Phase 4
N=57
Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00492336 ↗Enrolled (actual)
57
Serious AEs
1.8%
Results posted
Jun 2013
Primary outcome: Primary: Change in Negative Symptoms — 32.7; 33.5; 31.2; 32.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rasagiline (Pharmacodynamics) (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Negative Symptoms |
32.7; 33.5; 31.2; 32.3; 31.1; 34.1 | — |
| PRIMARY Cognitive Testing - Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Total Score |
76.8; 74.2; 78.7; 75.3; 1.9; 1.1 | — |
| PRIMARY Cognitive Testing - N-Back Neurocognitive Task |
3.47; 3.52; 3.79; 3.66; 0.32; 0.14 | — |
| PRIMARY Cognitive Testing - Probabilistic Learning Task |
70.8; 69.1; 70.4; 68.5; -0.4; -0.7 | — |
| PRIMARY Cognitive Testing - Delayed Discounting |
0.004; 0.018; 0.010; 0.010; 0.003; 0.024 | — |
| SECONDARY Extrapyramidal Symptoms |
1.82; 1.93; 0.96; 1.89; -0.85; -0.04 | — |
| SECONDARY Number of Participants With Akathisia |
20; 21; 20; 21; 3; 5 | — |
| SECONDARY Change in Persistent Positive Symptoms |
8.8; 9.1; 9.2; 9.1; 9.2; 9.8 | — |
| SECONDARY Depressive Symptoms |
2.29; 2.02; 2.19; 1.96; 2.31; 1.52 | — |
| SECONDARY Global Change in Illness Severity |
4.05; 4.31; 4.08; 4.32; 1.00; 4.36 | — |
| SECONDARY Number of Participants Exhibiting Side Effects |
5; 7; 7; 10; 4; 1 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00492336). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.