Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Maryland.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Maryland
Collaborator:
Stanley Medical Research Institute
Information provided by:
University of Maryland
ClinicalTrials.gov Identifier:
NCT00492336
First received: June 26, 2007
Last updated: April 23, 2011
Last verified: April 2011
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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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: rasagiline (Pharmacodynamics) Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Rasagiline mesylate
U.S. FDA Resources
Further study details as provided by University of Maryland:
Primary Outcome Measures:
- Scale for the Assessment of Negative Symptoms (SANS) [ Time Frame: Every 4 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Neuropsychological tests, including RBANS, probabilistic learning task, and N-Back task [ Time Frame: Beginning of treatment phase (week 0) and end of treatment phase (week 12) ] [ Designated as safety issue: No ]
- Simpson Angus Scale [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]
- Side Effect checklist and vital signs [ Time Frame: Weekly ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | July 2011 |
| Estimated Primary Completion Date: | July 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Rasagiline
Treatment with Rasagiline
|
Drug: rasagiline (Pharmacodynamics)
Rasagiline 1 mg/day for 12 weeks
|
|
Placebo Comparator: Inactive pill
Treatment with Placebo
|
Drug: Placebo
Placebo 1 tablet each day
|
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| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00492336
Contacts
| Contact: Melissa Blake | 410-402-6042 | mblake@mprc.umaryland.edu |
Locations
| United States, Maryland | |
| Baltimore VA Medical Center | Recruiting |
| Baltimore, Maryland, United States, 21201 | |
| Contact: Mary Olandu, NP 410-605-7284 Mary.Olandu@va.med.gov | |
| Principal Investigator: Robert W Buchanan, M.D. | |
| Maryland Psychiatric REsearch Center | Recruiting |
| Catonsville, Maryland, United States, 21228 | |
| Contact: M P Ball, RN 410-402-7548 pball@mprc.umaryland.edu | |
| Principal Investigator: Robert W Buchanan, M.D. | |
| Mosaic Community Mental health Center | Recruiting |
| Catonsville, Maryland, United States, 21228 | |
| Contact: Melissa Blake, B.A. 410-402-6042 mblake@mprc.umaryland.edu | |
| Principal Investigator: Robert W Buchanan, M.D. | |
| Keypoint Mental health Center | Recruiting |
| Catonsville, Maryland, United States, 21228 | |
| Contact: Melissa Blake, B.A. 410-402-6042 mblake@mprc.umaryland.edu | |
| Principal Investigator: Robert W Buchanan, M.D. | |
| Keypoint Mental health Center | Recruiting |
| Dundalk, Maryland, United States, 21222 | |
| Contact: Melissa Blake, B.A. 410-402-6042 mblake@mprc.umaryland.edu | |
| Principal Investigator: Robert W Buchanan, M.D. | |
Sponsors and Collaborators
University of Maryland
Stanley Medical Research Institute
Investigators
| Principal Investigator: | Robert W Buchanan, M.D. | University of Maryland |
More Information
No publications provided
| Responsible Party: | Robert W. Buchanan, M.D., Maryland Psychiatric Research Center/University of Maryland Baltimore |
| ClinicalTrials.gov Identifier: | NCT00492336 History of Changes |
| Other Study ID Numbers: | HP-00043807, H-27877 |
| Study First Received: | June 26, 2007 |
| Last Updated: | April 23, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Maryland:
|
Cognitive impairments Negative symptoms |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Rasagiline Monoamine Oxidase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Neuroprotective Agents Protective Agents Physiological Effects of Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013