Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if patients with melancholic bipolar II depression are more responsive to lamotrigine than patients with non-melancholic bipolar II depression. To do this, the investigators will re-analyze a previous clinical trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Saskatchewan
• Collaborator: GlaxoSmithKline
• Treatments: Anticonvulsants; Lamotrigine

Criteria

Inclusion Criteria:

1. Patients must provide written and informed consent.

2. Diagnosis of Bipolar II Disorder and currently depressed for minimum of the last 8 weeks, with a HAMD-17 score of at least 18 with scores of 3 or more on Items 1 or 7.

3. For females, be of non-childbearing potential, or of childbearing potential with a negative pregnancy test at screening and agrees to one of (a) abstinence from sex two weeks prior and five days after drug continuation/discontinuation, (b) personal or partner sterilization, (c) one method of hormonal contraception, or (d) two barrier methods of contraception.

4. Acceptable results (within two times the normal limit) on laboratory screening tests (e.g., thyroid function).

Exclusion Criteria:

1. Active suicidality.

2. History of non-response to antidepressant treatment, or any previous treatment with lamotrigine.

3. History of substance dependence in the past year, or abuse within the 4 weeks prior to study entry.

4. Rapid cycling bipolar disorder.

5. Receiving additional psychoactive medication (not including lorazepam for agitation), or has started a new course of psychotherapy within the last month.

6. Received treatment for an anxiety or eating disorder within the last 12 months.

7. Investigational drug use within the last month.

8. History of epilepsy.