Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

University of Maryland Baltimore (UMB)

Status and phase

Completed

Phase 4

Conditions

Schizophrenia

Treatments

Drug: rasagiline (Pharmacodynamics)

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00492336

HP-00043807

H-27877 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

84 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No 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
Hepatic insufficiency