Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 215 for:    Lamotrigine

Melancholic Symptoms in Bipolar Depression and Responsiveness to Lamotrigine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02989727
Recruitment Status : Completed
First Posted : December 12, 2016
Results First Posted : February 15, 2019
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Evyn Peters, University of Saskatchewan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Conditions Depression
Bipolar Disorder
Bipolar Depression
Melancholia
Lamotrigine
Interventions Drug: Lamotrigine
Drug: Placebos
Enrollment 150
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.
Pre-assignment Details  
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Period Title: Overall Study
Started [1] 46 44 30 30
Completed 46 44 30 30
Not Completed 0 0 0 0
[1]
We only analyzed data from treatment completers (n=150) in the original study (n=221), NCT00274677.
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression Total
Hide Arm/Group Description

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Total of all reporting groups
Overall Number of Baseline Participants 46 44 30 30 150
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 44 participants 30 participants 30 participants 150 participants
38.2  (12.5) 37.8  (10.9) 41.2  (10.6) 35.8  (11.2) 38.2  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 44 participants 30 participants 30 participants 150 participants
Female
31
  67.4%
32
  72.7%
19
  63.3%
17
  56.7%
99
  66.0%
Male
15
  32.6%
12
  27.3%
11
  36.7%
13
  43.3%
51
  34.0%
1.Primary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Change Scores
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-15.7  (10.8) -13.8  (11.6) -16.0  (10.5) -15.5  (9.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine - Melancholic Depression, Placebo - Melancholic Depression, Lamotrigine - Nonmelancholic Depression, Placebo - Nonmelancholic Depression
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .59
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ANOVA estimate
Estimated Value 1.88
Parameter Dispersion
Type: Standard Error of the Mean
Value: 3.51
Estimation Comments [Not Specified]
2.Primary Outcome
Title Hamilton Depression Rating Scale (HAMD-17) Change Scores
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Mean (Standard Deviation)
Unit of Measure: score on a scale
-13.5  (7.92) -10.9  (9.52) -13.0  (7.59) -10.6  (6.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine - Melancholic Depression, Placebo - Melancholic Depression, Lamotrigine - Nonmelancholic Depression, Placebo - Nonmelancholic Depression
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .84
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter ANOVA estimate
Estimated Value 0.5
Parameter Dispersion
Type: Standard Error of the Mean
Value: 2.56
Estimation Comments [Not Specified]
3.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
28
  60.9%
22
  50.0%
20
  66.7%
16
  53.3%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine - Melancholic Depression, Placebo - Melancholic Depression
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .08
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.2
Parameter Dispersion
Type: Standard Error of the Mean
Value: .10
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lamotrigine - Nonmelancholic Depression, Placebo - Nonmelancholic Depression
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .53
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.08
Parameter Dispersion
Type: Standard Error of the Mean
Value: .12
Estimation Comments [Not Specified]
4.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
27
  58.7%
21
  47.7%
20
  66.7%
20
  66.7%
5.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
28
  60.9%
19
  43.2%
15
  50.0%
13
  43.3%
6.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
25
  54.3%
19
  43.2%
12
  40.0%
9
  30.0%
7.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
14
  30.4%
16
  36.4%
9
  30.0%
8
  26.7%
8.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
11
  23.9%
10
  22.7%
8
  26.7%
8
  26.7%
9.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
6
  13.0%
6
  13.6%
3
  10.0%
4
  13.3%
10.Primary Outcome
Title Number of Participants With 50% Reduction in the Montgomery-Asberg Depression Rating Scale (MADRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
5
  10.9%
3
   6.8%
2
   6.7%
2
   6.7%
11.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
25
  54.3%
22
  50.0%
20
  66.7%
14
  46.7%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Lamotrigine - Melancholic Depression, Placebo - Melancholic Depression
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .02
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.27
Parameter Dispersion
Type: Standard Error of the Mean
Value: .11
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lamotrigine - Nonmelancholic Depression, Placebo - Nonmelancholic Depression
Comments 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.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .73
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 1.05
Parameter Dispersion
Type: Standard Error of the Mean
Value: .13
Estimation Comments [Not Specified]
12.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
28
  60.9%
19
  43.2%
15
  50.0%
18
  60.0%
13.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
29
  63.0%
17
  38.6%
14
  46.7%
11
  36.7%
14.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
22
  47.8%
19
  43.2%
10
  33.3%
9
  30.0%
15.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
16
  34.8%
13
  29.5%
9
  30.0%
11
  36.7%
16.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
11
  23.9%
9
  20.5%
8
  26.7%
7
  23.3%
17.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
7
  15.2%
6
  13.6%
5
  16.7%
4
  13.3%
18.Primary Outcome
Title Number of Participants With 50% Reduction in the Hamilton Depression Rating Scale (HAMD-17)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine - Melancholic Depression Placebo - Melancholic Depression Lamotrigine - Nonmelancholic Depression Placebo - Nonmelancholic Depression
Hide Arm/Group Description:

