Quetiapine for Bipolar Disorder and Alcohol Dependence

The purpose of this study is to find out whether an investigational drug called quetiapine can treat bipolar disorder, improve mood and reduce alcohol use and craving.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The primary aim in the study is to determine if quetiapine treatment is associated with greater reduction in alcohol use than placebo in outpatients with bipolar disorder and alcohol dependence. We will also examine if quetiapine treatment is associated with greater reduction in alcohol craving than placebo in outpatients with bipolar disorder and alcohol dependence and if quetiapine treatment is associated with greater improvement in depressive symptoms than placebo in outpatients with bipolar disorder and alcohol dependence.

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Texas
      • Dallas, Texas, United States, 75235
        • Psychoneuroendocrine Research Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Outpatients with a diagnosis of bipolar I or II disorder, depressed or mixed phase on the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID) and confirmed by interview with PI or co-I.
  • Current diagnosis of alcohol dependence.
  • Alcohol use (by self-report) of at least 15 drinks in the 7 days prior to baseline.
  • Currently taking a mood stabilizer defined as lithium, divalproex/valproic acid, oxcarbazepine, or lamotrigine at a stable dose for > 14 days.
  • Men and women age 18-65 years old.
  • English or Spanish speaking.

Exclusion Criteria:

  • Bipolar disorders other than bipolar I or II (e.g., not otherwise specified or cyclothymic disorders) based on the SCID and confirmed through clinical assessment by PI or co-I.
  • Baseline Young Mania Rating Scale (YMRS) score > 35 or Hamilton Depression Rating Scale (HRSD) 17 score > 35.
  • Current clinically significant psychotic features (hallucinations, delusions, disorganized thought processes).
  • Evidence of clinically significant alcohol withdrawal symptoms defined as a Clinical Institute Withdrawal Assessment (CIWA-AR) score of > 8.
  • History of hepatic cirrhosis or baseline AST or ALT > 3X upper limit of normal or other clinically significant findings on physical or laboratory examination.
  • Mental retardation or other severe cognitive impairment.
  • Prison or jail inmates.
  • Pregnant or nursing women or women of childbearing age who will not use oral contraceptives, abstinence, or other acceptable methods of birth control during the study.
  • Antipsychotic therapy within 14 days prior to randomization.
  • Current carbamazepine or benzodiazepine therapy.
  • Current treatment with medications shown to reduce alcohol consumption (naltrexone, acamprosate, disulfiram, or topiramate) in large randomized, controlled trials.
  • Initiation of antidepressants or mood stabilizers or psychotherapy within past 2 weeks.
  • High risk for suicide, defined as any suicide attempts in the past 3 months or current suicidal ideation with plan and intent.
  • Intensive outpatient treatment for substance abuse (AA, NA meetings, or other 12-step programs or weekly psychotherapy that started at least 14 days prior to randomization will be allowed).
  • Current treatment with ketoconazole, itraconazole, erythromycin, or nefazodone.
  • Severe or life-threatening medical condition (e.g., congestive heart failure, terminal cancer) or laboratory or physical examination findings consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes).
  • Diabetes mellitus by history or suspected from baseline blood sugar.
  • History of cataracts or suspected cataracts on ophthalmic exam
  • History of seizure disorder of any etiology; if a subject develops a seizure episode, s/he will be discontinued from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.
Inactive ingredient matching the active medication in appearance.
Other Names:
  • Sugar-pill
ACTIVE_COMPARATOR: Quetiapine
This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.
Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder.
Other Names:
  • Seroquel
  • Ketipinor
  • Xeroquel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Number of Standard Drinks/Day Will Serve as the Primary Outcome Measure.
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inventory of Depressive Symptomatology-Self Report (IDS-SR)
Time Frame: 12 weeks

IDS-SR is a self reported 30 item assessment to diagnose a major depressive episode.

Score:

Minimum: 0 Maximum: 84 Lower score associated with better outcome

12 weeks
Young Mania Rating Scale (YMRS)
Time Frame: 12 weeks

This is an 11-item, observer rated measure of the severity of manic symptoms on a 5 point scale. The total score indicates overall severity of mania with a minimum of zero (indicating normalcy) and a maximum of 60 (indicating very severe).

Score:

Minimum: 0 Maximum: 60 Lower score associated with better outcome

12 weeks
Percent of Heavy Drinking Days
Time Frame: 12 weeks
12 weeks
Gamma-glutamyltransferase (GGT)
Time Frame: 12 weeks
GGT is a liver enzyme measurement (IU/I)
12 weeks
Aspartate Aminotransferase (AST)
Time Frame: 12 weeks
AST is a liver enzyme measurement (IU/I)
12 weeks
Alanine Aminotransferase (ALT)
Time Frame: 12 weeks
ALT is a liver enzyme measurement (IU/I).
12 weeks
Hamilton Rating Scale for Depression (HRSD)
Time Frame: 12 weeks

The assessment is a clinician administered rating of depression with 17 questions. The total score is indicates level of depression within the following ranges: none (0-5), mild (6-10), moderate (11-15), severe (16-20), and very severe (21+).

Scale:

Minimum: 0 Maximum: 50 Lower score associated with better outcome

12 weeks
Penn Alcohol Craving Scale (PACS)
Time Frame: 12 weeks

The PACS is a five-item self-administered instrument for assessing craving, frequency, intensity, and duration of thoughts about drinking are assessed along with ability to resist drinking

Score:

Minimum: 0 Maximum: 30 Lower score associated with better outcome.

12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: E. Sherwood Brown, MD PhD, UT Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (ACTUAL)

July 1, 2011

Study Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

April 4, 2007

First Submitted That Met QC Criteria

April 5, 2007

First Posted (ESTIMATE)

April 6, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

April 5, 2016

Last Update Submitted That Met QC Criteria

April 1, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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