Lamotrigine for Symptoms of Geriatric Bipolar Depression

Study Overview
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Brief Summary
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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.

Official Title
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Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression

Conditions
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Bipolar Disorder, Depression, Bipolar

Intervention / Treatment
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* Drug: Lamotrigine regular tablet formulation
* Drug: Lamotrigine novel formulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 60 Years or older BP Disorder-I or II: Depressive episode (DSM -IV-TR; SCID-I/P) HAM-D score > 18 (GRID-HAM-D 24-item version) Availability of an Informant is encouraged but not required for study participation Exclusion Criteria: Chronic psychotic conditions, ie. schizophrenia, schizoaffective disorder, delusional disorder Contraindication to lamotrigine (Physician interview, medical assessment) Documented history of intolerance to lamotrigine Patients who have previously failed to respond to at least 12 weeks of treatment with lamotrigine Active substance dependence (SCID-I/P) or substance-related safety issues or PI concerns Mood Disorder Due to a General Medical Condition or Treatment (Physician interview) Rapid cycling (Physician interview): As defined in DSM-IV: At least 4 episodes of mood disturbance in the previous 12 months that meet criteria for a Major Depressive, Manic, Mixed or Hypomanic Episode. Episodes are distinguished either by partial or full remission for at least 2 months or by a switch to an episode of opposite polarity Dementia (by DSM-IV or brain degenerative diseases; Physician interview); Inability to communicate in English (i.e., interview cannot be conducted without an interpreter; subject largely unable to understand questions and cannot respond in English) Clinically significant sensory impairment (i.e., cannot see well enough to read consent or visually-presented material; cannot hear well enough to cooperate with interview; Physician interview) Recent history of cardiovascular, peripheral vascular events or stroke High risk for suicide (e.g., active SI or current intent or plan) Inpatient status

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-Label Lamotrigine Treatment<br> | Drug: Lamotrigine regular tablet formulation<br>* 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.<br>* Other names: Lamictal;Drug: Lamotrigine novel formulation<br>* 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.<br>* Other names: Lamictal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 12 weeks | 
| Change in Body Weight From Baseline |  | 12 weeks | 
| Number of Participants Who Fell at Least Once During the Study |  | 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. | 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. | 12 weeks | 
| Number of Participants Who Had a Fall That Required Medical Attention |  | 12 weeks | 
| Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine |  | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Geriatric Psychiatry, Aged, lamotrigine