Lamotrigine for Symptoms of Geriatric Bipolar Depression

NCT00621842 | Completed Phase 3 Results DMC

• 3 other identifiers: L0971GSK110720IND 78,081
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 5

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.

Conditions

Bipolar Disorder; Depression, Bipolar

Keywords

Geriatric Psychiatry; Aged; lamotrigine

Outcome Measures

Primary Outcomes (1)

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

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

  12 weeks

Secondary Outcomes (11)

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (1)

Open-Label Lamotrigine Treatment

EXPERIMENTAL

Drug: Lamotrigine regular tablet formulation; Drug: Lamotrigine novel formulation

Interventions

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.

Also known as: Lamictal

Open-Label Lamotrigine Treatment

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.

Also known as: Lamictal

Open-Label Lamotrigine Treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (5)

Weill Medical College of Cornell University

White Plains, New York, 10605, United States

Location

University Hospitals Case Medical Center/ Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pittsburgh School of Medicine, Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Baylor College of Medicine/Michael E. DeBakey VAMC

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lamotrigine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Triazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Christopher Bialko
• Organization: Case Western Reserve University

Christopher.Bialko@UHhospitals.org

216-286-4362

Study Officials

• Martha Sajatovic, MD

  Case Western Reserve University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: February 12, 2008
• First Posted: February 22, 2008
• Study Start: January 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: December 30, 2014
• Results First Posted: October 25, 2011

Record last verified: 2014-12

Locations

US (5)