Clinical trial NCT00621842: Lamotrigine for Symptoms of Geriatric Bipolar Depression
Official title: Open-label, Prospective Trial of Lamotrigine for Symptoms of Geriatric Bipolar Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Depression, Bipolar
Keywords: Geriatric Psychiatry
Aged
lamotrigine
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2008-02-22
Enrollment: 57
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of Adverse Effects With the Udvalg Fur Kliniske Undersogelser (UKU)
timeFrame: 12 weeks
measure: Change in Depressive Symptoms From Baseline Using the Hamilton Depression Rating Scale (GRID-HAM-D)
timeFrame: 12 weeks
measure: Change in Manic Symptoms From Baseline Using the Young Mania Rating Scale (YMRS)
timeFrame: 12 weeks
measure: Change From Baseline in Overall Clinical Diagnosis Using the CGI-BP
timeFrame: 12 weeks
measure: Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Simpson Angus Scale (SAS)
timeFrame: 12 weeks
measure: Change in Body Weight From Baseline
timeFrame: 12 weeks
measure: Number of Participants Who Fell at Least Once During the Study
timeFrame: 12 weeks
measure: Change in Appearance of Extrapyramidal Symptoms From Baseline Using the Abnormal Involuntary Movement Scale (AIMS)
timeFrame: 12 weeks
measure: Change in or Appearance of Extrapyramidal Symptoms From Baseline Using the Barnes Akathisia Scale (BAS)
timeFrame: 12 weeks
measure: Number of Participants Who Had a Fall That Required Medical Attention
timeFrame: 12 weeks
measure: Number of Participants Who Had a Fall That Required Medical Attention and Was Related to Lamotrigine
timeFrame: 12 weeks
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Weill Medical College of Cornell University
state: New York
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center/ Case Western Reserve University
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic
state: Pennsylvania
city: Houston
country: United States
facility: Baylor College of Medicine/Michael E. DeBakey VAMC
state: Texas
Study officials:
affiliation: Case Western Reserve University School of Medicine
name: Martha Sajatovic, MD
role: PRINCIPAL_INVESTIGATOR
References: