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Lamotrigine Therapy in Geriatric Bipolar Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00720473
First received: July 18, 2008
Last updated: June 7, 2016
Last verified: June 2016
Results First Received: November 26, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Bipolar Depression
Intervention: Drug: Lamotrigine

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
A: BPD Subjects

Open Label Study

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

B: Healthy Control No Intervention

Participant Flow:   Overall Study
    A: BPD Subjects     B: Healthy Control  
STARTED     45     24  
COMPLETED     15     16  
NOT COMPLETED     30     8  



  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.
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.

Reporting Groups
  Description
BPD Subjects

Open Label Study

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

Control Subjects Age matched controls without BPD
Total Total of all reporting groups

Baseline Measures
    BPD Subjects     Control Subjects     Total  
Number of Participants  
[units: participants]
  23     14     37  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     17     7     24  
>=65 years     6     7     13  
Age  
[units: years]
Mean (Standard Deviation)
  62.0  (5.9)     67.5  (8.8)     64.6  (7.4)  
Gender  
[units: participants]
     
Female     9     7     16  
Male     14     7     21  
Region of Enrollment  
[units: participants]
     
United States     23     14     37  



  Outcome Measures
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1.  Primary:   Mean Glutamine to Creatine Ratio by Diagnosis at Baseline   [ Time Frame: Baseline ]

2.  Primary:   Mean Glutamate to Creatine Ratio by Diagnosis at Baseline   [ Time Frame: Baseline ]

3.  Primary:   Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline   [ Time Frame: Baseline ]

4.  Primary:   Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline   [ Time Frame: Baseline ]

5.  Primary:   Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up   [ Time Frame: 8 Weeks ]

6.  Primary:   Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up   [ Time Frame: 8 weeks ]

7.  Primary:   Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up   [ Time Frame: 8 weeks ]

8.  Primary:   Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up   [ Time Frame: 8 Weeks ]

9.  Primary:   Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up   [ Time Frame: 8 weeks ]

10.  Primary:   Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up   [ Time Frame: 8 weeks ]

11.  Primary:   Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline   [ Time Frame: Baseline ]

12.  Primary:   Means of MADRS Scores at 8 Weeks   [ Time Frame: 8 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
Limited data was available for associating changes in MADRS scores with metabolite changes (22 regions from 11 participants with BPD).


  More Information
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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:  
Name/Title: Dr. Brent Forester
Organization: McLean Hospital
phone: (617) 855-3622
e-mail: bforester@partners.org



Responsible Party: Brent Forester, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00720473     History of Changes
Other Study ID Numbers: 2005-P-002493
Study First Received: July 18, 2008
Results First Received: November 26, 2013
Last Updated: June 7, 2016
Health Authority: United States: Food and Drug Administration