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Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia | Clinical Trials | Clareo Health

COMPLETEDPHASE4

Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

NCT00492336•University of Maryland, Baltimore

Summary

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.

Detailed Description

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.

Eligibility

Age

18 - 64 years

Sex

ALL

Healthy Volunteers

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
+1 more criteria

Locations (5)

Baltimore VA Medical Center

Baltimore, Maryland, United States

Keypoint Mental health Center

Catonsville, Maryland, United States

Maryland Psychiatric REsearch Center

Catonsville, Maryland, United States

Mosaic Community Mental health Center

Catonsville, Maryland, United States

Keypoint Mental health Center

Dundalk, Maryland, United States

Key Dates

Start Date

January 1, 2007

Primary Completion Date

February 1, 2012

Completion Date

February 1, 2012

Last Updated

September 25, 2019

Enrollment

ACTUAL participants

Conditions

Schizophrenia

Interventions

rasagiline (Pharmacodynamics)

DRUG

Placebo

DRUG

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Psychotic DisordersSchizophrenia Spectrum Disorders

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RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383

Schizophrenia Spectrum and Other Psychotic DisordersSchizophrenia+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

Inclusion Criteria

Exclusion Criteria

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