Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
Depression, Bipolar Disorder, Bipolar Depression
About this trial
This is an interventional treatment trial for Depression
Eligibility Criteria
Inclusion Criteria:
- Patients must provide written and informed consent.
- 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.
- 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.
- Acceptable results (within two times the normal limit) on laboratory screening tests (e.g., thyroid function).
Exclusion Criteria:
- Active suicidality.
- History of non-response to antidepressant treatment, or any previous treatment with lamotrigine.
- History of substance dependence in the past year, or abuse within the 4 weeks prior to study entry.
- Rapid cycling bipolar disorder.
- Receiving additional psychoactive medication (not including lorazepam for agitation), or has started a new course of psychotherapy within the last month.
- Received treatment for an anxiety or eating disorder within the last 12 months.
- Investigational drug use within the last month.
- History of epilepsy.
Sites / Locations
- Department of Psychiatry, Royal University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Lamotrigine - melancholic depression
Placebo - melancholic depression
Lamotrigine - nonmelancholic depression
Placebo - nonmelancholic depression
Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.
Participants with melancholic depression who were randomly assigned to receive a placebo comparator.
Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.
Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.