Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 40 of 215 for:    Lamotrigine

Lamotrigine Therapy in Geriatric Bipolar Depression

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: NCT00720473
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : July 21, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition Bipolar Depression
Intervention Drug: Lamotrigine
Enrollment 69
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A: BPD Subjects B: Healthy Control
Hide Arm/Group Description

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

No Intervention
Period Title: Overall Study
Started 45 24
Completed 15 16
Not Completed 30 8
Arm/Group Title BPD Subjects Control Subjects Total
Hide Arm/Group Description

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD Total of all reporting groups
Overall Number of Baseline Participants 23 14 37
Hide Baseline Analysis Population Description
Baseline scans were available for 37 participants, 23 BPD subjects and 14 for healthy controls. One participant had missing scan data, and twenty one participants with a BPD diagnosis had baseline MADRS scores available.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 14 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
17
  73.9%
7
  50.0%
24
  64.9%
>=65 years
6
  26.1%
7
  50.0%
13
  35.1%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 23 participants 14 participants 37 participants
62.0  (5.9) 67.5  (8.8) 64.6  (7.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 23 participants 14 participants 37 participants
Female
9
  39.1%
7
  50.0%
16
  43.2%
Male
14
  60.9%
7
  50.0%
21
  56.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 23 participants 14 participants 37 participants
23 14 37
1.Primary Outcome
Title Mean Glutamine to Creatine Ratio by Diagnosis at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline scans were available for 37 participants. One participant was missing scan data.
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 22 14
Mean (Standard Deviation)
Unit of Measure: mean serum Glutamine to Creatine ratio
.34  (.12) .36  (.18)
2.Primary Outcome
Title Mean Glutamate to Creatine Ratio by Diagnosis at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline scans were available for 37 participants. One participant was missing scan data.
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 22 14
Mean (Standard Deviation)
Unit of Measure: mean serum Glutamate to Creatine ratio
.96  (.29) .85  (.25)
3.Primary Outcome
Title Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline
Hide Description [Not Specified]
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Baseline scans were available for 37 participants. One participant was missing scan data.
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 22 14
Mean (Standard Deviation)
Unit of Measure: Mean NAA to creatine ratio
0.97  (0.14) 0.84  (0.22)
4.Primary Outcome
Title Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline
Hide Description Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.
Arm/Group Title A: Other
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Overall Number of Participants Analyzed 21
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Glu:Cr/+10 MADRS
0.18
(-0.02 to 0.38)
5.Primary Outcome
Title Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up
Hide Description Follow-up Least Squares Mean - Baseline Least Squares Mean
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 13 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: serum Glutamate to Creatine ratio
0.00
(-0.17 to 0.16)
-0.12
(-0.30 to 0.07)
6.Primary Outcome
Title Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up
Hide Description Follow-up Least Squares Mean - Baseline Least Squares Mean
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 13 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: serum Glutamine to Creatine ratio
0.02
(-0.09 to 0.14)
0.08
(-0.05 to 0.21)
7.Primary Outcome
Title Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up
Hide Description Follow-up Least Squares Mean - Baseline Least Squares Mean
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 13 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: NAA to creatine ratio
0.06
(-0.06 to 0.19)
-0.03
(-0.16 to 0.10)
8.Primary Outcome
Title Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up
Hide Description Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.
Arm/Group Title BPD Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Overall Number of Participants Analyzed 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Glu:Cr/-10 MADRS
-.007
(-0.24 to 0.23)
9.Primary Outcome
Title Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up
Hide Description Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.
Arm/Group Title BPD Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Overall Number of Participants Analyzed 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Gln:Cr/-10 MADRS Score
0.04
(-0.07 to 0.14)
10.Primary Outcome
Title Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up
Hide Description Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Association between depression symptom severity and metabolite ratios were only conducted in the depressed group, because there should be no change in MADRS score for non-depressed control subjects who received no treatment.
Arm/Group Title BPD Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Overall Number of Participants Analyzed 11
Least Squares Mean (95% Confidence Interval)
Unit of Measure: NAA:Cr/-10 MADRS
0.05
(-0.04 to 0.15)
11.Primary Outcome
Title Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline
Hide Description The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
MADRS scores were available for 27 eligible bipolar subjects and 14 eligible controls.
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 27 14
Mean (Standard Deviation)
Unit of Measure: units on a scale
24.78  (6.65) 1.03  (1.55)
12.Primary Outcome
Title Means of MADRS Scores at 8 Weeks
Hide Description The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.
Time Frame 8 Weeks
Hide Outcome Measure Data
Hide Analysis Population Description
MADRS scores were available for 16 bipolar subjects who completed the protocol and 8 healthy controls.
Arm/Group Title BPD Subjects Control Subjects
Hide Arm/Group Description:

