Bipolar DisorderPhase 3NCT00074776
Acute Treatment of Bipolar II Depression
A Phase 3 study testing Lithium and Lamotrigine in people with Bipolar Disorder, run by Stanford University at 1 site in United States.
Trial summary
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- Lithium and Lamotrigine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Oct 2007
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Current diagnosis of bipolar II disorder
Who cannot join
- Use of lithium or lamotrigine
- Intolerance to lithium or lamotrigine
- Substance abuse or dependence within the last month
- Suicidal thoughts
- Unstable medical conditions
- Pregnancy or breast-feeding
Show all 10Show fewer
- Stable on current medications
- Use of fluoxetine (Prozac) within 2 weeks of study
- Require an antipsychotic medication
- Do not speak or read English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390-9121
About this study
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.
Read the detailed description
Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.
Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.
- Conditions
- Bipolar Disorder
- Being tested
- Lithium, Lamotrigine
- Keywords
- Bipolar Depression
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LithiumDrug
Participants will receive lithium.
LamotrigineDrug
Participants will receive lamotrigine.
| Study group | Role | What they receive |
|---|---|---|
| 1 Lithium | Experimental | Not described Receives: Drug: Lithium |
| 2 Lamotrigine | Experimental | Not described Receives: Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
Measured: Measured at baseline and Week 16
Secondary outcomes (3)
Incidence and severity of hypomanic and depressive symptoms
Measured: Measured at baseline and Week 16
Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)
Measured: Measured at baseline and Week 16
Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater
Measured: Measured at baseline and Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2003 (estimated)
- Study startMay 2003
- Primary completionOct 2007
- Study completionOct 2007
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.
- More trials run by Stanford UniversityThe 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
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Trisha Suppes, MD, PhD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00074776
- Sponsor's protocol ID
- R21MH067055
- Other IDs
- R21MH067055, DSIR 83-ATSO
- Status last verified
- Jul 2012
- First submitted
- 19 Dec 2003
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Suppes T, Marangell LB, Bernstein IH, Kelly DI, Fischer EG, Zboyan HA, Snow DE, Martinez M, Al Jurdi R, Shivakumar G, Sureddi S, Gonzalez R. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. J Affect Disord. 2008 Dec;111(2-3):334-43. doi: 10.1016/j.jad.2008.02.004. Epub 2008 Mar 20.
PubMed 18358540
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Treatment of Bipolar II Depression
- ClinicalTrials.gov ID
- NCT00074776
- Acronym / sponsor ID
- R21MH067055
- Conditions
- Bipolar Disorder
- Keywords
- Bipolar Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Dec 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.
This study will compare the medications lithium and lamotrigine (Lamictal®) in treating depression in individuals with bipolar II disorder.
Detailed description
Bipolar II disorder (BDII) is a serious condition characterized by depressive and hypomanic episodes. The disability and suicide risk associated with BDII is equal to bipolar I disorder. However, there are no clinical trials for BDII, nor is the treatment of BDII addressed in current treatment guidelines. Data suggest that Li and LTG may be effective treatment options for BDII. This study will determine the safety, effectiveness, and tolerability of the two drugs in people with BDII.
Participants in this study will be randomly assigned to receive either Li or LTG for 16 weeks. Participants will be assessed every 2 weeks. One week after study completion, participants will have a follow-up visit. Measures of depression, mania, quality of life, functioning, and participant satisfaction will be taken.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Lithium | Experimental | Drug: Lithium |
| 2 Lamotrigine | Experimental | Drug: Lamotrigine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Current diagnosis of bipolar II disorder
Key exclusion criteria (10 listed)
- Use of lithium or lamotrigine
- Intolerance to lithium or lamotrigine
- Substance abuse or dependence within the last month
- Suicidal thoughts
- Unstable medical conditions
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 |
|---|---|---|
| LithiumParticipants will receive lithium. | Drug | 1 Lithium |
| LamotrigineParticipants will receive lamotrigine. | Drug | 2 Lamotrigine |
Primary outcome
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
Time frame: Measured at baseline and Week 16
3 secondary outcomes
Incidence and severity of hypomanic and depressive symptoms
Time frame: Measured at baseline and Week 16
Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)
Time frame: Measured at baseline and Week 16
Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater
Time frame: Measured at baseline and Week 16
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 23 Jul 2012.
- Results publication: PubMed 18358540Suppes T, Marangell LB, Bernstein IH, Kelly DI, Fischer EG, Zboyan HA, Snow DE, Martinez M, Al Jurdi R, Shivakumar G, Sureddi S, Gonzalez R. A single blind comparison of lithium and lamotrigine for the treatment of bipolar II depression. J Affect Disord. 2008 Dec;111(2-3):334-43. doi: 10.1016/j.jad.2008.02.004. Epub 2008 Mar 20.
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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.
Trisha Suppes, MD, PhD principal investigator
Stanford University
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 Lithium and Lamotrigine in people with Bipolar Disorder, run by Stanford University 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 1 inclusion and 10 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 23 Jul 2012. 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. 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 in depression symptoms, as measured by the Hamilton Rating Scale for Depression (time frame: Measured at baseline and Week 16). 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 NCT00074776, 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 23 Jul 2012.