Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

16-week Comparative Effectiveness Trial of Lamotrigine vs. Fluoxetine for Bipolar Depression (FLAME)

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: NCT02389712
Recruitment Status : Terminated (Difficulties with recruitment)
First Posted : March 17, 2015
Results First Posted : June 11, 2019
Last Update Posted : June 19, 2019
Sponsor:
Collaborator:
J Willard and Alice S. Marriott Foundation
Information provided by (Responsible Party):
Mark Frye, Mayo Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Bipolar Disorder
Interventions Drug: Lamotrigine
Drug: Fluoxetine
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lamotrigine Fluoxetine
Hide Arm/Group Description

Subjects on this arm will be randomized to Lamotrigine.

Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.

Subjects on this arm will be randomized to Fluoxetine.

Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg.

Period Title: Overall Study
Started 1 1
Completed 1 1
Not Completed 0 0
Arm/Group Title Lamotrigine Fluoxetine Total
Hide Arm/Group Description

Subjects on this arm will be randomized to Lamotrigine.

Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.

Subjects on this arm will be randomized to Fluoxetine.

Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg.

Total of all reporting groups
Overall Number of Baseline Participants 1 1 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 1 participants 1 participants 2 participants
27
(27 to 27)
27
(27 to 27)
27
(27 to 27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 participants
Female
1
 100.0%
1
 100.0%
2
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 1 participants 2 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
0
   0.0%
0
   0.0%
0
   0.0%
White
1
 100.0%
1
 100.0%
2
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 1 participants 1 participants 2 participants
1 1 2
1.Primary Outcome
Title Inventory for Depressive Symptoms
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Study was terminated due to difficulties with recruitment
Arm/Group Title Lamotrigine Fluoxetine
Hide Arm/Group Description:

Subjects on this arm will be randomized to Lamotrigine.

Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.

Subjects on this arm will be randomized to Fluoxetine.

Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse Events were collected from baseline to week 16 week for both subjects.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lamotrigine Fluoxetine
Hide Arm/Group Description

Subjects on this arm will be randomized to Lamotrigine.

Lamotrigine: Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.

Subjects on this arm will be randomized to Fluoxetine.

Fluoxetine: Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg.

All-Cause Mortality
Lamotrigine Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Lamotrigine Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lamotrigine Fluoxetine
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1 (0.00%)   0/1 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Mark A. Frye, M.D.
Organization: Mayo Clinic
Phone: 507-255-7164
EMail: MFrye@mayo.edu
Layout table for additonal information
Responsible Party: Mark Frye, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02389712     History of Changes
Other Study ID Numbers: 13-003545-1
UL1TR000135 ( U.S. NIH Grant/Contract )
First Submitted: March 10, 2015
First Posted: March 17, 2015
Results First Submitted: May 21, 2019
Results First Posted: June 11, 2019
Last Update Posted: June 19, 2019