N/A N=69 Basic Science

Lamotrigine Therapy in Geriatric Bipolar Depression

Bipolar Depression

Bottom Line

View on ClinicalTrials.gov: NCT00720473 ↗

Enrolled (actual)

Serious AEs

2.9%

Results posted

Jul 2016

Primary outcome: Primary: Mean Glutamine to Creatine Ratio by Diagnosis at Baseline — .34; .36 mean serum Glutamine to Creatine ratio

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lamotrigine (Drug)
Age: Adult, Older Adult · 60+ yrs
Sex: All
Sponsor: Mclean Hospital
Primary completion: Jul 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Mean Glutamine to Creatine Ratio by Diagnosis at Baseline	.34; .36	—
PRIMARY Mean Glutamate to Creatine Ratio by Diagnosis at Baseline	.96; .85	—
PRIMARY Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline	0.97; 0.84	—
PRIMARY Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline	0.18	—
PRIMARY Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up	0.00; -0.12	—
PRIMARY Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up	0.02; 0.08	—
PRIMARY Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up	0.06; -0.03	—
PRIMARY Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up	-.007	—
PRIMARY Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up	0.04	—
PRIMARY Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up	0.05	—
PRIMARY Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline	24.78; 1.03	—
PRIMARY Means of MADRS Scores at 8 Weeks	18.31; 1.38	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00720473). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.