Clinical trial NCT00074776: Acute Treatment of Bipolar II Depression
Official title: Acute Treatment of Bipolar II Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2003-12-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* Current diagnosis of bipolar II disorder

Exclusion Criteria:

* 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
* Stable on current medications
* Use of fluoxetine (Prozac) within 2 weeks of study
* Require an antipsychotic medication
* Do not speak or read English

Primary outcomes:
measure: Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression
timeFrame: Measured at baseline and Week 16
Secondary outcomes:
measure: Incidence and severity of hypomanic and depressive symptoms
timeFrame: Measured at baseline and Week 16
measure: Medication tolerability, response (defined as a 50% reduction on the Ham-D), and remission (defined as Ham-D or MADRS score less than 12)
timeFrame: Measured at baseline and Week 16
measure: Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater
timeFrame: Measured at baseline and Week 16
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: Stanford University
name: Trisha Suppes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.