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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Martha Sajatovic, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT00621842
First received: February 12, 2008
Last updated: September 15, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Bipolar Disorder
Depression, Bipolar
Drug: Lamotrigine regular tablet formulation
Drug: Lamotrigine novel formulation
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression

Resource links provided by NLM:


Further study details as provided by University Hospital Case Medical Center:

Primary Outcome Measures:
  • Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Number of Participants Who Fell at Least Once During the Study [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 57
Study Start Date: January 2008
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Open-Label Lamotrigine Treatment 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.
Other Name: Lamictal
Drug: 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.

Other Name: Lamictal

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00621842

Locations
United States, New York
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
United States, Ohio
University Hospitals Case Medical Center/ Case Western Reserve University
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Baylor College of Medicine/Michael E. DeBakey VAMC
Houston, Texas, United States, 77030
Sponsors and Collaborators
University Hospital Case Medical Center
GlaxoSmithKline
Investigators
Principal Investigator: Martha Sajatovic, MD Case Western Reserve University School of Medicine
  More Information

No publications provided

Responsible Party: Martha Sajatovic, Professor of Psychiatry, University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT00621842     History of Changes
Other Study ID Numbers: L0971, GSK110720, IND 78,081
Study First Received: February 12, 2008
Results First Received: August 9, 2011
Last Updated: September 15, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University Hospital Case Medical Center:
Geriatric Psychiatry
Aged
lamotrigine

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Affective Disorders, Psychotic
Behavioral Symptoms
Mental Disorders
Mood Disorders
Anticonvulsants
Lamotrigine
Calcium Channel Blockers
Cardiovascular Agents
Central Nervous System Agents
Excitatory Amino Acid Agents
Excitatory Amino Acid Antagonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 24, 2014