Lamotrigine for Symptoms of Geriatric Bipolar Depression

Bipolar Disorder Clinical Trial

— Geri-BD SAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00621842
• Other study ID #: L0971
• Secondary ID: GSK110720IND 78,
• Status: Completed
• Phase: Phase 3
• First received: February 12, 2008
• Last updated: December 8, 2014
• Start date: January 2008
• Est. completion date: March 2010

Study information

• Verified date: December 2014
• Source: University Hospital Case Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depression, Bipolar
• Depressive Disorder

Intervention

Drug:
• Lamotrigine regular tablet formulation
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.
• Lamotrigine novel formulation
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.

Locations

Country	Name	City	State
United States	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	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic	Pittsburgh	Pennsylvania
United States	Weill Medical College of Cornell University	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Case Medical Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Change in Body Weight From Baseline		12 weeks	No
Secondary	Number of Participants Who Fell at Least Once During the Study		12 weeks	Yes
Secondary	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	No
Secondary	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	No
Secondary	Number of Participants Who Had a Fall That Required Medical Attention		12 weeks	Yes
Secondary	Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine		12 weeks	Yes