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Lamotrigine for Symptoms of Geriatric Bipolar Depression

Information source: University Hospital Case Medical Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Bipolar Disorder; Depression, Bipolar

Intervention: Lamotrigine regular tablet formulation (Drug); Lamotrigine novel formulation (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University Hospital Case Medical Center

Official(s) and/or principal investigator(s):
Martha Sajatovic, MD, Principal Investigator, Affiliation: Case Western Reserve University School of Medicine

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.

Clinical Details

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

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

Primary outcome: Assessment of Change in Depressive Symptoms From Baseline on the Montgomery Asberg Depression Rating Scale (MADRS)

Secondary outcome:

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

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

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

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

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

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)

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

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

Eligibility

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Weill Medical College of Cornell University, White Plains, New York 10605, United States

University Hospitals Case Medical Center/ Case Western Reserve University, Cleveland, Ohio 44106, United States

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States

Baylor College of Medicine/Michael E. DeBakey VAMC, Houston, Texas 77030, United States

Additional Information

Starting date: January 2008
Last updated: December 8, 2014

Page last updated: August 23, 2015

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