Working… Menu

Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00438776
Recruitment Status : Completed
First Posted : February 22, 2007
Last Update Posted : December 13, 2011
Eli Lilly and Company
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

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

Condition or disease Intervention/treatment Phase
Pathological Gambling Drug: olanzapine Drug: sugar pill Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : February 2007
Actual Primary Completion Date : March 2009
Actual Study Completion Date : March 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: olanzapine
active zyprexa (olanzapine)
Drug: olanzapine
2.5mg to 15mg daily
Other Name: zyprexa

Placebo Comparator: sugar pill
Placebo (fake pill)
Drug: sugar pill
matching placebo to olanzapine
Other Name: fake pill

Primary Outcome Measures :
  1. Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) [ Time Frame: per protocol ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00438776

Layout table for location information
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Lindner Center of HOPE
Eli Lilly and Company
University of Cincinnati
Layout table for investigator information
Principal Investigator: Susan L McElroy, MD University of Cincinnati

Publications of Results:
Layout table for additonal information
Responsible Party: Lindner Center of HOPE Identifier: NCT00438776     History of Changes
Other Study ID Numbers: F1D-US-X165
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Disruptive, Impulse Control, and Conduct Disorders
Mental Disorders
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents