Back to resultsClozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clozapine
Haloperidol
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Clozapine, Haloperidol, Schizophrenia
Eligibility 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
Sites / Locations
- Commonwealth Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Clozapine
Haloperidol
Arm 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.
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.
Outcomes
Primary Outcome Measures
Brief Psychiatric Rating Scale
This study will use the 24 item BPRS
Secondary Outcome Measures
Full Information
NCT ID
NCT00169091
First Posted
September 10, 2005
Last Updated
April 6, 2015
Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Novartis
1. Study Identification
Unique Protocol Identification Number
NCT00169091
Brief Title
Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
Official Title
Clozapine or Haloperidol in First Episode Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Study Start Date
March 1996 (undefined)
Primary Completion Date
September 2003 (Actual)
Study Completion Date
October 2003 (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard Medical School (HMS and HSDM)
Collaborators
National Institute of Mental Health (NIMH), Dartmouth-Hitchcock Medical Center, Commonwealth Research Center, Massachusetts, Novartis
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Clozapine, Haloperidol, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Clozapine
Arm Type
Experimental
Arm 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.
Arm Title
Haloperidol
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Clozapine
Other Intervention Name(s)
Clozaril
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brief Psychiatric Rating Scale
Description
This study will use the 24 item BPRS
Time Frame
Weekly during the Acute Treatment Phase and every two weeks in Follow-Up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan I Green, MD
Organizational Affiliation
Harvard Medical School (HMS and HSDM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Commonwealth Research Center
City
Jamaica Plain
State/Province
Massachusetts
ZIP/Postal Code
02130
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
9384923
Citation
Green AI, Schildkraut JJ. Should clozapine be a first-line treatment for schizophrenia? The rationale for a double-blind clinical trial in first-episode patients. Harv Rev Psychiatry. 1995 May-Jun;3(1):1-9. doi: 10.3109/10673229509017159.
Results Reference
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Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia
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