Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder

March 16, 2007 updated by: Tuscaloosa Research & Education Advancement Corporation
The primary objective is to evaluate the safety and efficacy of divalproex extended release (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients will be screened up to seven days at which time the following assessments will be completed: the Structured Clinical Interview for DSM-IV (SCID), general medical history, psychiatric history, physical examination, physicians assessment, and laboratory tests. Patients who are on mood stabilizers and oral neuroleptics prior to study enrollment and are not responding fully to these medications will be tapered off of the medication for a washout period of 48 hours. After the completion of screening, only patients who are determined to be eligible for the study will be randomized to study medication (divalproex or risperidone) in a 1:1 double-blind fashion. Scheduled study visits will occur every two weeks for a total of 12 weeks. Assessments for each visit, from the baseline visit to the week 12 visit are as follows: the Clinical Global Impression (CGI), Global Assessment of Functioning (GAF), Alcohol and Drug Use Inventory, clinician alcohol and drug use scales, self report scales, adverse events, vital signs and weight, concomitant medications, urine drug screen, and study medication accountability. Designated research staff will complete assessments weekly. Investigators will be blinded to laboratory tests completed at week 2, 4, and 12 visits. Patients randomized to Depakote ER will begin 500mg BID on day of randomization and remain on this dose for 5 days, then on day 6 increase to 20mg/kg to achieve valproic acid levels of 80-100 (blinded laboratory reporting). Patients randomized to risperidone, initially start with 2mg QD with an increase to 4mg at day 5 and increase (as tolerated or required) up to 6mg/d.

Study Type

Interventional

Enrollment

30

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

  • United States
    • Alabama
      • Tuscaloosa, Alabama, United States, 35404
        • Tuscaloosa Research & Education Advancement Corporation

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

19 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written informed consent for trial participation.
  • Male or female patients, ages 19-65.
  • Patients must meet DSM-IV criteria for bipolar I or bipolar II disorder (any phase of illness) and concurrent substance use disorder (alcohol or illicit drug abuse or dependence).
  • Female patients of childbearing potential must be using a reliable method of contraception. Reliable methods of contraception include hormonal contraceptives (oral contraceptive or long-term injectable or implantable hormonal contraceptive), barrier methods (e.g., condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation.
  • Female patients of child-bearing potential must have a negative urine pregnancy test at screening.
  • Patients must not have other serious unstable illnesses and must be otherwise physically stable on the basis of a physical exam, medical history, and the results of blood biochemistry, hematology tests, and a urinalysis.
  • Patients must complete at least a 48-hour wash screening/washout period for mood stabilizers and oral neuroleptics.The wash screening/washout period may be completed as an inpatient. If so patient may remain an inpatient as long as necessary. Should the patient become discharged he or she must be able to continue in the study as an outpatient.

Exclusion Criteria:

  • Patients with a current DSM-IV diagnosis of schizophrenia or schizoaffective disorder.
  • Patients who are legally incompetent
  • Receiving any other psychotropic medication within 48 hours of randomization, excluding trazodone for insomnia.
  • Patients with Axis I or Axis II diagnosis that in the investigator's opinion, would interfere with compliance or confound interpretation of the results.
  • Patients with CNS neoplasm, uncontrolled metabolic, endocrine, demyelinating or progressive neurological disorder, pancreatitis, or urea cycle disorder.
  • Patients with a blood chemistries ALT and/or AST value(s) greater than or equal to three times the upper limit of normal prior to randomization.
  • Patients with a history of a chronic or acute medical disorder that, in the opinion of the investigator, would confound interpretation of the study results.
  • Patients with a medical condition that requires the continuous use of medication that would interfere with the evaluation of safety or efficacy of divalproex ER or risperidone. Patients receiving beta-blockers are excluded unless the dose has been stable for greater than 6 months.
  • Patients who have received depot neuroleptic medication within one inter-injection interval of randomization. Patients on depot medications may be included if they are randomized no earlier than the time of their next scheduled depot injection.
  • Patients who exhibits signs of drug or alcohol withdrawal at the time of randomization.
  • Patients that require the use of naltrexone or disulfiram during the study.
  • Patients with a history of previous severe intolerance, idiosyncratic reaction or allergies related to valproate or risperidone.
  • Patients with a history of failed treatment on adequate valproate or risperidone therapy for bipolar disorder in the opinion of the investigator.
  • Patients who have taken Divalproex DR, Divalproex ER, or risperidone regularly over the 30 days prior to screening/washout. If patients have taken divalproex (either DR or ER) at all in the 30 days prior to screening/washout, a serum valproate level must be done at the time of screening and found to be below the minimum quantifiable limit.
  • Women who are pregnant or intends to become pregnant.
  • Patient with a platelet count at screening <100,000/mL.
  • Patients with serious violent, homicidal, or suicidal ideation.

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: SINGLE_GROUP
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary objective is to evaluate the safety and efficacy of divalproex extended release (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use disorder.

Collaborators and Investigators

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

Sponsor

Tuscaloosa Research & Education Advancement Corporation

Collaborators

Abbott

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2004

Study Completion (ACTUAL)

February 1, 2007

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 20, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 19, 2007

Last Update Submitted That Met QC Criteria

March 16, 2007

Last Verified

March 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TREAC Dual Diagnosis Study

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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