Lamotrigine for Symptoms of Geriatric Bipolar Depression
Information source: University Hospitals of Cleveland
Information obtained from ClinicalTrials.gov on October 19, 2009
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: Recruiting
Sponsored by: University Hospitals of Cleveland Official(s) and/or principal investigator(s):
Martha Sajatovic, MD, Principal Investigator, Affiliation: Case Western Reserve University School of Medicine
Overall contact:
Kristin Cassidy, MA, Phone: 216-844-2834, Email: kristin.cassidy@uhhospitals.org
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 standardized diagnostic interview assessment (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: Treatment, Non-Randomized, Open Label, Single Group Assignment
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 standardized rating scales and 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 SAS, BAS, and AIMS scales. Change in body weight from baseline Spontaneous reports of adverse effects
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
Kristin Cassidy, MA, Phone: 216-844-2834, Email: kristin.cassidy@uhhospitals.org
Weill Medical College of Cornell University, White Plains, New York 10605, United States; Recruiting
Laurie Davan, BA, Phone: 914-682-9100, Ext: 2570, Email: lad9011@med.cornell.edu
Robert Young, MD, Principal Investigator
Martha Bruce, PhD, MPH, Sub-Investigator
University Hospitals Case Medical Center/ Case Western Reserve University, Cleveland, Ohio 44106, United States; Recruiting
Joy Kettren, MA, Phone: 216-844-2102, Email: Geropsychiatry.Research@UHhospitals.org
Carrie Rodd, MA, Phone: 216-286-4361, Email: Geropsychiatry.Research@UHhospitals.org
Martha Sajatovic, MD, Principal Investigator
Philipp Dines, MD, PhD, Sub-Investigator
Luis Ramirez, MD, Sub-Investigator
University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Nancy McLaughlin, Phone: 412-246-6008, Email: mclaughlinn@upmc.edu
James Emanuel, Phone: 412-246-6096, Email: emanuelje@upmc.edu
Ariel Gildengers, MD, Principal Investigator
Benoit Mulsant, MD, Sub-Investigator
University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Marna Barrett, PhD, Phone: 215-746-6414, Email: msb@mail.med.upenn.edu
Laszlo Gyulai, MD, Principal Investigator
Baylor College of Medicine/Michael E. DeBakey VAMC, Houston, Texas 77030, United States; Recruiting
Barbara Kertz, Phone: 713-794-8815, Email: bkertz@bcm.tmc.edu
Rayan Al Jurdi, MD, Principal Investigator
Mark Kunik, MD, Principal Investigator
Theron C Bowers Jr., MD, Sub-Investigator
Susan L Rollins, PA-C, Sub-Investigator
Additional Information
Starting date: January 2008
Ending date: December 2009
Last updated: February 24, 2009
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