Lamotrigine Therapy in Geriatric Bipolar Depression
Information source: Mclean Hospital
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Depression
Intervention: Lamotrigine (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Mclean Hospital Official(s) and/or principal investigator(s):
Brent P Forester, MD, Principal Investigator, Affiliation: Mclean Hospital
Overall contact:
Susan Kim, BA, Phone: 617-855-2499, Email: skim@mclean.harvard.edu
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.
Clinical Details
Official title: Lamotrigine Therapy in the Treatment of Geriatric Bipolar Depression: An Evaluation of Markers of Cerebral Energy Metabolism
Study design: Basic Science, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Primary outcome: 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.
Secondary outcome: We will measure changes in lactate, glutamate, and NAA concentrations in individuals with bipolar depression before and after treatment with Lamotrigine.
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).
Eligibility
Minimum age: 60 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Susan Kim, BA, Phone: 617-855-2499, Email: skim@mclean.harvard.edu
McLean Hospital, Belmont, Massachusetts 02478, United States; Recruiting
Brent Forester, MD, Phone: 617-855-3622, Email: bforester@mclean.harvard.edu
Brent P Forester, MD, Principal Investigator
Additional Information
Starting date: April 2006
Ending date: December 2009
Last updated: July 18, 2008
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