Clinical trial NCT00169039: Clozapine Versus Chlorpromazine for Treatment-Unresponsive Schizophrenia
Official title: Clozapine Response and Biogenic Amines in Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Clozapine
Chlorpromazine
Schizophrenia
Biochemistry
Lead sponsor: Harvard Medical School (HMS and HSDM)
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Dartmouth-Hitchcock Medical Center
name: Commonwealth Research Center, Massachusetts
name: Novartis
First posted: 2005-09-15
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: 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:
measure: Biological measures: plasma and urinary samples of dopamine, norepinephrine and their metabolites.
Other outcomes:
Locations:
city: Jamaica Plain
country: United States
facility: Commonwealth Research Center
state: Massachusetts
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Alan I Green, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.