Bipolar DisorderPhase 4NCT00223249
Quetiapine in Patients With Bipolar and Alcohol Abuse/Dependence
A Phase 4 study testing Quetiapine in people with Bipolar Disorder and Alcohol Abuse/Dependence, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bipolar Disorder, Alcohol Abuse/Dependence
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Aug 2004
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bipolar I or II
- Ages 18-70
Who cannot join
- Life threatening medical condition causing participation in the study hazardous
- Alcohol abuse within the past 2 weeks
- History of cataracts or likely cataracts on baseline eye exam
- History of hepatic cirrhosis or AST or ALT more than three times normal limit
- Current active suicidal or homicidal ideation
- History of allergic reaction, poor response or intolerable side effects to quetiapine
- Antipsychotic use within 7 days of beginning quetiapine therapy
- Mental retardation, dementia or other severe cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
The UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390-8843
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.
The abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.
Read the detailed description
Experimental: After obtaining informed consent, 100 patients with bipolar I, or II disorders and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be enrolled. from referral sources in the community we have developed over the past 3 years. A medical history and physical examination, including an eye exam with an ophthalmoscope, will also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline labs including a liver panel and CBC will be obtained. Women of child-bearing potential will be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2 weeks, days used in the past two weeks, and days of heavy use will be obtained as will a urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the study. Side-effects will be assessed with a general side effects scale, the Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be randomized and receive quetiapine or identical appearing placebo add-on therapy in a double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation with the above outcome measures and for upward titration of study drug. All subjects will be given the option of receiving open-label quetiapine for an additional 4 weeks (with continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the study or discontinuing medication.
- Conditions
- Bipolar Disorder, Alcohol Abuse/Dependence
- Being tested
- Quetiapine
- Medical subject headings
- Bipolar Disorder, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Active comparator | Quetiapine Receives: Drug: Quetiapine |
| Placebo | Placebo comparator | Inactive ingredient matching the active medication in appearance Receives: Drug: Quetiapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Standard Drinks
Measured: Weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionAug 2004
- Study completionAug 2004
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 Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- E. Sherwood Brown, Ph.D., M.D., Principal investigator, The UT Southwestern Medical Center at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00223249
- Sponsor's protocol ID
- IRUSQUET0233
- Status last verified
- Apr 2016
- First submitted
- 15 Sep 2005
- Last updated
- 4 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Brown ES, Garza M, Carmody TJ. A randomized, double-blind, placebo-controlled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders. J Clin Psychiatry. 2008 May;69(5):701-5. doi: 10.4088/jcp.v69n0502.
PubMed 18312058
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Alcohol Abuse/ Dependence.
- ClinicalTrials.gov ID
- NCT00223249
- Acronym / sponsor ID
- IRUSQUET0233
- Conditions
- Bipolar Disorder, Alcohol Abuse/Dependence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004 (actual)
- First posted
- 22 Sep 2005 (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 abuse of alcohol is especially common in people with bipolar disorder. However, very little is known about the pharmacotherapy of people with both bipolar disorder and alcohol abuse/dependence. The purpose of this study is to determine if alcohol use and cravings are decreased with quetiapine add-on therapy compared to placebo and to determine if quetiapine add-on therapy is associated with greater improvement in mood, impulsivity, functioning and decreased alcohol use than placebo.
Detailed description
Experimental: After obtaining informed consent, 100 patients with bipolar I, or II disorders and alcohol abuse/dependence confirmed by a structured clinical interview (SCID) will be enrolled. from referral sources in the community we have developed over the past 3 years. A medical history and physical examination, including an eye exam with an ophthalmoscope, will also be performed at baseline to rule out serious medical illnesses and cataracts. Baseline labs including a liver panel and CBC will be obtained. Women of child-bearing potential will be given a urine pregnancy test. Baseline measures of psychiatric symptoms will be assessed with the HRSD, YMRS, and Barratt Impulsiveness Scale. Alcohol cravings will be assessed with the Obsessive Compulsive Drinking Scale (OCDS). Alcohol use including number of drinks/2 weeks, days used in the past two weeks, and days of heavy use will be obtained as will a urine drug/alcohol screen. Alcohol use and cravings will also be recorded throughout the study. Side-effects will be assessed with a general side effects scale, the Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Scale (SAS), and Barnes Akathesia Rating Scale (BARS). GGT levels will also be repeated at weeks 6 and 12. The subjects will be randomized and receive quetiapine or identical appearing placebo add-on therapy in a double-blind fashion for 12 weeks. Subjects will return every two weeks for reevaluation with the above outcome measures and for upward titration of study drug. All subjects will be given the option of receiving open-label quetiapine for an additional 4 weeks (with continuing assessment of mood and alcohol use/cravings every 2 weeks) at the end of the study or discontinuing medication.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Active comparator | Drug: QuetiapineQuetiapine |
| Placebo | Placebo comparator | Drug: QuetiapineInactive ingredient matching the active medication in appearance |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Bipolar I or II
- Ages 18-70
Key exclusion criteria (8 listed)
- Life threatening medical condition causing participation in the study hazardous
- Alcohol abuse within the past 2 weeks
- History of cataracts or likely cataracts on baseline eye exam
- History of hepatic cirrhosis or AST or ALT more than three times normal limit
- Current active suicidal or homicidal ideation
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 |
|---|---|---|
| Quetiapine | Drug | Placebo, Quetiapine |
Primary outcome
Number of Standard Drinks
Time frame: Weekly
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 4 Apr 2016.
- Derived from this study: PubMed 18312058Brown ES, Garza M, Carmody TJ. A randomized, double-blind, placebo-controlled add-on trial of quetiapine in outpatients with bipolar disorder and alcohol use disorders. J Clin Psychiatry. 2008 May;69(5):701-5. doi: 10.4088/jcp.v69n0502.
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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.
E. Sherwood Brown, Ph.D., M.D. principal investigator
The UT Southwestern Medical Center at Dallas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine in people with Bipolar Disorder and Alcohol Abuse/Dependence, run by University of Texas Southwestern Medical Center 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 2 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 4 Apr 2016. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of Standard Drinks (time frame: Weekly). 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 NCT00223249, 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 4 Apr 2016.