Open Label Study

Lamotrigine : Lamotrigine with dosage range from 25 mg to 200 mg per day.

Age matched controls without BPD
Overall Number of Participants Analyzed 16 8
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.31  (9.41) 1.38  (1.51)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Subjects BPD Subjects
Hide Arm/Group Description Age matched controls without BPD [Not Specified]
All-Cause Mortality
Control Subjects BPD Subjects
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control Subjects BPD Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      2/45 (4.44%)    
Injury, poisoning and procedural complications     
Loss of consciousness [1]  0/24 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders     
Mania [2]  0/24 (0.00%)  0 1/45 (2.22%)  1
[1]
Subject fell off bicycle and lost consciousness.
[2]
Subject was hospitalized due to mania
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Subjects BPD Subjects
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/24 (0.00%)      14/45 (31.11%)    
Eye disorders     
Blurry Vision [1]  0/24 (0.00%)  0 1/45 (2.22%)  1
Gastrointestinal disorders     
Stomach upset [2]  0/24 (0.00%)  0 2/45 (4.44%)  2
General disorders     
Decreased balance [3]  0/24 (0.00%)  0 3/45 (6.67%)  3
Headache [4]  0/24 (0.00%)  0 2/45 (4.44%)  2
Metabolism and nutrition disorders     
Weight gain [5]  0/24 (0.00%)  0 1/45 (2.22%)  1
Psychiatric disorders     
mania [6]  0/24 (0.00%)  0 1/45 (2.22%)  1
Insomnia [7]  0/24 (0.00%)  0 4/45 (8.89%)  4
Irritability [8]  0/24 (0.00%)  0 1/45 (2.22%)  1
Respiratory, thoracic and mediastinal disorders     
Runny Nose [9]  0/24 (0.00%)  0 1/45 (2.22%)  1
Skin and subcutaneous tissue disorders     
Rash [10]  0/24 (0.00%)  0 1/45 (2.22%)  1
Rash [11]  0/24 (0.00%)  0 1/45 (2.22%)  1
Blister [12]  0/24 (0.00%)  0 1/45 (2.22%)  1
[1]
Subject reported blurry vision
[2]
Two subject reported gastrointestinal problems including upset stomach and indigestion.
[3]
Three subjects reported feeling unbalanced or dizzy.
[4]
Two subjects reported mild headaches.
[5]
A subject reported gaining one pound.
[6]
Subject entered a manic state, with decreased sleep, pressured speech, and delusions.
[7]
Four subjects reported sleep disturbances.
[8]
One subject experienced increased irritability
[9]
One subject reported a mild runny nose.
[10]
Subject developed a rash, which was found to be unrelated by the subject's dermatologist.
[11]
Subject developed a rash after taking second dose.
[12]
Subject reported developing a blister on the hand.
Limited data was available for associating changes in MADRS scores with metabolite changes (22 regions from 11 participants with BPD).
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. Brent Forester
Organization: McLean Hospital
Phone: (617) 855-3622
EMail: bforester@partners.org
Layout table for additonal information
Responsible Party: Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00720473     History of Changes
Other Study ID Numbers: 2005-P-002493
First Submitted: July 18, 2008
First Posted: July 22, 2008
Results First Submitted: November 26, 2013
Results First Posted: July 21, 2016
Last Update Posted: February 1, 2017