Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling

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

Study Overview

• Status: Completed
• Conditions: Pathological Gambling
• Intervention / Treatment: Drug: olanzapine; Drug: sugar pill

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0559
      • University of Cincinnati Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: olanzapine; active zyprexa (olanzapine)	Drug: olanzapine; 2.5mg to 15mg daily; Other Names: zyprexa
PLACEBO_COMPARATOR: sugar pill; Placebo (fake pill)	Drug: sugar pill; matching placebo to olanzapine; Other Names: fake pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)	per protocol

Collaborators and Investigators

• Sponsor: Lindner Center of HOPE
• Collaborators: Eli Lilly and Company; University of Cincinnati

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): March 1, 2009

Study Registration Dates

• First Submitted: February 20, 2007
• First Submitted That Met QC Criteria: February 21, 2007
• First Posted (ESTIMATE): February 22, 2007

Study Record Updates

• Last Update Posted (ESTIMATE): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Gambling; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Olanzapine
• Other Study ID Numbers: F1D-US-X165