Rasagiline in the Treatment of Persistent Negative Symptoms of Schizophrenia



Status:Completed
Conditions:Schizophrenia
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 64
Updated:4/22/2018
Start Date:January 2007
End Date:February 2012

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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.

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
We found this trial at
5
sites
Catonsville, Maryland 21228
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Catonsville, MD
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Baltimore, Maryland 21201
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Baltimore, MD
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Catonsville, Maryland 21228
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Catonsville, MD
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Catonsville, Maryland 21228
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Catonsville, MD
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Dundalk, Maryland 21222
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Dundalk, MD
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