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Substance AbusePhase 4NCT00203528

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

A Phase 4 study testing divalproex sodium ER and risperidone in people with Substance Abuse and Bipolar Depression, run by Tuscaloosa Research & Education Advancement Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 19 to 65 years
Conditions the study is for
Substance Abuse, Bipolar Depression
What is being tested?
divalproex sodium ER and risperidone
How many people
30 participants
Where
1 siteUnited States
Study dates
Jan 2004to Feb 2007
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 19 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Tuscaloosa Research & Education Advancement Corporation

    Tuscaloosa, Alabama, 35404

Other trials in United States

About this study

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

Read the 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.

Being tested
divalproex sodium ER, risperidone
Keywords
divalproex sodium, risperidone, dual diagnosis, substance use, bipolar
Medical subject headings
Substance-Related Disorders, Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJan 2004
  3. Study completionFeb 2007

Resources

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
Single group
Masking
Double blind
Enrolment
30 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00203528
Sponsor's protocol ID
TREAC Dual Diagnosis Study
Other IDs
TREAC Dual Diagnosis Study
Status last verified
Mar 2007
First submitted
12 Sep 2005
Last updated
19 Mar 2007
Results posted
No
Data monitoring committee
No

Publications

  • Le Fauve CE, Litten RZ, Randall CL, Moak DH, Salloum IM, Green AI. Pharmacological treatment of alcohol abuse/dependence with psychiatric comorbidity. Alcohol Clin Exp Res. 2004 Feb;28(2):302-12. doi: 10.1097/01.alc.0000113413.37910.d7.

    PubMed 15112938

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing divalproex sodium ER and risperidone in people with Substance Abuse and Bipolar Depression, run by Tuscaloosa Research & Education Advancement Corporation 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 7 inclusion and 17 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 19 Mar 2007. 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. 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?

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.. 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 NCT00203528, 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 19 Mar 2007.

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