Bipolar Depression, Bipolar Disorder, Depression, Lamotrigine, Melancholia
Conditions
Brief 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).
Detailed description
Patients suffering from depression with melancholic symptoms (i.e., anhedonia, flat affect, diurnal mood variation, terminal insomnia, psychomotor disturbances, decreased weight/appetite, and excessive guilt) respond better to certain antidepressants. Melancholic symptoms also occur in bipolar depression, although they have received less research. Lamotrigine has been shown to alter some of the biological processes that are known to occur in melancholic depression. 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. This study will re-analyze data from a previous 8-week, randomized, placebo-controlled trial that evaluated lamotrigine as a treatment for bipolar II depression (GSK-SCA100223; NCT00274677). The original study data was made available by GlaxoSmithKline as part of an initiative to make clinical trials data available for research use. Access was applied for via https://www.clinicalstudydatarequest.com. The analysis strategy will be comparable to the original study, although the investigators will first classify participants as suffering from either melancholic or non-melancholic depression. The diagnosis of melancholic depression was established according to baseline responses to the Hamilton Depression Rating Scale (HAMD-17) and the Montgomery-Åsberg Depression Rating Scale (MADRS), according to the DSM-IV-TR diagnostic criteria. HAMD-17 and MADRS change scores will be compared between the treatment and placebo groups using Analysis of Variance (ANOVA). Both ANOVA models will include a test for an interaction between treatment group (lamotrigine vs. placebo) and melancholic depression (melancholic depression vs. non-melancholic depression). To handle missing data, each ANOVA model will be computed with only complete-case data first and subsequently using inverse probability weights that account for the probability of drop out. Inverse probability weights will be created based on covariates that predict missing responses. HAMD-17 and MADRS response rates between the treatment and placebo groups will be evaluated with a Cox proportional hazard regression analysis. There will be two separate analyses, one including participants with melancholic depression, and one including participants with non-melancholic depression. Statistical models will also adjust for baseline depression severity, if participants with melancholic depression are found to have more severe depressive symptoms at baseline. Given the delay between antidepressant initiation and response, trial-and-error prescribing is an inevitably lengthy process. The investigators hope the results of this study will enable more timely and effective treatment for patients with bipolar depression.
Interventions
DRUGLamotrigine
Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.
DRUGPlacebos
Placebo tablets
Sponsors
GlaxoSmithKline
University of Saskatchewan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores | Eight weeks | Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms. |
| Hamilton Depression Rating Scale (HAMD-17) Change Scores | Eight weeks | Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms. |
| Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | Eight weeks | Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%. |
| Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | Eight weeks | Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%. |
Countries
Canada
Participant flow
Recruitment details
This study only analyzed data from treatment completers in the original study, NCT00274677. The original study enrolled 221 participants, with 150 completing the trial.
Participants by arm
| Arm | Count |
|---|---|
| Lamotrigine - Melancholic Depression Participants with melancholic depression who were randomly assigned to receive lamotrigine tablets escalated to a target dose of 200mg/day.
Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8. | 46 |
| Placebo - Melancholic Depression Participants with melancholic depression who were randomly assigned to receive a placebo comparator.
Placebos: Placebo tablets | 44 |
| Lamotrigine - Nonmelancholic Depression 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.
Lamotrigine: Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8. | 30 |
| Placebo - Nonmelancholic Depression Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.
Placebos: Placebo tablets | 30 |
| Total | 150 |
Baseline characteristics
| Characteristic | Lamotrigine - Melancholic Depression | Placebo - Melancholic Depression | Lamotrigine - Nonmelancholic Depression | Placebo - Nonmelancholic Depression | Total |
|---|---|---|---|---|---|
| Age, Continuous | 38.2 years STANDARD_DEVIATION 12.5 | 37.8 years STANDARD_DEVIATION 10.9 | 41.2 years STANDARD_DEVIATION 10.6 | 35.8 years STANDARD_DEVIATION 11.2 | 38.2 years STANDARD_DEVIATION 11.4 |
| Sex: Female, Male Female | 31 Participants | 32 Participants | 19 Participants | 17 Participants | 99 Participants |
| Sex: Female, Male Male | 15 Participants | 12 Participants | 11 Participants | 13 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 109 | 0 / 109 |
| other Total, other adverse events | 88 / 109 | 85 / 109 |
| serious Total, serious adverse events | 0 / 109 | 5 / 109 |
Outcome results
Primary
Hamilton Depression Rating Scale (HAMD-17) Change Scores
Scale scores range from 0 to 52. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms.
