Pathological GamblingPhase 3NCT00438776
Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling
A Phase 3 study testing olanzapine and sugar pill in people with Pathological Gambling, run by Lindner Center of HOPE at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of olanzapine in treating pathological gambling. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pathological Gambling
- What is being tested?
- olanzapine and sugar pill
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Mar 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female outpatients aged 18- 75 years of age.
- 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.
- All patients will have a complete medical and psychiatric history, physical examination, laboratories, and ECG before study entry.
- Baseline laboratory values and ECG must be normal, or abnormalities must be clinically insignificant.
- Patients will not have received any psychotropic medication for at least one week prior to the first study visit.
Who cannot join
- 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.
- 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).
- 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.
- Patients who meet DSM-IV criteria for antisocial or borderline personality disorder.
- 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.
- Patients who have taken any psychiatric medication within 7 days prior to the screening assessment.
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- Patients who have a history of hypersensitivity to olanzapine.
- Patients who display clinically significant suicidal ideation.
- 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.
- Patients who exhibit or suggest that they may display behavior that will not be conducive to the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267-0559
About this study
The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of olanzapine in treating pathological gambling.
- Conditions
- Pathological Gambling
- Being tested
- olanzapine, sugar pill
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called zyprexa
2.5mg to 15mg daily
sugar pillDrug
Also called fake pill
matching placebo to olanzapine
| Study group | Role | What they receive |
|---|---|---|
| olanzapine | Active comparator | active zyprexa (olanzapine) Receives: Drug: olanzapine |
| sugar pill | Placebo comparator | Placebo (fake pill) Receives: Drug: sugar pill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
Measured: per protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pathological GamblingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindner Center of HOPE
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Susan L McElroy, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00438776
- Sponsor's protocol ID
- F1D-US-X165
- Status last verified
- Dec 2011
- First submitted
- 20 Feb 2007
- Last updated
- 13 Dec 2011
- Results posted
- No
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.
PubMed 18251624
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Trial of Olanzapine in Outpatients With Pathological Gambling
- ClinicalTrials.gov ID
- NCT00438776
- Acronym / sponsor ID
- F1D-US-X165
- Conditions
- Pathological Gambling
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Lindner Center of HOPEUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, University of Cincinnati
- Study start
- Feb 2007
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 22 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the efficacy (effectiveness) and safety of olanzapine in treating pathological gambling.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| olanzapine | Active comparator | Drug: olanzapineactive zyprexa (olanzapine) |
| sugar pill | Placebo comparator | Drug: sugar pillPlacebo (fake pill) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male and female outpatients aged 18- 75 years of age.
- 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.
- All patients will have a complete medical and psychiatric history, physical examination, laboratories, and ECG before study entry.
- Baseline laboratory values and ECG must be normal, or abnormalities must be clinically insignificant.
- Patients will not have received any psychotropic medication for at least one week prior to the first study visit.
Key exclusion criteria (10 listed)
- 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.
- 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).
- 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.
- Patients who meet DSM-IV criteria for antisocial or borderline personality disorder.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| olanzapineAlso: zyprexa2.5mg to 15mg daily | Drug | olanzapine |
| sugar pillAlso: fake pillmatching placebo to olanzapine | Drug | sugar pill |
Primary outcome
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS)
Time frame: per protocol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.
- Results publication: PubMed 18251624McElroy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan L McElroy, MD principal investigator
University of Cincinnati
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing olanzapine and sugar pill in people with Pathological Gambling, run by Lindner Center of HOPE at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Gambling Adaptation of the Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) (time frame: per protocol). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00438776, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.