Bipolar DisorderPhase 4NCT00208195
Depakote ER Therapy for Mania Comorbid With Substance Abuse
A Phase 4 study testing Divalproex ER in people with Bipolar Disorder and Mania, run by Creighton University at 1 site in United States.
Trial summary
The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Mania, Substance Abuse
- What is being tested?
- Divalproex ER
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2004to Nov 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 19 - 65.
- Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
- Comorbid diagnoses of anxiety and/or personality disorders are permitted.
- Ability to provide signed informed consent.
- Stable general medical health.
- Ability to attend outpatient research clinic.
Who cannot join
- Dangerous to self or others.
- Pregnancy, inability or unwillingness to use approved methods of birth control.
- Inability or unwillingness to provide signed informed consent.
- Diagnosis of schizophrenia, major depressive disorder.
- Inability to attend outpatient research clinic.
- Medical conditions, which would preclude use of Depakote.
- Need for ongoing treatment with medication other than Depakote ER, such as antipsychotic medication.
- Medical instability defined as likelihood of needing to change prescription medication during the course of the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Creighton University Psychiatry Research Center
Omaha, Nebraska, 68131
About this study
The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.
Read the detailed description
This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.
- Conditions
- Bipolar Disorder, Mania, Substance Abuse, Substance Dependence
- Being tested
- Divalproex ER
- Keywords
- Bipolar Disorder, Mania, Substance Abuse, Substance Dependence, Comorbid
- Medical subject headings
- Bipolar Disorder, Mania, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex ERDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
Measured: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months
Secondary outcomes (1)
The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).
Measured: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2004
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Creighton University
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Investigators
- Pirzada Sattar, MD, Principal investigator, Creighton University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00208195
- Sponsor's protocol ID
- 03-13258
- Status last verified
- Dec 2007
- First submitted
- 14 Sep 2005
- Last updated
- 14 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depakote ER Therapy for Mania Comorbid With Substance Abuse
- ClinicalTrials.gov ID
- NCT00208195
- Acronym / sponsor ID
- 03-13258
- Conditions
- Bipolar Disorder, Mania, Substance Abuse, Substance Dependence
- Keywords
- Bipolar Disorder, Mania, Substance Abuse, Substance Dependence, Comorbid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Creighton UniversityUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Mar 2004
- Study completion
- Nov 2007 (actual)
- First posted
- 21 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 purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.
Detailed description
This study will be performed in male and female subjects with a diagnosis of bipolar disorder in the manic phase of the illness who also have a comorbid diagnosis of substance abuse. This population is selected so the efficacy of Depakote ER in this population can be tested.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ages 19 - 65.
- Diagnosis of mania with comorbid substance confirmed by Structured Clinical Interview for DSM-IV.
- Comorbid diagnoses of anxiety and/or personality disorders are permitted.
- Ability to provide signed informed consent.
- Stable general medical health.
Key exclusion criteria (8 listed)
- Dangerous to self or others.
- Pregnancy, inability or unwillingness to use approved methods of birth control.
- Inability or unwillingness to provide signed informed consent.
- Diagnosis of schizophrenia, major depressive disorder.
- Inability to attend outpatient research clinic.
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 |
|---|---|---|
| Divalproex ER | Drug | – |
Primary outcome
The primary outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB.
Time frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months
1 secondary outcome
The Addiction Severity Index (ASI), Penn Alcohol Craving Scale, and Clinical Global Impression (CGI).
Time frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months, for a total study duration of 6 months
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 14 Dec 2007.
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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.
Pirzada Sattar, MD principal investigator
Creighton University
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 Divalproex ER in people with Bipolar Disorder and Mania, run by Creighton University 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 6 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 Dec 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 outcome measures will consist of the total score on the YMRS, and the number of days abstinent from substances of abuse with the TLFB. (time frame: Patients will be evaluated on a weekly basis for the first month, then every 2 weeks for the next 2 months, then monthly for the next 3 months for a total study duration of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2007.