Time frame: Eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lamotrigine - Melancholic Depression | Hamilton Depression Rating Scale (HAMD-17) Change Scores | -13.5 score on a scale | Standard Deviation 7.92 |
| Placebo - Melancholic Depression | Hamilton Depression Rating Scale (HAMD-17) Change Scores | -10.9 score on a scale | Standard Deviation 9.52 |
| Lamotrigine - Nonmelancholic Depression | Hamilton Depression Rating Scale (HAMD-17) Change Scores | -13.0 score on a scale | Standard Deviation 7.59 |
| Placebo - Nonmelancholic Depression | Hamilton Depression Rating Scale (HAMD-17) Change Scores | -10.6 score on a scale | Standard Deviation 6.55 |
Comparison: Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.p-value: 0.84ANOVA
Primary
Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores
Scale scores range from 0 to 60. This outcome is a change score calculated by subtracting Baseline from Week 8 scores. Lower scores indicate greater improvement of depressive symptoms.
Time frame: Eight weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lamotrigine - Melancholic Depression | Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores | -15.7 score on a scale | Standard Deviation 10.8 |
| Placebo - Melancholic Depression | Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores | -13.8 score on a scale | Standard Deviation 11.6 |
| Lamotrigine - Nonmelancholic Depression | Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores | -16.0 score on a scale | Standard Deviation 10.5 |
| Placebo - Nonmelancholic Depression | Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores | -15.5 score on a scale | Standard Deviation 9.93 |
Comparison: Weighted ANOVA models were used to compare change scores between lamotrigine and placebo groups while testing for interactions by melancholic status. The estimate and test reported is for the the interaction between treatment condition and melancholic status.p-value: 0.59ANOVA
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Five weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 22 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 19 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 10 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 9 Participants |
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Eight weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 25 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 22 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 20 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 14 Participants |
Comparison: Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response.p-value: 0.02Regression, Cox
Comparison: Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at any time point and 0 indicating no response.p-value: 0.73Regression, Cox
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Seven weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 28 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 19 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 15 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 18 Participants |
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Six weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 29 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 17 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 14 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 11 Participants |
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Four weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 16 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 13 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 9 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 11 Participants |
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Three weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 11 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 9 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 8 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 7 Participants |
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Two weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 7 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 6 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 5 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 4 Participants |
Primary
Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Scale scores range from 0 to 52. A response is defined as a score reduction from baseline of at least 50%.
Time frame: One week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 3 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 2 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 1 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17) | 1 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: One week
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 5 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 3 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 2 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 2 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Eight weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 28 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 22 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 20 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 16 Participants |
Comparison: Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response.p-value: 0.08Regression, Cox
Comparison: Weighted Cox regression with treatment condition (lamotrigine vs. placebo) predicting treatment response. Response is defined as a score reduction of at least 50% from baseline. The outcome variable is binary coded with 1 being a response at anytime point and 0 indicating no response.p-value: 0.53Regression, Cox
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Seven weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 27 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 21 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 20 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 20 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Six weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 28 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 19 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 15 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 13 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Five weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 25 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 19 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 12 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 9 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Four weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 14 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 16 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 9 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 8 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Three weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 11 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 10 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 8 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 8 Participants |
Primary
Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Scale scores range from 0 to 60. A response is defined as a score reduction from baseline of at least 50%.
Time frame: Two weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lamotrigine - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 6 Participants |
| Placebo - Melancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 6 Participants |
| Lamotrigine - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 3 Participants |
| Placebo - Nonmelancholic Depression | Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS) | 4 Participants |