Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Completed · Phase 4 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT00492336
- Run by
- University of Maryland, Baltimore
- People needed
- 84
- Starts
- 2007-01-01
- Expected to finish
- 2012-02-01
- Last updated by the study team
- 2019-09-25
Who can join
Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- 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
Full record on ClinicalTrials.gov
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