Lamotrigine Therapy in Geriatric Bipolar Depression

NCT ID: NCT00720473

Last Updated: 2017-02-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2011-12-31

Brief Summary

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.

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:

1. 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.

2. 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.

3. Successful treatment with lamotrigine in geriatric bipolar depression will result in decreases in lactate and glutamate, and elevations in NAA.

4. 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).

Conditions

Bipolar Depression

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

A: Other

Open Label Study

Group Type: OTHER

Lamotrigine

Intervention Type: DRUG

Lamotrigine with dosage range from 25 mg to 200 mg per day.

B: Healthy Controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lamotrigine

Lamotrigine with dosage range from 25 mg to 200 mg per day.

Intervention Type: DRUG

Other Intervention Names

Lamictal

Eligibility Criteria

Inclusion Criteria

• 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.

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

Exclusion Criteria

• 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)

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Brent Forester

Director, Mood Disorders Division, Geriatric Psychiatry Research Program

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brent P Forester, MD

Role: PRINCIPAL_INVESTIGATOR

Mclean Hospital

Locations

McLean Hospital

Belmont, Massachusetts, United States

Countries

United States

Other Identifiers

2005-P-002493

Identifier Type: -

Identifier Source: org_study_id