- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00169091
Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
April 6, 2015 updated by: AlanGreen, Harvard Medical School (HMS and HSDM)
Clozapine or Haloperidol in First Episode Schizophrenia
This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Jamaica Plain, Massachusetts, United States, 02130
- Commonwealth Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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 Names:
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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.
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brief Psychiatric Rating Scale
Time Frame: Weekly during the Acute Treatment Phase and every two weeks in Follow-Up
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This study will use the 24 item BPRS
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Weekly during the Acute Treatment Phase and every two weeks in Follow-Up
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 1996
Primary Completion (Actual)
September 1, 2003
Study Completion
October 1, 2003
Study Registration Dates
First Submitted
September 10, 2005
First Submitted That Met QC Criteria
September 10, 2005
First Posted (Estimate)
September 15, 2005
Study Record Updates
Last Update Posted (Estimate)
April 7, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Schizophrenia
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Dopamine Agents
- Serotonin Antagonists
- Dopamine Antagonists
- GABA Agents
- Anti-Dyskinesia Agents
- GABA Antagonists
- Haloperidol
- Haloperidol decanoate
- Clozapine
Other Study ID Numbers
- R01MH052376 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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