Lamotrigine for Symptoms of Geriatric Bipolar Depression

Phase 3

Completed

• Conditions: Bipolar Disorder; Depression, Bipolar
• Interventions: Drug: Lamotrigine regular tablet formulation; Drug: Lamotrigine novel formulation

• Registration Number: NCT00621842
• Lead Sponsor: University Hospitals Cleveland Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-21
• Study First Posted: 2008-02-22
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2011-08-09
• Results First Submitted QC: 2011-09-15
• Results First Posted: 2011-10-25
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-08
• Last Update Posted: 2014-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-Label Lamotrigine Treatment	Lamotrigine novel formulation	-
Open-Label Lamotrigine Treatment	Lamotrigine regular tablet formulation	-

Primary Outcome Measures

Name	Time	Method
Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)	12 weeks	The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine	12 weeks
Number of Participants Who Fell at Least Once During the Study	12 weeks
Number of Participants Who Had a Fall That Required Medical Attention	12 weeks
Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)	12 weeks	The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.
Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP	12 weeks	The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Change in Body Weight From Baseline	12 weeks
Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)	12 weeks	The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)	12 weeks	The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)	12 weeks	The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)	12 weeks	The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)	12 weeks	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.

Trial Locations

Locations (5)

University Hospitals Case Medical Center/ Case Western Reserve University; 🇺🇸 Cleveland, Ohio, United States

Baylor College of Medicine/Michael E. DeBakey VAMC; 🇺🇸 Houston, Texas, United States

Weill Medical College of Cornell University; 🇺🇸 White Plains, New York, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic; 🇺🇸 Pittsburgh, Pennsylvania, United States