Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

This study has been terminated.
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Commonwealth Research Center, Massachusetts
Novartis
Information provided by (Responsible Party):
AlanGreen, Harvard Medical School
ClinicalTrials.gov Identifier:
NCT00169039
First received: September 10, 2005
Last updated: April 6, 2015
Last verified: April 2015
  Purpose
This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Clozapine Response and Biogenic Amines in Schizophrenia

Resource links provided by NLM:


Further study details as provided by Harvard Medical School:

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.

Estimated Enrollment: 66
Study Start Date: December 1994
Estimated Study Completion Date: February 2002
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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT00169039

Locations
United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130
Sponsors and Collaborators
Harvard Medical School
National Institute of Mental Health (NIMH)
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: NCT00169039     History of Changes
Other Study ID Numbers: R01MH049891 
Study First Received: September 10, 2005
Last Updated: April 6, 2015
Health Authority: United States: Federal Government

Keywords provided by Harvard Medical School:
Clozapine
Chlorpromazine
Schizophrenia
Biochemistry

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Clozapine
Chlorpromazine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
GABA Antagonists
GABA Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on July 28, 2016