Clozapine Versus Haloperidol for Treating the First Episode of 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:
NCT00169091
First received: September 10, 2005
Last updated: February 21, 2006
Last verified: September 2005
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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 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Clozapine or Haloperidol in First Episode 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, 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 |
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
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: | NCT00169091 History of Changes |
| Other Study ID Numbers: | MH52376 |
| 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 Haloperidol Schizophrenia |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Clozapine Haloperidol Haloperidol decanoate Serotonin Antagonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Antipsychotic Agents Tranquilizing Agents |
Central Nervous System Depressants Central Nervous System Agents Therapeutic Uses Psychotropic Drugs GABA Antagonists GABA Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Gastrointestinal Agents Dopamine Antagonists Dopamine Agents Anti-Dyskinesia Agents |
ClinicalTrials.gov processed this record on May 23, 2013