Bipolar DisorderPhase 3NCT00060905
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
A Phase 3 study testing Divalproex Sodium (Depakote ER) in people with Bipolar Disorder, run by Abbott at 18 sites in United States.
Trial summary
The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Divalproex Sodium (Depakote ER)
- How many people
- 370 participants
- Where
- 18 sitesUnited States
- Study dates
- Jan 2003to not given
- Phase
- Phase 3
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18
- Hospitalized no more than 7 days at time of Screening or in process of being admitted
- History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement
Who cannot join
- History of schizophrenia or schizoaffective disorder
- Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
- Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
- Had first manic episode after age 60
- Has ever taken clozapine
Show all 12Show fewer
- Has received depot neuroleptic medication within one inter-injection interval of first dose of study drug
- Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
- History of active alcohol or substance dependence within past 3 months.
- History of failed treatment on adequate valproate therapy for bipolar disorder
- Has taken Depakote (DR or ER) regularly over the last 30 days
- Has serious violent, homicidal, or suicidal ideation
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Pioneer Research
Baltimore, Michigan, 48047
McLean Hospital
Belmont, Massachusetts, 02478
Comprehensive Neuroscience of SCA
Cerritos, California, 90703
Steven A. Glass, MD
Clementon, New Jersey, 08021
MetroHealth Medical Center
Cleveland, Ohio, 44109
CNS of Northern Virginia
Falls Church, Virginia, 22041
Mark Lerman, MD
Hoffman Estates, Illinois, 60194
The Holliswood Hospital
Holliswood, New York, 11423
UT Mental Sciences Institute
Houston, Texas, 77030
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Louisville Bipolar Research Program
Louisville, Kentucky, 40202
VAMC
Milwaukee, Wisconsin, 53295
NYU School of Medicine - Bellevue
New York, New York, 10016
Centers for Behavioral Health, LLC
Rockville, Maryland, 20850
San Antonio State Hospital
San Antonio, Texas, 78223
Brentwood Research Inst.
Shreveport, Louisiana, 71101
AVI Clinical Research
Torrance, California, 90505
Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
- Conditions
- Bipolar Disorder
- Being tested
- Divalproex Sodium (Depakote ER)
- Keywords
- Bipolar Disorder (manic or mixed type)
- Medical subject headings
- Bipolar Disorder, Mania
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Divalproex Sodium (Depakote ER)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
Secondary outcomes (2)
Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2003 (estimated)
- Study startJan 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 370 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information - Abbott, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00060905
- Sponsor's protocol ID
- M02-540
- Status last verified
- Aug 2006
- First submitted
- 15 May 2003
- Last updated
- 4 Aug 2006
- Results posted
- No
Publications
Hirschfeld RM, Bowden CL, Vigna NV, Wozniak P, Collins M. A randomized, placebo-controlled, multicenter study of divalproex sodium extended-release in the acute treatment of mania. J Clin Psychiatry. 2010 Apr;71(4):426-32. doi: 10.4088/JCP.08m04960yel. Epub 2010 Mar 9.
PubMed 20361904Bowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10. doi: 10.4088/jcp.v67n1003.
PubMed 17107240
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00060905
- Acronym / sponsor ID
- M02-540
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder (manic or mixed type)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2003
- First posted
- 16 May 2003 (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 determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.
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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Current primary diagnosis of bipolar I disorder, mania or mixed type
- Acute exacerbation of mania associated with bipolar disorder as defined by Mania Rating Scale score >= 18
- Hospitalized no more than 7 days at time of Screening or in process of being admitted
- History of at least one prior manic or mixed episode within past 3 years, exclusive of the current episode. Prior manic or mixed episode must be separated from current episode by at least 2 months of sustained improvement
Key exclusion criteria (12 listed)
- History of schizophrenia or schizoaffective disorder
- Axis I (e.g., anxiety disorder), or Axis II (e.g., personality disorder) that would interfere with compliance or confound interpretation of study results
- Current manic or mixed episode is drug-induced or secondary to a medical disorder (e.g., AIDS, corticosteroids)
- Current manic or mixed episode is believed to be caused by antidepressant use (i.e., antidepressant-induced mania)
- Had first manic episode after age 60
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 (Depakote ER) | Drug | – |
Primary outcome
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.
2 secondary outcomes
Change from baseline to the final evaluation for the Manic Syndrome Scale (MSS), Behavior and Ideation Scale (BIS),
BPRS (and published subscales), Global Assessment Scale (GAS), the Nursing Observation Scale for Inpatient Evaluation (NOSIE), and Burden Questionnaire, as well as the percentage of subjects with at least 50% improvement on the MRS.
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 4 Aug 2006.
- Derived from this study: PubMed 20361904Hirschfeld RM, Bowden CL, Vigna NV, Wozniak P, Collins M. A randomized, placebo-controlled, multicenter study of divalproex sodium extended-release in the acute treatment of mania. J Clin Psychiatry. 2010 Apr;71(4):426-32. doi: 10.4088/JCP.08m04960yel. Epub 2010 Mar 9.
- Derived from this study: PubMed 17107240Bowden CL, Swann AC, Calabrese JR, Rubenfaer LM, Wozniak PJ, Collins MA, Abi-Saab W, Saltarelli M; Depakote ER Mania Study Group. A randomized, placebo-controlled, multicenter study of divalproex sodium extended release in the treatment of acute mania. J Clin Psychiatry. 2006 Oct;67(10):1501-10. doi: 10.4088/jcp.v67n1003.
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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.
Global Medical Information - Abbott study director
Abbott
18 sites 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 (Depakote ER) in people with Bipolar Disorder, run by Abbott at 18 sites 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 4 inclusion and 12 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 4 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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 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?
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?
Change from baseline to the final evaluation for the MRS from the SADS-C for the intent-to-treat dataset.. 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 NCT00060905, which also lists 2 linked publications.
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 4 Aug 2006.