Lamotrigine add-on Therapy for Bipolar Disorder and Cocaine Dependency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT00280293
First received: January 19, 2006
Last updated: July 30, 2013
Last verified: July 2013
Results First Received: May 13, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Bipolar Disorder
Cocaine Dependence
Interventions: Drug: Lamotrigine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
Lamotrigine 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 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.

Participant Flow:   Overall Study
    Lamotrigine     Placebo  
STARTED     55     57  
COMPLETED     29     34  
NOT COMPLETED     26     23  
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  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Lamotrigine 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 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 Total of all reporting groups

Baseline Measures
    Lamotrigine     Placebo     Total  
Number of Participants  
[units: participants]
  55     57     112  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     55     57     112  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  45.1  ± 7.3     43.5  ± 10.0     44.3  ± 8.8  
Gender  
[units: participants]
     
Female     23     22     45  
Male     32     35     67  
Region of Enrollment  
[units: participants]
     
United States     55     57     112  



  Outcome Measures
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1.  Primary:   Days of Cocaine Use   [ Time Frame: 10 weeks ]

2.  Primary:   Positive Urine Drug Screens   [ Time Frame: 10 weeks ]

3.  Secondary:   Depression Score on the Hamilton Rating Scale For Depression   [ Time Frame: 10 weeks ]

4.  Secondary:   Dollars Spent   [ Time Frame: 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. E. Sherwood Brown
Organization: UT Southwestern Medical Center
phone: 214-645-6950
e-mail: sherwood.brown@utsouthwestern.edu


No publications provided


Responsible Party: Sherwood Brown, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT00280293     History of Changes
Other Study ID Numbers: 05T-704
Study First Received: January 19, 2006
Results First Received: May 13, 2013
Last Updated: July 30, 2013
Health Authority: United States: Food and Drug Administration