Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling

This study has been completed.
Sponsor:
Collaborators:
Eli Lilly and Company
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00438776
First received: February 20, 2007
Last updated: December 12, 2011
Last verified: December 2011

February 20, 2007
December 12, 2011
February 2007
March 2009   (final data collection date for primary outcome measure)
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) [ Time Frame: per protocol ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00438776 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling
Not Provided

The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of olanzapine in treating pathological gambling.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Pathological Gambling
  • Drug: olanzapine
    2.5mg to 15mg daily
    Other Name: zyprexa
  • Drug: sugar pill
    matching placebo to olanzapine
    Other Name: fake pill
  • Active Comparator: olanzapine
    active zyprexa (olanzapine)
    Intervention: Drug: olanzapine
  • Placebo Comparator: sugar pill
    Placebo (fake pill)
    Intervention: Drug: sugar pill
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Male and female outpatients aged 18- 75 years of age.
  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:

  1. Patients who have any significant and/or unstable gastrointestinal, neurological, endocrine, cardiovascular, pulmonary, renal, hepatic, immunological or hematological disease; organic brain disease; or cancer as determined by history, physical, ECG, and laboratory examination.
  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.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00438776
F1D-US-X165
Not Provided
Lindner Center of HOPE
Lindner Center of HOPE
  • Eli Lilly and Company
  • University of Cincinnati
Principal Investigator: Susan L McElroy, MD University of Cincinnati
Lindner Center of HOPE
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP