Pathological GamblingPhase 2NCT01215357
Clinical Study to Determine if Ecopipam Can Reduce Urges to Gamble
A Phase 2 study testing Ecopipam in people with Pathological Gambling, run by Emalex Biosciences Inc. at 4 sites in United States.
Trial summary
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with 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?
- Ecopipam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2010to Aug 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
- Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
- Subject must have gambling urges of at least moderate intensity
Who cannot join
- Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
- Subjects with major depressive episode within the last 2 years
- Subjects with a history of attempted suicide
- Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
- Subjects with a history of epilepsy or seizures
- Subjects with a myocardial infarction (heart attack) with in the last 6 months
- Subjects with a lifetime history of bipolar disorder, dementia, schizophrenia, or any psychotic disorder
- Subjects with current of recent DSM-IV diagnosis of substance abuse or dependence (with the exception of nicotine)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Carver College of Medicine, University of Iowa
Iowa City, Iowa, 52242
University of California, Los Angeles
Los Angeles, California, 90095
University of Minnesota School of Medicine
Minneapolis, Minnesota, 55454
Yale University
New Haven, Connecticut, 06519
About this study
Official title: Ecopipam Treatment of Pathological Gambling
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
Read the detailed description
The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.
- Conditions
- Pathological Gambling
- Being tested
- Ecopipam
- Keywords
- Pathological Gambling, ecopipam, Dopamine
- Medical subject headings
- Gambling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EcopipamDrug
Also called PSYRX101, SCH 39166
50mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Ecopipam | Experimental | Ecopipam is a selective antagonist of one the classes of dopamine receptor. Receives: Drug: Ecopipam |
| Placebo | Placebo comparator | Placebo given first week of the study. Receives: Drug: Ecopipam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.
Measured: Baseline and 6 weeks
Secondary outcomes (3)
Type, Frequency and Severity of Side Effects
All side effects of the drug will be monitored and recorded
Measured: 6 weeks
Statistically Significant Changes in the Gambling Symptom Assessment Scale
It is expected that there will be decreases in this scale
Measured: 6 weeks
Effects on the Clinical Global Impression
Clinician's Global Impression is used assess severity and changes in clinical symptoms during and at the end of the study
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emalex Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Psyadon Pharma
- Responsible party
- Sponsor
- Investigators
- Jon Grant, MD, Principal investigator, Univ. of MinnesotaDonald Black, MD, Principal investigator, Iowa UniversityTimothy Fong, MD, Principal investigator, University of California, Los AngelesMarc Potenza, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215357
- Sponsor's protocol ID
- PSY201
- Status last verified
- Feb 2013
- First submitted
- 4 Oct 2010
- Last updated
- 14 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Grant JE, Odlaug BL, Black DW, Fong T, Davtian M, Chipkin R, Kim SW. A single-blind study of 'as-needed' ecopipam for gambling disorder. Ann Clin Psychiatry. 2014 Aug;26(3):179-86.
PubMed 25166480
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ecopipam Treatment of Pathological Gambling
- ClinicalTrials.gov ID
- NCT01215357
- Acronym / sponsor ID
- PSY201
- Conditions
- Pathological Gambling
- Keywords
- Pathological Gambling, ecopipam, Dopamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Emalex Biosciences Inc.Industry (pharma, biotech, devices)
- Collaborators
- Psyadon Pharma
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 12 Feb 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to test the hypothesis that ecopipam is able to reduce urges to gamble in patients diagnosed with Pathological Gambling.
Detailed description
The purpose of this study is to determine if ecopipam is able to stop urges to gamble in patients diagnosed with Pathological Gambling. Nerves communicate with each other by releasing chemicals called "neurotransmitters". One of these neurotransmitters in the brain is called "dopamine". After dopamine is released by the nerve it "talks" to other nerves by interacting with receptors that are unique to that neurotransmitter. Ecopipam is a drug that selectively blocks one family of dopamine receptors. Some scientists believe that the urge to gamble is related to having too much dopamine in the brain. By blocking the receptors that dopamine uses, ecopipam may be able to relieve the urge to gamble.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ecopipam | Experimental | Drug: EcopipamEcopipam is a selective antagonist of one the classes of dopamine receptor. |
| Placebo | Placebo comparator | Drug: EcopipamPlacebo given first week of the study. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must be diagnosed with Pathological Gambling according to DSMIV criteria
- Subject must have at least 2 episodes of gambling behavior within the previous 2 weeks before screening
- Subject must have gambling urges of at least moderate intensity
Key exclusion criteria (8 listed)
- Subjects must not have unstable medical illness or clinically significant abnormalities on lab tests, ECG, or physical exam
- Subjects with major depressive episode within the last 2 years
- Subjects with a history of attempted suicide
- Subjects with first degree relative with major depressive episode that resulted in hospitalization, attempted or completed suicide
- Subjects with a history of epilepsy or seizures
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 |
|---|---|---|
| EcopipamAlso: PSYRX101, SCH 3916650mg tablets | Drug | Ecopipam, Placebo |
Primary outcome
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling
Time frame: Baseline and 6 weeks
This scale assesses the severity of gambling urges and gambling behaviors. The study anticipates that there will be a reduction in either or both of these assessments. The range is from a minimum of 0 to a maximum of 40, where zero means no gambling urges occurred.
3 secondary outcomes
Type, Frequency and Severity of Side Effects
Time frame: 6 weeks
Statistically Significant Changes in the Gambling Symptom Assessment Scale
Time frame: 6 weeks
Effects on the Clinical Global Impression
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25166480Grant JE, Odlaug BL, Black DW, Fong T, Davtian M, Chipkin R, Kim SW. A single-blind study of 'as-needed' ecopipam for gambling disorder. Ann Clin Psychiatry. 2014 Aug;26(3):179-86.
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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.
Jon Grant, MD principal investigator
Univ. of Minnesota
Donald Black, MD principal investigator
Iowa University
Timothy Fong, MD principal investigator
University of California, Los Angeles
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ecopipam in people with Pathological Gambling, run by Emalex Biosciences Inc. at 4 sites 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 3 inclusion and 8 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 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Statistically Significant (p<0.05) Decrease From Baseline in Yale Brown Obsessive Compulsive Scale Modified for Pathological Gambling (time frame: Baseline and 6 weeks). 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 NCT01215357, 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 14 May 2024.