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

June 26, 2007
June 17, 2013
January 2007
February 2012   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00492336 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Drug: rasagiline (Pharmacodynamics)
    Rasagiline 1 mg/day for 12 weeks
  • Drug: Placebo
    Placebo 1 tablet each day
  • Active Comparator: Rasagiline
    Treatment with Rasagiline
    Intervention: Drug: rasagiline (Pharmacodynamics)
  • Placebo Comparator: Inactive pill
    Treatment with Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
84
February 2012
February 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00492336
HP-00043807, H-27877
Yes
Robert W. Buchanan, M.D., University of Maryland
University of Maryland
Stanley Medical Research Institute
Principal Investigator: Robert W Buchanan, M.D. University of Maryland
University of Maryland
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP