Relapse Prevention in First Episode Schizophrenia: a 5 Year Trial

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Status: Unknown

Conditions: Schizophrenia

Treatments: Behavioral: Continuity of specialized care; Behavioral: Discontinuity of care, non specialised care; Behavioral: Parent groups combined with Continuity of Specialized care

Study type: Interventional

Funder types: Other

Identifiers

NCT01936220

Grant 28-1241-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 15 to 28 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 3 patient groups

Continuity of specialized care

Experimental group

Description:

Continuity of specialized inpatient and outpatient care (relapse prevention)

Treatment:

Behavioral: Continuity of specialized care

Continuity of specialized care and parent groups

Experimental group

Description:

Continuity of specialized care combined with Parent groups

Treatment:

Behavioral: Parent groups combined with Continuity of Specialized care

Behavioral: Continuity of specialized care

Treatment as usual

Active Comparator group

Description:

Discontinuity of care, relapse prevention as usual

Treatment:

Behavioral: Discontinuity of care, non specialised care