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
  Purpose

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


Condition Intervention Phase
Pathological Gambling
Drug: olanzapine
Drug: sugar pill
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) [ Time Frame: per protocol ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: February 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438776

Locations
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
Investigators
Principal Investigator: Susan L McElroy, MD University of Cincinnati
  More Information

Publications:
Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00438776     History of Changes
Other Study ID Numbers: F1D-US-X165
Study First Received: February 20, 2007
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gambling
Impulse Control Disorders
Mental Disorders
Contraceptives, Oral
Olanzapine
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 16, 2014