Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia - Tabular View

Tracking Information

First Received Date ^ICMJE

September 10, 2005

Last Updated Date

February 21, 2006

Start Date ^ICMJE

March 1996

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00169091 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Official Title ^ICMJE

Clozapine or Haloperidol in First Episode Schizophrenia

Brief Summary

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

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.

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: Clozapine
Drug: Haloperidol

Study Arms / Comparison Groups

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.

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

July 2003

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00169091

Responsible Party

Study ID Numbers ^ICMJE

MH52376

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Dartmouth-Hitchcock Medical Center
Harvard University
Commonwealth Research Center
Novartis

Investigators ^ICMJE

Principal Investigator:

Alan I Green, MD

Harvard University

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP