Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling
NCT ID: NCT00438776
Last Updated: 2011-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
42 participants
INTERVENTIONAL
2007-02-28
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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olanzapine
active zyprexa (olanzapine)
olanzapine
2.5mg to 15mg daily
sugar pill
Placebo (fake pill)
sugar pill
matching placebo to olanzapine
Interventions
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olanzapine
2.5mg to 15mg daily
sugar pill
matching placebo to olanzapine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients will have problematic gambling behavior of at least 6 months duration that meets the DSM-IV definition of pathological gambling and a South Oaks Gambling Screen Score greater than 5.
3. All patients will have a complete medical and psychiatric history, physical examination, laboratories, and ECG before study entry.
4. Baseline laboratory values and ECG must be normal, or abnormalities must be clinically insignificant.
5. Patients will not have received any psychotropic medication for at least one week prior to the first study visit.
Exclusion Criteria
2. Patients who are pregnant, intending to become pregnant, nursing, at risk for pregnancy, or not practicing medically acceptable birth control. (A blood pregnancy test will be performed at the screening visit).
3. Patients who have ever had psychotic symptoms, who have ever met DSM-IV criteria for a manic episode (i.e., have bipolar I disorder), or who have met criteria for DSM-IV psychoactive substance dependence in the past 1 month.
4. Patients who meet DSM-IV criteria for antisocial or borderline personality disorder.
5. Patients who use any medications which, in the judgment of the investigator, might have psychotropic effects, or interact unfavorably with olanzapine. For example, patients taking diet pills or stimulants will not be enrolled.
6. Patients who have taken any psychiatric medication within 7 days prior to the screening assessment.
7. Patients who have a history of hypersensitivity to olanzapine.
8. Patients who display clinically significant suicidal ideation.
9. Patients who have recently (within the past 3 months) begun any type of non-pharmacologic treatment for pathological gambling (including psychotherapy, behavior therapy, group therapy, or family therapy). This does not exclude participation in support groups (e.g., Gamblers Anonymous.) Patients who have been involved in long-standing psychological therapies (e.g., psychotherapy for at least the last 3 months) will be permitted to continue in that therapy provided that no new therapeutic technique or increase in frequency of psychotherapy occurs concurrent with the study.
10. Patients who exhibit or suggest that they may display behavior that will not be conducive to the study procedures.
18 Years
75 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
University of Cincinnati
OTHER
Lindner Center of HOPE
OTHER
Responsible Party
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Principal Investigators
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Susan L McElroy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Countries
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References
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McElroy SL, Nelson EB, Welge JA, Kaehler L, Keck PE Jr. Olanzapine in the treatment of pathological gambling: a negative randomized placebo-controlled trial. J Clin Psychiatry. 2008 Mar;69(3):433-40. doi: 10.4088/jcp.v69n0314.
Other Identifiers
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F1D-US-X165
Identifier Type: -
Identifier Source: org_study_id