Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 215 for:    Lamotrigine

Lamotrigine for Symptoms of Geriatric Bipolar Depression (Geri-BD SAD)

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: NCT00621842
Recruitment Status : Completed
First Posted : February 22, 2008
Results First Posted : October 25, 2011
Last Update Posted : December 30, 2014
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals Cleveland Medical Center

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Bipolar Disorder
Depression, Bipolar
Interventions Drug: Lamotrigine regular tablet formulation
Drug: Lamotrigine novel formulation
Enrollment 57
Recruitment Details Recruitment began in January 2008 and ended in December 2009. The study screened and enrolled participants at five academic institutions in the United States.
Pre-assignment Details All subjects were required to have a score of 18 or higher on the Hamilton Rating Scale for Depression 24 to be included in the study.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description This solitary group received open-label lamotrigine treatment for bipolar depression.
Period Title: Overall Study
Started 57
Completed 38
Not Completed 19
Reason Not Completed
Adverse Event             6
Withdrawal by Subject             7
Protocol Violation             4
Lack of Efficacy             2
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Baseline Participants 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  47.4%
>=65 years
30
  52.6%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 57 participants
66.5  (6.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants
Female
23
  40.4%
Male
34
  59.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants
57
1.Primary Outcome
Title Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
Hide Description The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-15.5
(-18.0 to -12.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method t-test, 2 sided
Comments df=53
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.5
Confidence Interval (2-Sided) 95%
-18.0 to -12.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)
Hide Description Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was chosen from the number who received at least one dose of lamotrigine.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
reduced sleep duration 14
weight loss 12
increased dream activity 12
polyuria/polydipsia 11
weight gain 9
increased sleep 9
lassitude/fatigue 8
unsteady gait 8
3.Secondary Outcome
Title Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)
Hide Description The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 54
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-15.2
(-17.5 to -12.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -15.2
Confidence Interval (2-Sided) 95%
-17.5 to -12.9
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)
Hide Description The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 49
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-.47
(-1.82 to .88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference score between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .49
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.47
Confidence Interval (2-Sided) 95%
-1.82 to .88
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP
Hide Description The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 53
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2.06
(-2.43 to -1.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.06
Confidence Interval (2-Sided) 95%
-2.43 to -1.68
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)
Hide Description The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 48
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-.04
(-.36 to .28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .80
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.04
Confidence Interval (2-Sided) 95%
-.36 to .28
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change in Body Weight From Baseline
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 52
Mean (95% Confidence Interval)
Unit of Measure: lbs.
.83
(-.97 to 2.62)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .36
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .83
Confidence Interval 95%
-.97 to 2.62
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Participants Who Fell at Least Once During the Study
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was chosen from the number who received at least one dose of lamotrigine.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
18
9.Secondary Outcome
Title Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)
Hide Description The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 48
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-.79
(-1.67 to .09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .08
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.79
Confidence Interval (2-Sided) 95%
-1.67 to .09
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)
Hide Description The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants for analysis was determined by number of completers plus number of dropouts where the last known observation of a dropout taking lamotrigine was carried forward. Missing data and the lack of 3 participants completing more than the baseline assessment yielded a number for analysis that was less than total enrollment.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 47
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-.53
(-1.03 to -.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Open-label Lamotrigine Treatment
Comments The null hypothesis is that the mean difference between the 12 week time point or LOCF and baseline is zero.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .04
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -.53
Confidence Interval 95%
-1.03 to -.04
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Number of Participants Who Had a Fall That Required Medical Attention
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was chosen from the number who received at least one dose of lamotrigine.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
5
12.Secondary Outcome
Title Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants was chosen from the number who received at least one dose of lamotrigine.
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description:
This solitary group received open-label lamotrigine treatment for bipolar depression.
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
1
Time Frame Adverse event data was collected for the duration of the study (over two years) separate from any data collected using the UKU.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Open-label Lamotrigine Treatment
Hide Arm/Group Description This solitary group received open-label lamotrigine treatment for bipolar depression.
All-Cause Mortality
Open-label Lamotrigine Treatment
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Open-label Lamotrigine Treatment
Affected / at Risk (%) # Events
Total   2/57 (3.51%)    
Psychiatric disorders   
Hospital Admission for Increased Anxiety *  1/57 (1.75%)  1
Renal and urinary disorders   
Hospital Admission for Urinary Tract Infection *  1/57 (1.75%)  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%
Open-label Lamotrigine Treatment
Affected / at Risk (%) # Events
Total   22/57 (38.60%)    
Gastrointestinal disorders   
Vomiting *  4/57 (7.02%)  9
Injury, poisoning and procedural complications   
Fall *  18/57 (31.58%)  28
Metabolism and nutrition disorders   
Weight gain *  4/57 (7.02%)  4
Weight Loss *  4/57 (7.02%)  6
Renal and urinary disorders   
Increased Urinary Frequency *  3/57 (5.26%)  4
Skin and subcutaneous tissue disorders   
Rash *  4/57 (7.02%)  4
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Christopher Bialko
Organization: Case Western Reserve University
Phone: 216-286-4362
EMail: Christopher.Bialko@UHhospitals.org
Layout table for additonal information
Responsible Party: Martha Sajatovic, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00621842     History of Changes
Other Study ID Numbers: L0971
GSK110720
IND 78,081 ( Other Identifier: FDA )
First Submitted: February 12, 2008
First Posted: February 22, 2008
Results First Submitted: August 9, 2011
Results First Posted: October 25, 2011
Last Update Posted: December 30, 2014