Clinical trial NCT00492336: Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Official title: Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Cognitive impairments
Negative symptoms
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2007-06-27
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: Change in Negative Symptoms
timeFrame: Every 4 weeks over a 12 week period
measure: Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score
timeFrame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
measure: Cognitive Testing - N-Back Neurocognitive Task
timeFrame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
measure: Cognitive Testing - Probabilistic Learning Task
timeFrame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
measure: Cognitive Testing - Delayed Discounting
timeFrame: Beginning of treatment phase (week 0) and end of treatment phase (week 12)
Secondary outcomes:
measure: Extrapyramidal Symptoms
timeFrame: Baseline (Week 0) and End of Study (Week 12)
measure: Number of Participants With Akathisia
timeFrame: Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.
measure: Change in Persistent Positive Symptoms
timeFrame: Every 4 weeks for 12 weeks.
measure: Depressive Symptoms
timeFrame: Every 4 weeks for 12 weeks.
measure: Global Change in Illness Severity
timeFrame: Every 4 weeks for 12 weeks.
measure: Number of Participants Exhibiting Side Effects
timeFrame: Every week for 12 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Keypoint Mental health Center
state: Maryland
city: Catonsville
country: United States
facility: Maryland Psychiatric REsearch Center
state: Maryland
city: Catonsville
country: United States
facility: Mosaic Community Mental health Center
state: Maryland
city: Dundalk
country: United States
facility: Keypoint Mental health Center
state: Maryland
Study officials:
affiliation: University of Maryland, College Park
name: Robert W Buchanan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buchanan RW, Weiner E, Kelly DL, Gold JM, Keller WR, Waltz JA, McMahon RP, Gorelick DA. Rasagiline in the Treatment of the Persistent Negative Symptoms of Schizophrenia. Schizophr Bull. 2015 Jul;41(4):900-8. doi: 10.1093/schbul/sbu151. Epub 2014 Nov 2.