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

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 4

Conditions: Schizophrenia; Psychoses

Treatments: Drug: antipsychotics vs. Lorazepam (Drugs)

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00159133

01GI 9932 - P 2.2.2.2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 71 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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71 participants in 2 patient groups

1

Experimental group

Description:

Early intervention with benzodiazepines in case of prodromal symptoms of an impending relapse

Treatment:

Drug: antipsychotics vs. Lorazepam (Drugs)

2

Active Comparator group

Description:

Early intervention with antipsychotics in case of prodromal symptoms of an impending relapse

Treatment:

Drug: antipsychotics vs. Lorazepam (Drugs)