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Trial record 74 of 215 for:    Lamotrigine

Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency

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ClinicalTrials.gov Identifier: NCT00280293
Recruitment Status : Completed
First Posted : January 20, 2006
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
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: Treatment
Conditions Bipolar Disorder
Cocaine Dependence
Interventions Drug: Lamotrigine
Drug: Placebo
Enrollment 112
Recruitment Details 112 participants with at least one post-baseline visit were recruited between 2006 and 2010 at our research clinic in Dallas, TX and included for analysis.
Pre-assignment Details Participants with a diagnosis of bipolar I, II or NOS disorders currently depressed or mixed mood with current cocaine dependence and self-reported use within 14 days were included. The study drug was added to existing psychiatric medications or given as monotherapy when participants were not taking other medications at baseline.
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted. Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Period Title: Overall Study
Started 55 57
Completed 29 34
Not Completed 26 23
Reason Not Completed
Protocol Violation             3             0
Physician Decision             5             4
Lost to Follow-up             14             12
Withdrawal by Subject             3             5
Incarceration/Legal Reasons             1             1
Adverse Event             0             1
Arm/Group Title Lamotrigine Placebo Total
Hide Arm/Group Description Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted. Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted. Total of all reporting groups
Overall Number of Baseline Participants 55 57 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
55
 100.0%
57
 100.0%
112
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 55 participants 57 participants 112 participants
45.1  (7.3) 43.5  (10.0) 44.3  (8.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 55 participants 57 participants 112 participants
Female
23
  41.8%
22
  38.6%
45
  40.2%
Male
32
  58.2%
35
  61.4%
67
  59.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 55 participants 57 participants 112 participants
55 57 112
1.Primary Outcome
Title Days of Cocaine Use
Hide Description Number of days of cocaine use during the 7 days that comprise week 10 of the protocol, by self report, or at last assessment if participant withdrew early, as assessed by the Timeline Followback method.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description:
Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Overall Number of Participants Analyzed 55 57
Mean (Standard Deviation)
Unit of Measure: days
1.8  (2.0) 2.8  (4.0)
2.Primary Outcome
Title Positive Urine Drug Screens
Hide Description Percentage of participants with a positive urine drug screen for cocaine at the week 10 visit or at last assessment if participant withdrew early.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description:
Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Overall Number of Participants Analyzed 55 57
Measure Type: Number
Unit of Measure: percentage of participants
67.3 73.6
3.Secondary Outcome
Title Depression Score on the Hamilton Rating Scale For Depression
Hide Description Total score on the Hamilton Rating Scale for Depression at week 10 visit or at last assessment if participant withdrew early(total score values range 0 - 52. A higher score indicates more severe depression.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description:
Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Overall Number of Participants Analyzed 55 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
13.4  (8.5) 13.6  (8.2)
4.Secondary Outcome
Title Dollars Spent
Hide Description Dollars spent on cocaine during the 7 days of week 10, or at last assessment if participant withdrew early, based on self report.
Time Frame 10 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description:
Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
Overall Number of Participants Analyzed 55 57
Mean (Standard Deviation)
Unit of Measure: Dollars
68.6  (121.1) 155.4  (355.5)
Time Frame Adverse events were collected during the study between 2006 and 2010. Each participant was enrolled for 10 weeks. Adverse events were collected for the full 10 weeks, beginning after consent was signed.
Adverse Event Reporting Description Adverse events were assessed by a weekly questionnaire at each appointment.
 
Arm/Group Title Lamotrigine Placebo
Hide Arm/Group Description Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted. Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
All-Cause Mortality
Lamotrigine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/55 (9.09%)      4/57 (7.02%)    
Cardiac disorders     
Inpatient admittance due to hypertension   0/55 (0.00%)  0 1/57 (1.75%)  1
Congenital, familial and genetic disorders     
Inpatient admittance for blood transfusion  [1]  0/55 (0.00%)  0 1/57 (1.75%)  1
Infections and infestations     
Cellulitis   1/55 (1.82%)  1 0/57 (0.00%)  0
Injury, poisoning and procedural complications     
Fall related injury   2/55 (3.64%)  2 0/57 (0.00%)  0
Psychiatric disorders     
Inpatient psychiatric admittance  [2]  3/55 (5.45%)  3 1/57 (1.75%)  1
Expression of violent thoughts/ideation   1/55 (1.82%)  1 0/57 (0.00%)  0
Renal and urinary disorders     
Inpatient admittance for urinary tract blockage  [3]  0/55 (0.00%)  0 1/57 (1.75%)  1
Indicates events were collected by systematic assessment
[1]
Due to congenital Sickle Cell Anemia
[2]
For suicidal ideation/plan/intent
[3]
Due to pre-existing benign tumors
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   6/55 (10.91%)      4/57 (7.02%)    
Infections and infestations     
Abscessed Tooth   0/55 (0.00%)  0 1/57 (1.75%)  1
Injury, poisoning and procedural complications     
Cut related injury   1/55 (1.82%)  1 0/57 (0.00%)  0
Fall related injury   1/55 (1.82%)  1 0/57 (0.00%)  0
Psychiatric disorders     
Admittance to psychiatric facility  [1]  1/55 (1.82%)  1 0/57 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Hemoptysis   0/55 (0.00%)  0 1/57 (1.75%)  1
Asthma attack   1/55 (1.82%)  2 0/57 (0.00%)  0
Pneumonia   1/55 (1.82%)  1 0/57 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin rash   0/55 (0.00%)  0 1/57 (1.75%)  1
Dry skin   1/55 (1.82%)  1 0/57 (0.00%)  0
Vascular disorders     
Nosebleed   1/55 (1.82%)  1 0/57 (0.00%)  0
Superficial Thrombophlebitis   0/55 (0.00%)  0 1/57 (1.75%)  1
Indicates events were collected by systematic assessment
[1]
As terms for violating parole (for a positive cocaine UDS)
The weekly UDS (rather than thrice weekly as is customary in cocaine trials) design feature decreased our number of observations and statistical power, and did not provide us with a complete picture of cocaine use between weekly visits.
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: 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: NCT00280293     History of Changes
Other Study ID Numbers: 05T-704
First Submitted: January 19, 2006
First Posted: January 20, 2006
Results First Submitted: May 13, 2013
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013