Back to resultsClozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clozapine
Chlorpromazine
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Clozapine, Chlorpromazine, Schizophrenia, Biochemistry
Eligibility Criteria
Inclusion Criteria: 19-60 years of age Diagnosis of schizophrenia BPRS score > 50 Clinical Global Impressions rating > 4 One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content. At least 2 six-week trials of different neuroleptics given at a dosage equivalent to at least 600 mg per day of chlorpromazine OR at least 1 eight-week trial of a neuroleptic given at a dosage equivalent to at least 800 mg per day of chlorpromazine. The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent. Exclusion Criteria: History of substance dependence within the past 2 months Major medical problems precluding the use of clozapine Pregnancy or lactation A serious suicide/homicide risk
Sites / Locations
- Commonwealth Research Center
Outcomes
Primary Outcome Measures
Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.
Secondary Outcome Measures
Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
Full Information
NCT ID
NCT00169039
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
NCT00169039
Brief Title
Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
Official Title
Clozapine Response and Biogenic Amines in Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Terminated
Study Start Date
December 1994 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2002 (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 response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.
Detailed Description
This is a longitudinal double-blind 12-week study of the clinical and biochemical response to clozapine or chlorpromazine in a group of treatment-refractory schizophrenic patients.
The study has 4 phases: (1) A recruitment period; (2) a period of discontinuation of psychotropic medication; (3) a drug-washout period; and (4) a 12-week double-blind trial of clozapine or chlorpromazine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Clozapine, Chlorpromazine, Schizophrenia, Biochemistry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
66 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Clozapine
Intervention Type
Drug
Intervention Name(s)
Chlorpromazine
Primary Outcome Measure Information:
Title
Clinical measures: Brief Psychiatric Rating Scale, Clinical Global Impression, Scale for the Assessment of Negative Symptoms, Simpson-Angus Scale, Abnormal Involuntary Movement Scale and Barnes Akathisia Scale.
Secondary Outcome Measure Information:
Title
Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
19-60 years of age
Diagnosis of schizophrenia
BPRS score > 50
Clinical Global Impressions rating > 4
One of the following: BPRS items rated greater than or equal to 4, conceptual disorganization, suspiciousness, hallucinations, unusual thought content.
At least 2 six-week trials of different neuroleptics given at a dosage equivalent to at least 600 mg per day of chlorpromazine OR at least 1 eight-week trial of a neuroleptic given at a dosage equivalent to at least 800 mg per day of chlorpromazine.
The patient (or the patient's authorized legal representative) must understand the nature of the study and sign the informed consent.
Exclusion Criteria:
History of substance dependence within the past 2 months
Major medical problems precluding the use of clozapine
Pregnancy or lactation
A serious suicide/homicide risk
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
8369230
Citation
Green AI, Alam MY, Boshes RA, Waternaux C, Pappalardo KM, Fitzgibbon ME, Tsuang MT, Schildkraut JJ. Haloperidol response and plasma catecholamines and their metabolites. Schizophr Res. 1993 Jun;10(1):33-7. doi: 10.1016/0920-9964(93)90074-s.
Results Reference
background
PubMed Identifier
8483973
Citation
Green AI, Alam MY, Sobieraj JT, Pappalardo KM, Waternaux C, Salzman C, Schatzberg AF, Schildkraut JJ. Clozapine response and plasma catecholamines and their metabolites. Psychiatry Res. 1993 Feb;46(2):139-49. doi: 10.1016/0165-1781(93)90016-a.
Results Reference
background
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Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
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