Bipolar DisorderPhase 3NCT00194116
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
A Phase 3 study testing Divalproex Sodium ER in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an… Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Divalproex Sodium ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Feb 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Subject must give consent to participate in the study and sign and date the IRB approved written informed consent form prior to the initiation of any study procedures
- Subject must be between the ages of 18 and 70
- Subject must have a diagnosis of bipolar I or II.
- Subject must be currently depressed as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
- Subject must have a baseline Montgomery-Asberg Depression Scale (MADRS) score of >19 and Young Mania Rating Scale (YMRS) score of <12
- Women of childbearing potential must be nonpregnant/nonlactating and using adequate contraception if sexually active
- Subject must not be using any concomitant psychotropic medications during the acute phase except prn benzodiazepines
Who cannot join
- Subjects lacks the capacity to provide informed consent
- Subject has currently or previously used divalproex or Dvpx-ER
- Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
- Subject has any alcohol, cocaine, or cannabis dependence within 3 months of study entry
- Subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or MMDA abuse within 3 months of study entry
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals of Cleveland
Cleveland, Ohio, 44106
About this study
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.
- Conditions
- Bipolar Disorder
- Being tested
- Divalproex Sodium ER, Placebo
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium ERDrug
Also called Depakote ER
Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
PlaceboDrug
. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher.
| Study group | Role | What they receive |
|---|---|---|
| Divalproex Sodium ER | Experimental | Not described Receives: Drug: Divalproex Sodium ER |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
Measured: Acute phase (week0-week6)
Secondary outcomes (6)
Change in Young Mania Rating Scale (YMRS) Total Score
YMRS Scores range from 0 to 60 where higher scores are indicative of more mania.
Measured: Acute phase (week0-week6)
Change in General Behavior Inventory (GBI) Depression Scale Score
GBI Depression Scale Scores range from 46-184, where higher scores are indicative of more depression.
Measured: Acute phase (week0-week6)
Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score
GBI Hypomanic/Biphasic Scale scores range from 28-112, where higher scores are indicative of more hypomanic/manic symptoms.
Measured: Acute phase (week0-week6)
Change in Short Form Health Survey (SF-36) Physical Component Summary Score
SF-36 Physical Component Summary scores range from 0-100, with a higher score indicating better physical health.
Measured: Acute phase (week0-week6)
Change in Short Form Health Survey (SF-36) Mental Component Summary Score
SF-36 Mental Component Summary scores range from 0-100, with a higher score indicating better mental health.
Measured: Acute phase (week0-week6)
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
HAMA Scores range from 0 to 56 where higher scores are indicative of more anxiety.
Measured: Acute phase (week0-week6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionOct 2007
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott
- Responsible party
- Principal investigator, Keming Gao, University Hospitals Cleveland Medical Center
- Investigators
- Keming Gao, MD, PhD, Principal investigator, Case Western Reserve University / University Hospitals of Cleveland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00194116
- Sponsor's protocol ID
- UHHS 08-03-07
- Status last verified
- May 2019
- First submitted
- 13 Sep 2005
- Last updated
- 17 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Muzina DJ, Gao K, Kemp DE, Khalife S, Ganocy SJ, Chan PK, Serrano MB, Conroy CM, Calabrese JR. Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):813-9. doi: 10.4088/JCP.09m05570gre. Epub 2010 Aug 24.
PubMed 20816041
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
- ClinicalTrials.gov ID
- NCT00194116
- Acronym / sponsor ID
- UHHS 08-03-07
- Conditions
- Bipolar Disorder
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Collaborators
- Abbott
- Study start
- Sep 2004
- Primary completion
- Oct 2007 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Posted 17 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Divalproex Sodium ER | Experimental | Drug: Divalproex Sodium ER |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Subject must give consent to participate in the study and sign and date the IRB approved written informed consent form prior to the initiation of any study procedures
- Subject must be between the ages of 18 and 70
- Subject must have a diagnosis of bipolar I or II.
- Subject must be currently depressed as confirmed by the Mini-International Neuropsychiatric Interview (MINI)
- Subject must have a baseline Montgomery-Asberg Depression Scale (MADRS) score of >19 and Young Mania Rating Scale (YMRS) score of <12
Key exclusion criteria (5 listed)
- Subjects lacks the capacity to provide informed consent
- Subject has currently or previously used divalproex or Dvpx-ER
- Subject is a serious suicide risk or has medically unstable conditions as judged by the investigators
- Subject has any alcohol, cocaine, or cannabis dependence within 3 months of study entry
- Subject has any cocaine, hallucinogens, opiates, crystal methamphetamine, or MMDA abuse within 3 months of study entry
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 Sodium ERAlso: Depakote ERTablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. | Drug | Divalproex Sodium ER |
| Placebo. Tablets will be available in 250mg and 500mg strengths. Divalproex will be titrated to a minimum blood level of 50 mg/L. However, the investigators will titrate divalproex to the maximum tolerable dose with an expected average dose of 2000mg per day. By dosing in this manner, all subjects will have a minimum blood level of 50 mg/L, but the mean level is likely to be considerably higher. | Drug | Placebo |
Primary outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Time frame: Acute phase (week0-week6)
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
6 secondary outcomes
Change in Young Mania Rating Scale (YMRS) Total Score
Time frame: Acute phase (week0-week6)
Change in General Behavior Inventory (GBI) Depression Scale Score
Time frame: Acute phase (week0-week6)
Change in General Behavior Inventory (GBI) Hypomanic/Biphasic Scale Score
Time frame: Acute phase (week0-week6)
Change in Short Form Health Survey (SF-36) Physical Component Summary Score
Time frame: Acute phase (week0-week6)
Change in Short Form Health Survey (SF-36) Mental Component Summary Score
Time frame: Acute phase (week0-week6)
Change in Hamilton Anxiety Rating Scale (HAMA) Total Score
Time frame: Acute phase (week0-week6)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 20816041Muzina DJ, Gao K, Kemp DE, Khalife S, Ganocy SJ, Chan PK, Serrano MB, Conroy CM, Calabrese JR. Acute efficacy of divalproex sodium versus placebo in mood stabilizer-naive bipolar I or II depression: a double-blind, randomized, placebo-controlled trial. J Clin Psychiatry. 2011 Jun;72(6):813-9. doi: 10.4088/JCP.09m05570gre. Epub 2010 Aug 24.
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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.
Keming Gao, MD, PhD principal investigator
Case Western Reserve University / University Hospitals of Cleveland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Divalproex Sodium ER in people with Bipolar Disorder, run by University Hospitals Cleveland Medical Center 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 5 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 17 Jul 2019. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score (time frame: Acute phase (week0-week6)). 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 NCT00194116, 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 17 Jul 2019.