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Lamotrigine for Symptoms of Geriatric Bipolar Depression (Geri-BD SAD)

Primary Purpose

Bipolar Disorder, Depression, Bipolar

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lamotrigine regular tablet formulation
Lamotrigine novel formulation
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Geriatric Psychiatry, Aged, lamotrigine

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weill Medical College of Cornell University
  • University Hospitals Case Medical Center/ Case Western Reserve University
  • University of Pennsylvania
  • University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
  • Baylor College of Medicine/Michael E. DeBakey VAMC

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Lamotrigine Treatment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
Change in Body Weight From Baseline
Number of Participants Who Fell at Least Once During the Study
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.
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.
Number of Participants Who Had a Fall That Required Medical Attention
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine

Full Information

First Posted
February 12, 2008
Last Updated
December 8, 2014
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00621842
Brief Title
Lamotrigine for Symptoms of Geriatric Bipolar Depression
Acronym
Geri-BD SAD
Official Title
Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Depression, Bipolar
Keywords
Geriatric Psychiatry, Aged, lamotrigine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
57 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Lamotrigine Treatment
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Lamotrigine regular tablet formulation
Other Intervention Name(s)
Lamictal
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Lamotrigine novel formulation
Other Intervention Name(s)
Lamictal
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
Description
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)
Description
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
Title
Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)
Description
The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.
Time Frame
12 weeks
Title
Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)
Description
The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.
Time Frame
12 weeks
Title
Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP
Description
The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.
Time Frame
12 weeks
Title
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)
Description
The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Time Frame
12 weeks
Title
Change in Body Weight From Baseline
Time Frame
12 weeks
Title
Number of Participants Who Fell at Least Once During the Study
Time Frame
12 weeks
Title
Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)
Description
The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.
Time Frame
12 weeks
Title
Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)
Description
The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.
Time Frame
12 weeks
Title
Number of Participants Who Had a Fall That Required Medical Attention
Time Frame
12 weeks
Title
Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martha Sajatovic, MD
Organizational Affiliation
Case Western Reserve University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Medical College of Cornell University
City
White Plains
State/Province
New York
ZIP/Postal Code
10605
Country
United States
Facility Name
University Hospitals Case Medical Center/ Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Baylor College of Medicine/Michael E. DeBakey VAMC
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Lamotrigine for Symptoms of Geriatric Bipolar Depression

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