Lamotrigine Therapy in Geriatric Bipolar Depression - Full Text View

Sponsor:	Mclean Hospital
Information provided by:	Mclean Hospital
ClinicalTrials.gov Identifier:	NCT00720473

Purpose

We propose to study the efficacy and tolerability of lamotrigine in the treatment of older adults with bipolar depression and to compare measures of brain energy metabolism between older subjects with bipolar depression and healthy age-matched controls in order to better understand treatment response in geriatric bipolar depression.

Condition	Intervention
Bipolar Depression	Drug: Lamotrigine

Study Type:	Interventional
Study Design:	Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Lamotrigine Therapy in the Treatment of Geriatric Bipolar Depression: An Evaluation of Markers of Cerebral Energy Metabolism

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Lamotrigine

U.S. FDA Resources

Further study details as provided by Mclean Hospital:

Primary Outcome Measures:

We will measure response to treatment of bipolar depression (using the Montgomery Asberg Rating Scale, Wisconsin Card Sorting Test, Trails A and B, and the Stroop Tests) in older adults with bipolar disorder after an 8 week trial of Lamotrigine. [ Time Frame: 8 Week Trial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

We will measure changes in lactate, glutamate, and NAA concentrations in individuals with bipolar depression before and after treatment with Lamotrigine. [ Time Frame: 8 Week Trial ] [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	April 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Other Open Label Study	Drug: Lamotrigine Lamotrigine with dosage range from 25 mg to 200 mg per day.

Detailed Description:

We will use MRI techniques and neuropsychological testing to investigate potential markers of treatment response in elderly bipolar depressed patients receiving lamotrigine and age-matched, non-depressed controls.

We intend to test these hypotheses:

At least 50% of older subjects with bipolar depression will respond treatment with lamotrigine as evidenced by a 50% reduction on the Montgomery Asberg Rating Scale (MADRS). In addition, treatment with lamotrigine will be safe and well tolerated as evidenced by a drop-out rate of less than 10% due to adverse effects.
Compared with healthy age-matched, non-demented, non-depressed controls, subjects with geriatric bipolar depression will demonstrate abnormalities in cerebral energy metabolism as assessed by elevated levels of glutamate and lactate, and decreased levels of NAA, using 1H MRS at 4T.
Successful treatment with lamotrigine in geriatric bipolar depression will result in decreases in lactate and glutamate, and elevations in NAA.
Baseline measures of executive functioning and information processing speed (measured by performance on the Wisconsin Card Sorting Test (WCST), Trails A and B and Stroop tests) will be impaired in subjects with geriatric bipolar depression compared with healthy controls. These measures will improve with successful treatment with lamotrigine and correlate with improvements in markers of cerebral energy metabolism (lactate, glutamate, NAA).

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria (for Bipolar Subjects):

60 years or older
Meet DSM-IV diagnostic criteria for Bipolar Disorder, Current Episode Depressed
First episode of mania before the age of 50 (early-onset bipolar disorder)
Montgomery-Asberg Depression Rating Scale (MADRS) Score of greater or equal to 20.
Young Mania Rating Scale (YMRS) of less than or equal to 6.
Able to provide informed consent
Must speak English
Must be able to visit McLean Hospital for the screening visit and six study visits during the 8-week duration of the study.
Subjects may be taking other medications for bipolar depression including antidepressants, mood stabilizers and antipsychotic mediations prior to lamotrigine therapy, but may not have any dosage adjustments of these medications in the week before lamotrigine is added.

Exclusion Criteria (for Bipolar Subjects):

Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease.
History of seizure disorder
History or current diagnosis of the following psychiatric illnesses: any organic mental disorder (including dementia), schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, unipolar major depressive disorder, patients with substance dependence disorders, including alcohol, active within the last 12 months.
First episode of mania after the age of 50 (to exclude late-onset bipolar disorder)
History of multiple adverse drug reactions or allergy to the study drugs.
Use of medications that are excluded in this study (benzodiazepines, barbiturates; however, the use of non-benzodiazepine sedative hypnotics (such as zolpidem (Ambien)) may be used as needed except within 48 hours of the MRI scan)
Any of the exclusion criteria mentioned in the MRI risks section below

Inclusion Criteria (for Controls):

60 years or older
Able to provide informed consent
Must speak English
Women entering this study must be post-menopausal

Exclusion Criteria (for Controls):

- Same criteria for the Bipolar Depressed group with the exception of the "first episode of mania" which is not applicable.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720473

Contacts

Contact: Susan Kim, BA	617-855-2499	skim@mclean.harvard.edu
Contact: Brittany Jordan, BA	617-855-2499	bjordan@mclean.harvard.edu

Locations

United States, Massachusetts
McLean Hospital	Recruiting
Belmont, Massachusetts, United States, 02478
Contact: Brent Forester, MD 617-855-3622 bforester@mclean.harvard.edu
Principal Investigator: Brent P Forester, MD

Sponsors and Collaborators

Mclean Hospital

Investigators

Principal Investigator:

Brent P Forester, MD

Mclean Hospital

More Information

No publications provided

Responsible Party:	McLean Hospital ( Brent P. Forester MD )
Study ID Numbers:	2005-P-002493
Study First Received:	July 18, 2008
Last Updated:	September 15, 2009
ClinicalTrials.gov Identifier:	NCT00720473 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Mclean Hospital:

Bipolar depression
Elderly
Lamotrigine
Brain energy metabolism

Additional relevant MeSH terms:

Depression
Molecular Mechanisms of Pharmacological Action
Bipolar Disorder
Calcium Channel Blockers
Cardiovascular Agents
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms

Membrane Transport Modulators
Affective Disorders, Psychotic
Mental Disorders
Therapeutic Uses
Mood Disorders
Lamotrigine
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 04, 2010