Prodrome-Based Early Intervention With Antipsychotics vs. Benzodiazepines in First-Episode Schizophrenia

Phase 4

Completed

• Conditions: Schizophrenia; Psychoses
• Interventions: Drug: antipsychotics vs. Lorazepam (Drugs)

• Registration Number: NCT00159133
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

Brief Summary

Prodrome based early intervention with an antipsychotic drug vs. benzodiazepine was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment, the other one after stepwise drug discontinuation.

Detailed Description

In case of early signs of a relapse prodrome based early intervention with an antipsychotic drug (Haloperidol, Risperidone and other) vs. benzodiazepine (Lorazepam) was applied in patients with first episode schizophrenia after one year neuroleptic maintenance treatment. Two groups of patients were followed over a period of 1 year: one further on under maintenance neuroleptic treatment (Haloperidol, Risperidone and other) , the other one after stepwise drug discontinuation.

Study Timeline

• Study Start: 2001-11
• Study First Submitted: 2005-09-07
• Study First Submitted QC: 2005-09-07
• Study First Posted: 2005-09-12
• Primary Completion: 2006-06
• Study Completion: 2006-06
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-28
• Last Update Posted: 2008-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• First-episode in schizophrenia (according ICD-10 F20)
• Age between 18 and 55
• Informed consent
• One year neuroleptic maintenance treatment

Exclusion Criteria

• Residence outside of the catchment area
• Legal reasons
• Insufficient knowledge of the german language
• Substance abuse or addiction
• Pregnancy
• Serious physical illness
• Organic brain disease
• Contraindication to neuroleptic treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	antipsychotics vs. Lorazepam (Drugs)	Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse
2	antipsychotics vs. Lorazepam (Drugs)	Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse

Primary Outcome Measures

Name	Time	Method
relapse rate	1 year

Secondary Outcome Measures

Name	Time	Method
quality of life	1 year
social and cognitive functioning	1 year
psychopathology	1 year
side-effects	1 year
drop-out	1 year

Trial Locations

Locations (1)

German Research Network on Schizophrenia, Department of Psychiatry and Psychotherapy at the Heinrich-Heine-University Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany