Bipolar DisorderPhase 4NCT00071253
Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
A Phase 4 study testing Divalproex Sodium (Delayed-Release Tablets), Divalproex Sodium (Extended-Release Tablets) and Olanzapine in people with Bipolar Disorder, run by Abbott at 15 sites in United States.
Trial summary
The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness. 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 (Delayed-Release Tablets), Divalproex Sodium (Extended-Release Tablets) and Olanzapine
- Type of treatment
- Pill or oral medicine
- How many people
- 180 participants
- Where
- 15 sitesUnited States
- Study dates
- Jul 2003to not given
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV-TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID
- Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months
- Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable
- MRS total score < 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1)
- DSS score < 13 on two consecutive ratings, separated by at least five days (Screening and Day 1)
- CGI-S score < 3 on two consecutive ratings, separated by at least five days (Screening and Day 1)
- Serum valproate level > 45 mcg/mL, and a maximum allowable dose of Depakote of 3000 mg/day at Screening
- Olanzapine dose between 5 and 20 mg/day at Screening
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
- Has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than Depakote or olanzapine in the four months prior to randomization. Other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased
- Has first manic episode after age 60
- Has ever taken clozapine
- Has received depot neuroleptic medication within six months of randomization
Show all 9Show fewer
- Urine toxicology screen is positive for phencyclidine (PCP), opiates, cocaine or amphetamines
- History of active alcohol or substance abuse/dependence within 90 days prior to Screening
- Known history of non-response to either Depakote or olanzapine monotherapy for the treatment of bipolar disorder
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Behavioral and Medical Research, LLC
Anaheim, California, 92805
Rush Presbyterian - St. Luke's
Chicago, Illinois, 60612
Synergy Clinical Research
Chula Vista, California, 91910
University Hospital of Cleveland
Cleveland, Ohio, 44106
Clinical Trial Management
Fort Meyers, Florida, 33907
UTMB Dept. of Psychiatry
Galveston, Texas, 77555-0197
University of Mississippi Medical Center
Jackson, Mississippi, 39216
University of Louisville Outpatient Psychiatry
Louisville, Kentucky, 40202
R. Ranjan, MD & Associates, Inc.
Lyndhurst, Ohio, 44124
Zablocki VAMC
Milwaukee, Wisconsin, 53295
NYU School of Medicine
New York, New York, 10016
Lake Mead Hospital
North Las Vegas, Nevada, 89030
Segal Institute for Clinical Research
North Miami, Florida, 33161
IPS Research
Oklahoma City, Oklahoma, 73103
Creighton University Department of Psychiatry
Omaha, Nebraska, 68131
About this study
Official title: A Randomized, Double-Blind Study of Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
The purpose of this study is to assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.
- Conditions
- Bipolar Disorder
- Being tested
- Divalproex Sodium (Delayed-Release Tablets), Divalproex Sodium (Extended-Release Tablets), Olanzapine
- Keywords
- Bipolar Disorder - Mania
- 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 (Delayed-Release Tablets)Drug
Divalproex Sodium (Extended-Release Tablets)Drug
OlanzapineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-s
CGI-i
MRS
DSS
SADS-C
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2003 (estimated)
- Study startJul 2003
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Medical Information, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071253
- Sponsor's protocol ID
- M02-551
- Status last verified
- Aug 2006
- First submitted
- 16 Oct 2003
- Last updated
- 4 Aug 2006
- Results posted
- No
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
- A Randomized, Double-Blind Study of Depakote Monotherapy, Olanzapine Monotherapy, and Combination Therapy of Depakote Plus Olanzapine in Stable Subjects During the Maintenance Phase of Bipolar Illness
- ClinicalTrials.gov ID
- NCT00071253
- Acronym / sponsor ID
- M02-551
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder - Mania
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 180 participants
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- First posted
- 20 Oct 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 assess the efficacy and safety of continued combination therapy using Depakote plus olanzapine, vs. Depakote monotherapy and olanzapine monotherapy in stable subjects during the maintenance phase of bipolar illness.
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 (8 listed)
- DSM-IV-TR primary diagnosis of Bipolar I Disorder as confirmed by the SCID
- Outpatient receiving treatment with a combination of Depakote plus olanzapine for their bipolar illness and considered clinically stable (e.g., no more than minimal symptoms, no psychiatric hospitalizations, no increase in intensity of clinical interventions) for the preceding 4 months
- Identified at Screening a most bothersome side effect listed in the UKU which makes switching to monotherapy desirable
- MRS total score < 12 on two consecutive ratings, separated by at least 5 days (Screening and Day 1)
- DSS score < 13 on two consecutive ratings, separated by at least five days (Screening and Day 1)
Key exclusion criteria (9 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
- Has taken antipsychotics, mood stabilizers, or anticonvulsants (unless specifically for seizure control) other than Depakote or olanzapine in the four months prior to randomization. Other psychotropics (e.g., antidepressants, anxiolytics) with the exception of stimulants, that have been used routinely to maintain stability in the preceding four months may be continued, but not increased or decreased
- Has first manic episode after age 60
- Has ever taken clozapine
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 (Delayed-Release Tablets) | Drug | – |
| Divalproex Sodium (Extended-Release Tablets) | Drug | – |
| Olanzapine | Drug | – |
Primary outcome
CGI-s
CGI-i
MRS
DSS
SADS-C
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2006.
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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 study director
Abbott
15 sites 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 Sodium (Delayed-Release Tablets), Divalproex Sodium (Extended-Release Tablets) and Olanzapine in people with Bipolar Disorder, run by Abbott at 15 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 8 inclusion and 9 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: stopped early, 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 15 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 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 was stopped early. Results are not available in the source record.
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?
CGI-s. The study lists 5 primary outcomes in all. 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 4 Aug 2006.