Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Clozapine or Haloperidol in First Episode Schizophrenia

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00169091

Enrollment

Registered

2005-09-15

Start date

1996-03-31

Completion date

2003-10-31

Last updated

2015-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Clozapine, Haloperidol, Schizophrenia

Brief summary

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

Detailed 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.

Interventions

DRUGClozapine

Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 12.5 mg on Day 1 to up to 300 mg on Day 12.

DRUGHaloperidol

Medication will be divided into twice daily dosing and administered in a blinded fashion. The medication will be tapered from 2 mg on Day 1 to up to 12 mg on Day 12.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Brief Psychiatric Rating Scale	Weekly during the Acute Treatment Phase and every two weeks in Follow-Up	This study will use the 24 item BPRS

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026