care

• Registration Number: NCT01936220
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief Summary

Objective: to evaluate the effectiveness of specialised and sustained intervention with or without parent groups during the initial phase of schizophrenia or related disorders on relapse prevention

Methods: A three conditions randomized trial with a duration of five years

Participants: 200 consecutively referred patients aged 15-28 years with a first psychotic episode of schizophrenia or related disorder

Treatment-conditions: Specialized Treatment of early schizophrenia (ST), ST including Parent groups (ST+P) and Treatment As Usual (TAU).

Outcome-measures: cumulative relapse rates and time to first relapse after first remission. Secondary outcome measure: social functioning.

Statistical analysis: cumulative relapse rates using life-table methods. The effect of the three interventions on time to first relapse after remission will be compared using Cox regression analysing intention to treat (ITT) grouping.

Detailed Description

Evidence for optimal duration and necessary ingredients of early and sustained specialized treatment from first episode psychosis till the end of the initial phase schizophrenia is still insufficient. Randomized trials with a treatment duration of six months to two years with favorable symptomatic and psychosocial results disappeared at five year follow-up. Other studies suggest that specialized treatment should last 5 years in order to be able to prevent instead of only delaying clinical and psychosocial deteriorating.

In this study we examine both the symptomatic (relapse) and psychosocial outcome of a three armed five year randomized trial in the initial phase of schizophrenia.

Study Timeline

• Study Start: 1997-09
• Primary Completion: 2007-02
• Study First Submitted: 2013-08-23
• Status Verified: 2013-09
• Study First Submitted QC: 2013-09-05
• Last Update Submitted: 2013-09-05
• Study First Posted: 2013-09-06
• Last Update Posted: 2013-09-06
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients were eligible for the study if they: 1) met DSM-IV-Revised criteria for schizophrenia or related disorders, 2) were suffering from a first psychotic episode and 3) were living in contact with parent(s) or other relatives.

Exclusion Criteria

• Patients with drug-related psychoses were not included.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Continuity of specialized care	Continuity of specialized care	Continuity of specialized inpatient and outpatient care (relapse prevention)
Continuity of specialized care and parent groups	Continuity of specialized care	Continuity of specialized care combined with Parent groups
Continuity of specialized care and parent groups	Parent groups combined with Continuity of Specialized care	Continuity of specialized care combined with Parent groups
Treatment as usual	Discontinuity of care, non specialised care	Discontinuity of care, relapse prevention as usual

Primary Outcome Measures

Name	Time	Method
Change in Psychotic relapse	at year 1, year 3 and year 5	Participants will be followed for the duration of the 5 year outpatient treatment of the trial. During the trial the timing and number of psychotic relapses of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial.; Trained interviewers not involved in clinical treatment of patients will elicit with the LCS detailed information of symptoms, signs and treatment from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in symptomatology since the last interview. All details will be fitted in a schedule with 6 months intervals.

Secondary Outcome Measures

Name	Time	Method
Change in Social functioning	at year 1, year 3 and year 5	During the duration of the 5 year outpatient treatment of the trial social functioning of each participant will be assessed using the Life Chart Schedule (LCS) at year 1, year 3 and year 5 after the start of the trial.; Detailed information of social functioning in work, study, school and relations will be elicited from respondents (patients and/or parents) and from clinical records. Respondents will be asked to indicate any changes in functioning since the last interview.All details will be fitted in a schedule with 6 months.

Trial Locations

Locations (1)

Academic Medical Center University of Amsterdam; 🇳🇱 Amsterdam, N Holland, Netherlands