Bipolar DisorderNCT00451542
Divalproex vs. Lamotrigine for Bipolar Disorder
An observational study of Bipolar Disorder, run by Tuscaloosa Research & Education Advancement Corporation.
Trial summary
This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bipolar Disorder
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2006to 1 Feb 2008
- Phase
- Observational
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Bipolar Disorder I or II who had a prescription of divalproex or lamotrigine.
Who may be able to join
- Diagnosis of Bipolar I or Bipolar II disorder
- Prescription of divalproex (any formulation except for Depakene/valproic acid) or lamotrigine in the electronic pharmacy profile.
- Age 19 or older
- Demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalproex).
- Treatment at the TVAMC for at least 6 months following the prescription of divalproex or lamotrigine.
Who cannot join
- Primary diagnosis of schizoaffective or schizophrenia during the evaluation period.
- Prescription of divalproex and lamotrigine given concurrently during the observation period.
- History of Dementia or cognitive disorders
About this study
Official title: Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder
This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.
Read the detailed description
The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Relapse, Retrospective
- Medical subject headings
- Bipolar Disorder, Recurrence
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2007 (estimated)
- Study start1 Feb 2006
- Primary completion1 May 2007
- Study completion1 Feb 2008
Why it stopped: Sample too small in retrospective chart review to conduct analysis
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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuscaloosa Research & Education Advancement Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lori Davis, MD, Tuscaloosa Research & Education Advancement Corporation
- Investigators
- Lori L Davis, MD, Principal investigator, Tuscaloosa Reseach and Education Advancement Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00451542
- Sponsor's protocol ID
- 0063
- Status last verified
- Apr 2017
- First submitted
- 21 Mar 2007
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vieta E, Rosa AR. Evolving trends in the long-term treatment of bipolar disorder. World J Biol Psychiatry. 2007;8(1):4-11. doi: 10.1080/15622970601083280.
PubMed 17366344
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Relapse During Treatment With Divalproex vs. Lamotrigine for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT00451542
- Acronym / sponsor ID
- 0063
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Disorder, Relapse, Retrospective
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sample too small in retrospective chart review to conduct analysis
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Tuscaloosa Research & Education Advancement CorporationUniversity, hospital or other
- Study start
- 1 Feb 2006 (actual)
- Primary completion
- 1 May 2007 (actual)
- Study completion
- 1 Feb 2008 (actual)
- First posted
- 23 Mar 2007 (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.
This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.
Detailed description
The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Bipolar Disorder I or II who had a prescription of divalproex or lamotrigine.
Key inclusion criteria (5 listed)
- Diagnosis of Bipolar I or Bipolar II disorder
- Prescription of divalproex (any formulation except for Depakene/valproic acid) or lamotrigine in the electronic pharmacy profile.
- Age 19 or older
- Demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalproex).
- Treatment at the TVAMC for at least 6 months following the prescription of divalproex or lamotrigine.
Key exclusion criteria (3 listed)
- Primary diagnosis of schizoaffective or schizophrenia during the evaluation period.
- Prescription of divalproex and lamotrigine given concurrently during the observation period.
- History of Dementia or cognitive disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: Sample too small in retrospective chart review to conduct analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Background: PubMed 17366344Vieta E, Rosa AR. Evolving trends in the long-term treatment of bipolar disorder. World J Biol Psychiatry. 2007;8(1):4-11. doi: 10.1080/15622970601083280.
- Individual participant dataSharing planned: No
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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.
Lori L Davis, MD principal investigator
Tuscaloosa Reseach and Education Advancement Corporation
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder, run by Tuscaloosa Research & Education Advancement Corporation.
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 5 inclusion and 3 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 27 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.
Are results available for this study?
The study was stopped early (reason given: Sample too small in retrospective chart review to conduct analysis). 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00451542, 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 27 Apr 2017.