Bipolar DisorderPhase 4NCT00226343
Depakote-ER for Depressive and Bipolar Depression
A Phase 4 study testing Depakote-ER in people with Bipolar Disorder, run by Cambridge Health Alliance.
Trial summary
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Depakote-ER
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Aug 2006
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics
Who cannot join
- Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
About this study
Official title: Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.
Read the detailed description
Study is 6 weeks long, with 7 clinical visits.
- Conditions
- Bipolar Disorder
- Being tested
- Depakote-ER
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Depakote-ERDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Depressive Symptom severity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionJan 2006
- Study completionAug 2006
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.
- 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
- Double blind
- Enrolment
- 25 participants
Sponsor and investigators
- Lead sponsor
- Cambridge Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Robert T Dunn, MD, PhD, Principal investigator, Cambridge Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226343
- Sponsor's protocol ID
- CHA-IRB-0007/07/03
- Status last verified
- Apr 2017
- First submitted
- 12 Sep 2005
- Last updated
- 18 Apr 2017
- Results posted
- No
- FDA-regulated device
- No
Publications
Ghaemi SN, Gilmer WS, Goldberg JF, Zablotsky B, Kemp DE, Kelley ME, Bauer AD, Fleck J, Filkowski MM, Stan VA, Dunn RT. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry. 2007 Dec;68(12):1840-4. doi: 10.4088/jcp.v68n1203.
PubMed 18162014
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study: Double-blind Placebo-controlled Trial of Depakote-ER for Depressive and Anxiety Symptoms in Non-refractory Bipolar Depression
- ClinicalTrials.gov ID
- NCT00226343
- Acronym / sponsor ID
- CHA-IRB-0007/07/03
- Conditions
- Bipolar Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants
- Lead sponsor
- Cambridge Health AllianceUniversity, hospital or other
- Collaborators
- Northwestern University
- Study start
- Aug 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 27 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.
Obtain information using a randomized treatment to assess the antidepressant and anxiolytic efficacy of divalproex vs. placebo for nonrefractory bipolar patients with major depressive episodes.
Detailed description
Study is 6 weeks long, with 7 clinical visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- DSM-IV diagnosis of bipolar disorder type I or II, non refractory, non-psychotic; females must be nonpregnant/nonlactating; sexually active females must use adequate contraception; MRS < 12; MADRS > 17; no other baseline mood stabilizing drugs, antidepressants or antipsychotics
Key exclusion criteria (1 listed)
- Active substance abuse or dependence in the past month; medically unstable condition; previously intolerance to valproate; past hepatitis B or C, or serious liver disease; serious suicidality
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 |
|---|---|---|
| Depakote-ER | Drug | – |
Primary outcome
Anxiety and Depressive Symptom severity
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 18 Apr 2017.
- Derived from this study: PubMed 18162014Ghaemi SN, Gilmer WS, Goldberg JF, Zablotsky B, Kemp DE, Kelley ME, Bauer AD, Fleck J, Filkowski MM, Stan VA, Dunn RT. Divalproex in the treatment of acute bipolar depression: a preliminary double-blind, randomized, placebo-controlled pilot study. J Clin Psychiatry. 2007 Dec;68(12):1840-4. doi: 10.4088/jcp.v68n1203.
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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.
Robert T Dunn, MD, PhD principal investigator
Cambridge Health Alliance
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Depakote-ER in people with Bipolar Disorder, run by Cambridge Health Alliance.
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 1 inclusion and 1 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 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Anxiety and Depressive Symptom severity. 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 NCT00226343, 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 18 Apr 2017.