Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

This study has been terminated.
Sponsor:
Collaborators:
Dartmouth-Hitchcock Medical Center
Harvard Medical School
Commonwealth Research Center, Massachusetts
Novartis
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00169039
First received: September 10, 2005
Last updated: February 21, 2006
Last verified: September 2005
  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 National Institute of Mental Health (NIMH):

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
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
Dartmouth-Hitchcock Medical Center
Harvard Medical School
Commonwealth Research Center, Massachusetts
Novartis
Investigators
Principal Investigator: Alan I Green, MD Harvard Medical School
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00169039     History of Changes
Other Study ID Numbers: MH49891
Study First Received: September 10, 2005
Last Updated: February 21, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Clozapine
Chlorpromazine
Schizophrenia
Biochemistry

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

ClinicalTrials.gov processed this record on July 20, 2014