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

H

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

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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