Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

This study has been terminated.

First Received: September 10, 2005 Last Updated: February 21, 2006 History of Changes

Sponsor:	National Institute of Mental Health (NIMH)
Collaborators:	Dartmouth-Hitchcock Medical Center Harvard University Commonwealth Research Center Novartis
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00169091

Purpose

This study will examine the physical responses brought on by clozapine and haloperidol in people experiencing their first episode of schizophrenia.

Condition	Intervention	Phase
Schizophrenia	Drug: Clozapine Drug: Haloperidol	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Clozapine or Haloperidol in First Episode Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Haloperidol Haloperidol decanoate Haloperidol lactate Clozapine

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Clinical Measures: Brief Psychiatric Rating Scale, Scale for the Assessment of Negative Symptoms, Clinical Global Impression, and a neuropsychological battery.

Secondary Outcome Measures:

Quality of Life Scale ; safety assessment included complete blood counts, and extrapyramidal symptom scales. Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites and serum prolactin and plasma cortisol.

Estimated Enrollment:	44
Study Start Date:	March 1996
Estimated Study Completion Date:	July 2003

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.

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00169091

Locations

United States, Massachusetts
Commonwealth Research Center
Jamaica Plain, Massachusetts, United States, 02130

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Dartmouth-Hitchcock Medical Center

Harvard University

Commonwealth Research Center

Novartis

Investigators

Principal Investigator:

Alan I Green, MD

Harvard University

More Information

Publications:

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. Review.

Study ID Numbers:	MH52376
Study First Received:	September 10, 2005
Last Updated:	February 21, 2006
ClinicalTrials.gov Identifier:	NCT00169091 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Clozapine
Haloperidol
Schizophrenia

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Haloperidol
Schizophrenia
Serotonin Antagonists
Mental Disorders
Therapeutic Uses
Schizophrenia and Disorders with Psychotic Features
Tranquilizing Agents
Gastrointestinal Agents

Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
GABA Antagonists
Haloperidol decanoate
Serotonin Agents
Autonomic Agents
Clozapine
GABA Agents
Dopamine Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009