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Trial record 97 of 215 for:    Lamotrigine

Reversing Corticosteroid Induced Memory Impairment

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ClinicalTrials.gov Identifier: NCT01142310
Recruitment Status : Completed
First Posted : June 11, 2010
Results First Posted : August 27, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Memory Impairment
Interventions Drug: Lamotrigine
Drug: Placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description Participants took 25mg of Lamotrigine PO QD for two weeks. Dose was increased to 50mg PO QD at Week 2 for two weeks. Increased to 100mg PO QD at Week 4. Increased to 150mg PO QD at Week 5. Increased to 200mg PO QD at Week 6. Increased to 250mg PO QD at Week 7. Increased to 300mg PO QD at Week 8. Increased to 350mg PO QD at Week 9. Increased to 400mg PO QD at Week 10. Participants stayed at 400mg PO QD from Week 10 to Week 48. Placebo was administered the same as the Lamotrigine dose titration described.
Period Title: Overall Study
Started 26 28
Completed 17 16
Not Completed 9 12
Arm/Group Title Lamotrigine Placebo Total
Hide Arm/Group Description Participants took Lamotrigine beginning at 25mg/day and increased to a dose of 400mg/day over 10 weeks using a fixed scheduled. Placebo administered the same as the Lamotrigine. Total of all reporting groups
Overall Number of Baseline Participants 26 28 54
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 26 participants 28 participants 54 participants
42.192  (11.771) 46.286  (9.974) 44.315  (10.968)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Female
14
  53.8%
14
  50.0%
28
  51.9%
Male
12
  46.2%
14
  50.0%
26
  48.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Hispanic or Latino
7
  26.9%
9
  32.1%
16
  29.6%
Not Hispanic or Latino
19
  73.1%
18
  64.3%
37
  68.5%
Unknown or Not Reported
0
   0.0%
1
   3.6%
1
   1.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  50.0%
15
  53.6%
28
  51.9%
White
13
  50.0%
12
  42.9%
25
  46.3%
More than one race
0
   0.0%
1
   3.6%
1
   1.9%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Rey Auditory Verbal Learning Test (RAVLT)
Hide Description The Rey Auditory Verbal Learning Test (RAVLT) measures verbal or declarative learning and memory. The test consists of 15 nouns read aloud for five consecutive trials with each trial followed by a free-recall trial. Following the fifth trial, an interference list of 15 different words is presented followed by a free-recall trial of that list. Delayed recall of the first list is tested immediately following the interference list and after a 20-minute delay. A recognition test of 50 words including the 15 original words is presented after the delayed recall. Equivalent, alternative versions (different words) were used to minimize practice or learning effects from repeated administration. The raw scores (number of words correct across trials 1-5) are converted to standardized T-scores (M=50; SD=10). This score is used to determine the participant's performance in relation to norm-referenced expectations based on age and sex. A higher score reflects better performance.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description:
Participants took 25mg of Lamotrigine PO QD for two weeks. Dose was increased to 50mg PO QD at Week 2 for two weeks. Increased to 100mg PO QD at Week 4. Increased to 150mg PO QD at Week 5. Increased to 200mg PO QD at Week 6. Increased to 250mg PO QD at Week 7. Increased to 300mg PO QD at Week 8. Increased to 350mg PO QD at Week 9. Increased to 400mg PO QD at Week 10. Participants stayed at 400mg PO QD from Week 10 to Week 48.
Placebo was administered the same as the Lamotrigine dose titration described.
Overall Number of Participants Analyzed 26 28
Mean (Standard Deviation)
Unit of Measure: T Score
45.741  (9.63) 43.286  (6.57)
Time Frame Adverse events were collected during the study between baseline and end of study procedures, up to 48 weeks.
Adverse Event Reporting Description Adverse events were assessed by a weekly questionnaire at each appointment or when contacted by phone for a brief follow-up.
 
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description Participants took Lamotrigine beginning at 25mg PO QD and increased to a dose of 400mg PO QD over 10 weeks using a fixed scheduled. Placebo was administered the same as Lamotrigine.
All-Cause Mortality
Lamotrigine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)      1/28 (3.57%)    
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/26 (19.23%)      6/28 (21.43%)    
Blood and lymphatic system disorders     
Thrombosis  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Cardiac disorders     
Atrial Fibrillation  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Endocrine disorders     
Hyperglycemia  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Gastrointestinal disorders     
Gastroenteritis  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
General disorders     
Cancer  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Infections and infestations     
Kidney Stone  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Urinary Tract Infection  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Bacterial Vaginosis  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Pneumonia  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Influenza  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Reproductive system and breast disorders     
Vaginal Bleeding  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Surgical and medical procedures     
Foot Amputation  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Kidney Biopsy  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Vascular disorders     
Hypotension  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Indicates events were collected by systematic assessment
[1]
Serious, unexpected, not related to medication study
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamotrigine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/26 (7.69%)      3/28 (10.71%)    
Endocrine disorders     
Hypoglycemia  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Eye disorders     
Keratoconus  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
General disorders     
Dizziness  [1]  2/26 (7.69%)  2 0/28 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Nose Bleed  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Social circumstances     
Fall  [1]  1/26 (3.85%)  2 1/28 (3.57%)  1
Car Acciddent  [1]  0/26 (0.00%)  0 1/28 (3.57%)  1
Vascular disorders     
Hypotension  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Hypertension  [1]  1/26 (3.85%)  1 0/28 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Not serious, unexpected, not related to medication study
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. E. Sherwood Brown
Organization: UT Southwestern Medical Center
Phone: 214-645-6950
EMail: sherwood.brown@utsouthwestern.edu
Layout table for additonal information
Responsible Party: Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01142310     History of Changes
Other Study ID Numbers: 122009-028
R01MH082845 ( U.S. NIH Grant/Contract )
First Submitted: June 9, 2010
First Posted: June 11, 2010
Results First Submitted: June 1, 2018
Results First Posted: August 27, 2018
Last Update Posted: August 27, 2018