One Year Drug Treatment in First-Episode Schizophrenia

Heinrich-Heine University, Duesseldorf

Status and phase: Completed; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Haloperidol, Risperidone (drug)

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT00159081

01GI 9932 - P 2.2.2.1 / 1

Details and patient eligibility

About

Prospective, randomized, double-blind, multi-center study on 1 year course and treatment outcome under low-dose typical (haloperidol) vs. atypical neuroleptics (risperidone) in first-episode schizophrenia.

Full description

The objective of this multi-center study is to optimize the long-term treatment of patients with first episode schizophrenia. This investigation should contribute to the issue of effective relapse prevention in first-episode patients. 1-year maintenance neuroleptic treatment is done with low dose haloperidol or risperidone (target dose 2-4 mg/die).

Enrollment: 159 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• After the acute treatment of the first-episode in schizophrenia (according ICD-10 F20)
• Age between 18 and 55
• Informed consent

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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159 participants in 2 patient groups

1

Experimental group

Description:

Maintenance antipsychotic treatment with risperidone

Treatment:

Drug: Haloperidol, Risperidone (drug)

2

Active Comparator group

Description:

Maintenance antipsychotic treatment with haloperidol in low-dose

Treatment:

Drug: Haloperidol, Risperidone (drug)