Acute Treatment of Bipolar II Depression

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00074776

Enrollment

102

Registered

2003-12-22

Start date

2003-05-31

Completion date

2007-10-31

Last updated

2012-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bipolar Disorder

Keywords

Bipolar Depression

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.

Interventions

DRUGLithium

Participants will receive lithium.

DRUGLamotrigine

Participants will receive lamotrigine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in depression symptoms, as measured by the Hamilton Rating Scale for Depression	Measured at baseline and Week 16

Secondary

Measure	Time frame
Incidence and severity of hypomanic and depressive symptoms	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 at baseline and Week 16
Switch into hypomania, defined as a CGI-BP Mania severity score of 4 or greater	Measured at baseline and Week 16

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026