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Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

H

Harvard Medical School (HMS and HSDM)

Status and phase

Terminated
Phase 4

Conditions

Schizophrenia

Treatments

Drug: Clozapine
Drug: Haloperidol

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT00169091
R01MH052376 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

Full description

This is a longitudinal double blind, 2- 5 year study of the clinical, neuroendocrine and biochemical response to clozapine (CLOZ) and haloperidol (HAL) in a group of "first episode" schizophrenic (RDC) patients. Within the protocol, we compare the differential effects of the two drugs over the short term (12 weeks) and the long-term (2-5 years); we evaluate the relationship between change in prolactin level and clinical response of the patients; and we search for biochemical predictors and correlates of clinical response. To achieve the study aims, we employ a drug-washout period, a 12-week acute treatment period; and an 88 - 260 week follow-up period.

Enrollment

32 patients

Sex

All

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • RDC diagnosis of schizophrenia
  • Men and women, without regard to race/ethnicity,
  • Aged 18-45
  • Acutely psychotic with a score of at least 3 on one of the psychotic scale items of the Brief Psychiatric Rating Scale (BPRS) (hallucinations, delusions, conceptual disorganization) and a total BPRS of > 21 (on a 0 - 6 scale);
  • Require treatment with neuroleptic drugs on a clinical basis;
  • The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent;
  • Be within the first episode of a psychotic disorder;
  • Have a history of neuroleptic treatment of < 12 weeks;
  • Likely to remain in the study for 2 years.

Exclusion criteria

  • Substance dependence in the last six months
  • History of seizure or blood dyscrasia
  • Major medical illness
  • Pregnancy or Lactation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

32 participants in 2 patient groups

Clozapine
Experimental group
Description:
Clozapine 12.5-300 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
Treatment:
Drug: Clozapine
Haloperidol
Active Comparator group
Description:
Haloperidol 2-12 mg taken orally per day for 12 weeks in the acute phase of the study and up to 130 weeks (total) in the Follow-up portion of the study.
Treatment:
Drug: Haloperidol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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