View Clinical Trial (Medical Research Study)
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
| City: |
|
Baltimore |
| State: |
|
Maryland |
| Zip Code: |
|
21201 |
| Conditions: |
|
Schizophrenia |
| Purpose: |
|
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.
|
| Study Summary: |
|
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.
|
| 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
|
| NCT ID: |
|
NCT00492336 |
| Primary Contact: |
|
Principal Investigator
Robert W Buchanan, M.D.
Maryland Psychiatric Research Center
Melissa Blake
Phone: 410-402-6042
Email: mblake@mprc.umaryland.edu
|
| Backup Contact: |
|
N/A |
| Location Contact: |
|
Baltimore, Maryland 21201
United States
Mary Olandu, NP
Phone: 410-605-7284
Email: Mary.Olandu@va.med.gov
Site Status: Recruiting |
| Data Source: |
|
ClinicalTrials.gov |
| Date Processed: |
|
May 21, 2013 |
| Modifications to this listing: |
|
Only selected fields are shown, please use the link
below to view all information about this clinical trial. |
|
Click to view Full Listing
|