Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

This study has been terminated.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Novartis
Information provided by (Responsible Party):
AlanGreen, Harvard Medical School
ClinicalTrials.gov Identifier:
NCT00169091
First received: September 10, 2005
Last updated: April 6, 2015
Last verified: April 2015
  Purpose

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


Condition Intervention Phase
Schizophrenia
Drug: Clozapine
Drug: Haloperidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clozapine or Haloperidol in First Episode Schizophrenia

Resource links provided by NLM:


Further study details as provided by Harvard Medical School:

Primary Outcome Measures:
  • Brief Psychiatric Rating Scale [ Time Frame: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up ] [ Designated as safety issue: No ]
    This study will use the 24 item BPRS


Enrollment: 32
Study Start Date: March 1996
Estimated Study Completion Date: October 2003
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Clozapine
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.
Drug: Clozapine
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.
Other Name: Clozaril
Active Comparator: Haloperidol
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.
Drug: Haloperidol
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.
Other Name: Haldol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169091

Locations
United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Harvard Medical School
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Novartis
Investigators
Principal Investigator: Alan I Green, MD Harvard Medical School
  More Information

Publications:
Responsible Party: AlanGreen, Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth, Harvard Medical School
ClinicalTrials.gov Identifier: NCT00169091     History of Changes
Other Study ID Numbers: R01 MH52376, R01MH052376
Study First Received: September 10, 2005
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Harvard Medical School:
Clozapine
Haloperidol
Schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Clozapine
Haloperidol
Haloperidol decanoate
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
GABA Agents
GABA Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 26, 2015