Trial Information
Summary: Ziprasidone augmentation in serotonin reuptake inhibitor-resistant Obsessive-Compulsive Disorder
The purpose of this study is to determine whether the medication
ziprasidone (Geodon) added to a serotonin reuptake inhibitor (SRI)
is effective in the treatment of patients who have previously
experienced little or no response to SRI treatment of
Obsessive-Compulsive Disorder. Ziprasidone is approved by the Food
and Drug Administration (FDA) for the treatment of schizophrenia,
but not approved for the symptoms associated with
obsessive-compulsive disorder. Study volunteers will be randomly
assigned to receive either ziprasidone or placebo (sugar pill) in
addition to their SRI for a period of 8 weeks. Study volunteers
will have a 50% chance of being given active medication.
Assessments included in the study will be: a psychiatric and
medical evaluation, lab tests (physical exam, routine blood test,
urinalysis, urine drug screen, an electrocardiogram (EKG) and a
blood pregnancy test (females only).) Participants will be closely
monitored throughout the study by a psychiatrist. GCO#
02-0150
No Compensation Provided
Patient Inclusion/Exclusion Criteria:
Men and women aged 18 - 65 years who have had little or no
response to more than 1 prior trial with an SRI will be eligible to
enter the program. Study volunteers should have a primary diagnosis
of Obsessive-Compulsive Disorder and should be physically healthy
without any serious medical, psychiatric, or neurological illnesses
other than OCD. Study volunteers should be stable on an SRI for at
least 3 months prior to enrollment.
Study volunteers should not be on any other forms of psychiatric
medication other than an SRI; those on other medications must be
willing to come off their medication. Please contact the Study
Coordinator below for further exclusion criteria.
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Contact:
Suah Kim
Mount Sinai Medical Center
One Gustave L. Levy Place
New York, NY 10029
Telephone: 212-659-8732
Fax: 212-987-4031
Email:
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Trial listings updated: June 1, 2008 at 5:43:38 AM