Bipolar DisorderPhase 4NCT00183469
Maintenance Treatment of Bipolar Depression
A Phase 4 study testing Lamotrigine and Divalproex (DIV) ER in people with Bipolar Disorder and Depression, run by The University of Texas Health Science Center at San Antonio.
Trial summary
This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bipolar Disorder, Depression
- What is being tested?
- Lamotrigine and Divalproex (DIV) ER
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Apr 2009
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bipolar disorder I or II
- Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
- Willing to use acceptable methods of contraception
- Parent or guardian willing to provide informed consent, if applicable
Who cannot join
- History of liver disease
- History of substance abuse
- Previous treatment with lamotrigine or divalproex
- Lamotrigine or divalproex intolerance
About this study
Official title: Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination
This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.
Read the detailed description
Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.
Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.
- Conditions
- Bipolar Disorder, Depression
- Being tested
- Lamotrigine, Divalproex (DIV) ER, Placebo
- Keywords
- Lamotrigine, Divalproex, Antidepressant
- Medical subject headings
- Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LamotrigineDrug
Also called Lamictal, (LAM)
If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects.
Divalproex (DIV) ERDrug
Also called Depakote ER, valproic Acid
If the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg.
PlaceboDrug
Also called PBO
During the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion.
| Study group | Role | What they receive |
|---|---|---|
| lamotrigine plus divalproex ER | Active comparator | Participants will take active lamotrigine and active divalproex ER Receives: Drug: Lamotrigine; Drug: Divalproex (DIV) ER |
| lamotrigine plus placebo divalproex ER | Placebo comparator | Participants will take active lamotrigine and placebo Receives: Drug: Lamotrigine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mania Rating Scale
Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionFeb 2009
- Study completionApr 2009
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 The University of Texas Health Science Center at San AntonioThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Charles L. Bowden, The University of Texas Health Science Center at San Antonio
- Investigators
- Charles L. Bowden, MD, Principal investigator, 210-567-5405
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00183469
- Sponsor's protocol ID
- P20MH068662
- Other IDs
- 5P20MH068662, DSIR 83-ATSO
- Status last verified
- Apr 2017
- First submitted
- 13 Sep 2005
- Last updated
- 17 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bowden CL, Singh V, Weisler R, Thompson P, Chang X, Quinones M, Mintz J. Lamotrigine vs. lamotrigine plus divalproex in randomized, placebo-controlled maintenance treatment for bipolar depression. Acta Psychiatr Scand. 2012 Nov;126(5):342-50. doi: 10.1111/j.1600-0447.2012.01890.x. Epub 2012 Jun 18.
PubMed 22708645
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eight-Month Maintenance Treatment of Bipolar Depression With Lamotrigine or Lamotrigine Plus Divalproex Combination
- ClinicalTrials.gov ID
- NCT00183469
- Acronym / sponsor ID
- P20MH068662
- Conditions
- Bipolar Disorder, Depression
- Keywords
- Lamotrigine, Divalproex, Antidepressant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2004
- Primary completion
- Feb 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Posted 20 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare two different antidepressant treatment regimens to determine which is more effective in reducing symptoms of bipolar depression.
Detailed description
Depression is a serious condition that is often difficult to diagnosis and treat. Bipolar disorder-related depression is especially complex because of the presence of mania symptoms. Lamotrigine and divalproex are commonly prescribed medications for depression. However, their effectiveness in treating bipolar depression has not been thoroughly evaluated. Studies have shown that combining lamotrigine with another antidepressant may be more effective in reducing depressive symptoms than lamotrigine alone. This study will provide participants with either lamotrigine alone or in combination with divalproex and will determine which regimen is more effective in reducing symptoms of bipolar depression.
Participants will be randomly assigned to a daily regimen of either lamotrigine and divalproex or lamotrigine and placebo for 8 months. Participants will be assessed at study entry, at two unspecified times during the study, and at the end of the study. During each assessment, participants will undergo a brief interview and complete a questionnaire about their depressive symptoms, any physical manifestations of their depression, and their overall level of functioning in daily activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lamotrigine plus divalproex ER | Active comparator | Drug: Lamotrigine, Drug: Divalproex (DIV) ERParticipants will take active lamotrigine and active divalproex ER |
| lamotrigine plus placebo divalproex ER | Placebo comparator | Drug: Lamotrigine, Drug: PlaceboParticipants will take active lamotrigine and placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of bipolar disorder I or II
- Experiencing symptoms of depression at study entry OR have experienced symptoms of depression within 6 months prior to study entry
- Willing to use acceptable methods of contraception
- Parent or guardian willing to provide informed consent, if applicable
Key exclusion criteria (4 listed)
- History of liver disease
- History of substance abuse
- Previous treatment with lamotrigine or divalproex
- Lamotrigine or divalproex intolerance
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 |
|---|---|---|
| LamotrigineAlso: Lamictal, (LAM)If the participant is naive to LAM, LAM will be started at 25 mg every day for the first 2 weeks, then 50 mg per day for the next 2 weeks. The dose of LAM can be increased to 100 mg at week 5 and increased to maximum of 200 mg at week 6 based on symptoms, tolerability, and ratings of the rating scales. If the participant is already taking LAM, the dose will be increased to up to 200 mg using the same guide lines. Upon randomization the participant in the placebo comparator will have their dosage titrated to doubled since the potentiating effect of the Divalproex will no longer exist. It will remain at this dosage until the end of the study with the possibility of one adjustment for side effects. | Drug | lamotrigine plus divalproex ER, lamotrigine plus placebo divalproex ER |
| Divalproex (DIV) ERAlso: Depakote ER, valproic AcidIf the participant is naive to DIV and if LAM was initiated before the start of treatment with DIV, DIV can be started at any point of time in the study provided the participant has been on LAM for at least 2 weeks. DIV will be started at 500 mg and titrated by increments of 500 mg every 3 to 4 days until a therapeutic blood level is attained up to 2500 mg. | Drug | lamotrigine plus divalproex ER |
| PlaceboAlso: PBODuring the randomized phase participants randomized to placebo comparator group will discontinue DIV and will start taking the placebo in the same fashion. | Drug | lamotrigine plus placebo divalproex ER |
Primary outcome
Mania Rating Scale
Time frame: up to 8 months
Severity of the illness and psychopathological features will be measured by the increase in the SADS Mania Rating Scale, with higher scores representing worse mania. The range of this scale is 0-75.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22708645Bowden CL, Singh V, Weisler R, Thompson P, Chang X, Quinones M, Mintz J. Lamotrigine vs. lamotrigine plus divalproex in randomized, placebo-controlled maintenance treatment for bipolar depression. Acta Psychiatr Scand. 2012 Nov;126(5):342-50. doi: 10.1111/j.1600-0447.2012.01890.x. Epub 2012 Jun 18.
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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.
Charles L. Bowden, MD principal investigator
210-567-5405
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lamotrigine and Divalproex (DIV) ER in people with Bipolar Disorder and Depression, run by The University of Texas Health Science Center at San Antonio.
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 4 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 May 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. 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 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?
Yes. Results are posted in the registry (first posted 20 Apr 2015). 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?
Mania Rating Scale (time frame: up to 8 months). 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 NCT00183469, 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 May 2017.