Phase 4
N=150
Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine
Depression · Bipolar Disorder · Bipolar Depression · Melancholia · Lamotrigine
Bottom Line
View on ClinicalTrials.gov: NCT02989727 ↗Enrolled (actual)
150
Serious AEs
2.3%
Results posted
Feb 2019
Primary outcome: Primary: Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores — -15.7; -13.8; -16.0; -15.5 score on a scale — p=.59
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lamotrigine (Drug); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Saskatchewan
- Primary completion
- Aug 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores |
-15.7; -13.8; -16.0; -15.5 | .59 |
| PRIMARY Hamilton Depression Rating Scale (HAMD-17) Change Scores |
-13.5; -10.9; -13.0; -10.6 | .84 |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) |
5; 3; 2; 2 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
| PRIMARY Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) |
3; 2; 1; 1 | — |
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).
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.
Data sourced from ClinicalTrials.gov (NCT02989727). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.