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.

Participants with melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

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.

Participants not meeting DSM-IV-TR diagnostic criteria for melancholic depression who were randomly assigned to receive a placebo comparator.

Placebos: Placebo tablets

Overall Number of Participants Analyzed 46 44 30 30
Measure Type: Count of Participants
Unit of Measure: Participants
3
   6.5%
2
   4.5%
1
   3.3%
1
   3.3%
Time Frame 8 weeks.
Adverse Event Reporting Description We have combined the two lamotrigine arms (melancholic and nonmelancholic) into one group, and also the two placebo arms (melancholic and nonmelancholic) into one group. We did not analyze safety data by melancholic status, so we are only able to report the original safety results (which was stratified by treatment condition but not melancholic status).
 
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description The data is from 109 participant that were randomized in the original trial. The data is from 109 participant that were randomized in the original trial.
All-Cause Mortality
Lamotrigine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/109 (0.00%)      0/109 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/109 (0.00%)      5/109 (4.59%)    
Psychiatric disorders     
Suicidal ideation *  0/109 (0.00%)  0 2/109 (1.83%)  2
Agitation *  0/109 (0.00%)  0 1/109 (0.92%)  1
Suicide attempt *  0/109 (0.00%)  0 1/109 (0.92%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumonia *  0/109 (0.00%)  0 1/109 (0.92%)  1
Skin and subcutaneous tissue disorders     
Cellulitis *  0/109 (0.00%)  0 1/109 (0.92%)  1
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Lamotrigine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   88/109 (80.73%)      85/109 (77.98%)    
Gastrointestinal disorders     
Nausea *  8/109 (7.34%)  15/109 (13.76%) 
Vomiting *  2/109 (1.83%)  6/109 (5.50%) 
General disorders     
Dry mouth *  10/109 (9.17%)  7/109 (6.42%) 
Nasopharyngitis *  0/109 (0.00%)  9/109 (8.26%) 
Dizziness *  7/109 (6.42%)  8/109 (7.34%) 
Sedation *  6/109 (5.50%)  2/109 (1.83%) 
Somnolence *  6/109 (5.50%)  5/109 (4.59%) 
Fatigue *  3/109 (2.75%)  7/109 (6.42%) 
Nervous system disorders     
Headache *  30/109 (27.52%)  39/109 (35.78%) 
Psychiatric disorders     
Insomnia *  9/109 (8.26%)  7/109 (6.42%) 
Respiratory, thoracic and mediastinal disorders     
Cough *  6/109 (5.50%)  5/109 (4.59%) 
Skin and subcutaneous tissue disorders     
Rash *  7/109 (6.42%)  7/109 (6.42%) 
*
Indicates events were collected by non-systematic assessment
  1. Short duration of trial in context of slow dosing regime
  2. Inability to assess other definitions of melancholia
  3. Sample of only bipolar II depression
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Evyn Peters
Organization: Univeristy of Saskatchewan
Phone: 13062904493
EMail: evyn.peters@usask.ca
Layout table for additonal information
Responsible Party: Evyn Peters, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02989727     History of Changes
Other Study ID Numbers: GSK-SCA100223
First Submitted: December 8, 2016
First Posted: December 12, 2016
Results First Submitted: December 27, 2017
Results First Posted: February 15, 2019
Last Update Posted: February 15, 2019