Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

• Status: Completed
• Trial end date: 2012-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Maryland; University of Maryland, Baltimore
• Collaborator: Stanley Medical Research Institute
• Treatments: Rasagiline

Criteria

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