Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Robert W. Buchanan, M.D., University of Maryland
ClinicalTrials.gov Identifier:
NCT00492336
First received: June 26, 2007
Last updated: June 17, 2013
Last verified: June 2013
  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:


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 over a 12 week period ] [ Designated as safety issue: No ]
    Scores on the subscales are combined (summed) to compute a total score. There are a total of 17 subscales. Each subscale ranges from 0="Not at all" to 5="Severe". Every 4 weeks the summed subscale scores provide a total score for that week (0-85). These total scores from each week are then combined (summed) for an overall score and then averaged for the two groups after the 12 week period.


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 ]

Enrollment: 84
Study Start Date: January 2007
Study Completion Date: February 2012
Primary Completion Date: February 2012 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492336

Locations
United States, Maryland
Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Keypoint Mental health Center
Catonsville, Maryland, United States, 21228
Maryland Psychiatric REsearch Center
Catonsville, Maryland, United States, 21228
Mosaic Community Mental health Center
Catonsville, Maryland, United States, 21228
Keypoint Mental health Center
Dundalk, Maryland, United States, 21222
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., Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier: NCT00492336     History of Changes
Other Study ID Numbers: HP-00043807, H-27877
Study First Received: June 26, 2007
Results First Received: February 1, 2013
Last Updated: June 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Maryland:
Cognitive impairments
Negative symptoms

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Rasagiline
Central Nervous System Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Neuroprotective Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014