Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2012-02-29

Brief Summary

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This is a study of a new medication for the treatment of cognitive impairments (thinking difficulties) and negative symptoms in people with schizophrenia. The new medication is rasagiline. Rasagiline is a drug which has been approved by the Food and Drug Administration for the treatment of Parkinson's disease. It is used to treat cognitive problems.

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Detailed Description

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The study will consist of two phases: a 4-week continued stability phase (lead-in phase) and a 12-week double-blind treatment phase. In the lead-in phase, subjects receiving antipsychotic medication, who manifest moderate to severe and persistent negative symptoms, will remain on their maintenance regimen for at least four weeks. The treatment phase will be a 12-week, parallel groups, double-blind, placebo-controlled trial of adjunctive rasagiline (1 mg/day), a selective MAO-B oxidase inhibitor.

Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Rasagiline

Treatment with Rasagiline

Group Type ACTIVE_COMPARATOR

rasagiline (Pharmacodynamics)

Intervention Type DRUG

Rasagiline 1 mg/day for 12 weeks

Inactive pill

Treatment with Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo 1 tablet each day

Interventions

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rasagiline (Pharmacodynamics)

Rasagiline 1 mg/day for 12 weeks

Intervention Type DRUG

Placebo

Placebo 1 tablet each day

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects will meet DSM-IV criteria for schizophrenia or schizoaffective disorder.
* Current treatment with one or more second generation antipsychotics, except ziprasidone
* On same second generation antipsychotic(s)for at least 56 days
* On same dose of second generation antipsychotic(s)for at least 30 days
* 22-item SANS: Total score (i.e.all items minus global items and poverty of content of speech)greater than 20 or global Rating of Affective Flattening greater than or equal to 3 or global Rating of alogia greater than or equal to 3
* BPRS: Sum of the four positive symptom items less than or equal to 16 (items 4,11,12,15)
* BPRS: Sum of the four Anxiety/Depression Factor items less than or equal to 14 (items 1,2,5,9)
* Simpson-Angus Scale: Total score less than or equal to 8

Exclusion Criteria

* DSM-IV Major Depressive Disorder within last 6 months
* Current treatment with ziprasidone
* DSM-IV diagnosis of alcohol or substance dependence within the last 6 months
* DSM-IV criteria for alcohol or substance abuse within the last month
* evidence of illicit substance use, as identified with urine toxicology screen
* History of an organic brain disorder, mental retardation,epilepsy, or a medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol. See those listed below
* Uncontrolled hypertension defined as BP exceeding 145/90 on 3 consecutive readings despite adequate treatment, pheochromocytoma, melanoma, hepatic insufficiency
* Pregnancy or lactation in females
* Pheochromocytoma
* Melanoma
* Hepatic insufficiency

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No