Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia

NCT00169039 | Terminated Phase 4

• 1 other identifier: R01MH049891
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the physical response to clozapine or chlorpromazine in people with schizophrenia that has not improved with treatment.

Conditions

Schizophrenia

Keywords

Clozapine; Chlorpromazine; Schizophrenia; Biochemistry

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.

Interventions

Clozapine DRUG

Chlorpromazine DRUG

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Harvard Medical School (HMS and HSDM): lead
• National Institute of Mental Health (NIMH): collaborator
• Dartmouth-Hitchcock Medical Center: collaborator
• Commonwealth Research Center, Massachusetts: collaborator
• Novartis: collaborator

Study Sites (1)

Commonwealth Research Center

Jamaica Plain, Massachusetts, 02130, United States

Location

Related Publications (2)

• 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.

  PMID: 8369230 BACKGROUND

• 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.

  PMID: 8483973 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Interventions

Clozapine; Chlorpromazine

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzazepines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenothiazines; Sulfur Compounds; Organic Chemicals

Study Officials

• Alan I Green, MD

  Harvard Medical School (HMS and HSDM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair, Department of Psychiatry Geisel School of Medicine at Dartmouth

Study Record Dates

• First Submitted: September 10, 2005
• First Posted: September 15, 2005
• Study Start: December 1, 1994
• Study Completion: February 1, 2002
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

US (1)