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One Year Drug Treatment in First-Episode Schizophrenia

H

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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