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Completed

NCT Number: NCT00621842

Lamotrigine for Symptoms of Geriatric Bipolar Depression

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lamotrigine regular tablet formulation

Drug

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 names: Lamictal

Lamotrigine novel formulation

Drug

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 names: Lamictal

Primary outcomes

  1. Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)

    Time frame: 12 weeks

    The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

Secondary outcomes

  1. Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)

    Time frame: 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.

  2. Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)

    Time frame: 12 weeks

    The minimum possible score is 0 and the maximum score is 78. A higher score implies a worse condition.

  3. Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)

    Time frame: 12 weeks

    The minimum possible score is 0 and the maximum score is 60. A higher score implies a worse condition.

  4. Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP

    Time frame: 12 weeks

    The minimum possible score is 1 and the maximum score is 7. A higher score implies a worse condition.

  5. Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)

    Time frame: 12 weeks

    The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.

  6. Change in Body Weight From Baseline

    Time frame: 12 weeks

  7. Number of Participants Who Fell at Least Once During the Study

    Time frame: 12 weeks

  8. Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)

    Time frame: 12 weeks

    The minimum possible score is 0 and the maximum score is 4. A higher score implies a worse condition.

  9. Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)

    Time frame: 12 weeks

    The minimum possible score is 0 and the maximum score is 5. A higher score implies a worse condition.

  10. Number of Participants Who Had a Fall That Required Medical Attention

    Time frame: 12 weeks

  11. Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • GlaxoSmithKline

Registry information

Official study title

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

Acronym: Geri-BD SAD

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Feb 22, 2008
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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