This is a 12-week, open label trial of lamotrigine for older adults (age 60 and older) with type I or type II Bipolar depression. Non-demented older adults with Bipolar I or II depression, confirmed via the Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (DSM) - Patient edition (SCID-I/P) and meeting inclusion criteria for depressive symptom severity (score of 18 or greater on the Hamilton Depression Rating Scale/HAM-D-24) will receive add-on lamotrigine dosed to a target of 200 mg/day.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
Participants will have the option of trying a novel formulation of lamotrigine tablets instead of the lamotrigine regular formulation tablets. The dosing will remain the same regardless of which type of lamotrigine tablet is used. Day 0 lamotrigine regular tablet formulation or lamotrigine novel formulation will be initiated at 25 mg/day and upward titrated as per package insert to targeted maximum dose of 200 mg/day. Dosing will be reduced for individuals who experience adverse effects. Dosing will be modified as per package insert for lamotrigine for individuals on anticonvulsant compounds.
Weill Medical College of Cornell University
White Plains, New York, United States
University Hospitals Case Medical Center/ Case Western Reserve University
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States
Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time frame: 12 weeks
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)
Frequency of adverse effects was measured using the UKU. The total number of adverse effects assessed by the UKU is 49 plus one open-ended question about any adverse effects not assessed.
Time frame: 12 weeks
Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)
The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.
Time frame: 12 weeks
Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time frame: 12 weeks
Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Time frame: 12 weeks
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)
The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Time frame: 12 weeks
Change in Body Weight From Baseline
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Baylor College of Medicine/Michael E. DeBakey VAMC
Houston, Texas, United States
Time frame: 12 weeks
Number of Participants Who Fell at Least Once During the Study
Time frame: 12 weeks
Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)
The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Time frame: 12 weeks
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)
The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.
Time frame: 12 weeks
Number of Participants Who Had a Fall That Required Medical Attention
Time frame: 12 weeks
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine
Time frame: 12 weeks