Lamotrigine Therapy in Geriatric Bipolar Depression

NCT00720473 | Completed Results DMC

• 1 other identifier: 2005-P-002493
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Depression

Keywords

Bipolar depression; Elderly; Lamotrigine; Brain energy metabolism

Outcome Measures

Primary Outcomes (12)

• Mean Glutamine to Creatine Ratio by Diagnosis at Baseline

  Baseline

• Mean Glutamate to Creatine Ratio by Diagnosis at Baseline

  Baseline

• Mean N-Acetyl Aspartate (NAA) to Creatine Ratio by Diagnosis at Baseline

  Baseline

• Associations Between Depression Symptom Severity and Glutamate to Creatine Ratio at Baseline

  Estimated changes in least squares mean in the metabolite ratio per 10-point increase in MADRS score. The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.

  Baseline

• Estimated Change in Least Squares Mean in Glutamate to Creatine Ratio Between Baseline and Follow-up

  Follow-up Least Squares Mean - Baseline Least Squares Mean

  8 Weeks

• Estimated Change in Least Squares Mean in the Glutamine to Creatine Ratio Between Baseline and Follow-up

  Follow-up Least Squares Mean - Baseline Least Squares Mean

  8 weeks

• Estimated Change in Least Squares Mean in the NAA to Creatine Ratio Between Baseline and Follow-up

  Follow-up Least Squares Mean - Baseline Least Squares Mean

  8 weeks

• Association of MADRS Changes With Glutamate to Creatine Ratio Changes From Baseline to Follow-up

  Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. The MADRS minimum score is 0 and maximum is 60, with 60 being the most depressed score. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.

  8 Weeks

• Associations of MADRS Changes With Glutamine to Creatine Ratio Changes From Baseline to Follow-up

  Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.

  8 weeks

• Associations of MADRS Changes With NAA to Creatine Ratio Changes From Baseline to Follow-up

  Estimated least squares mean metabolite ratio changes with a 10-point decrease in MADRS score. MADRS minimum score is 0 and maximum is 60, with 60 being most depressed. Estimate was from linear regression models controlling for age and sex. The change is across regions, parieto-occipital and anterior cingulate cortex.

  8 weeks

• Mean Montgomery Asberg Depression Rating Scale (MADRS) Score at Baseline

  The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.

  Baseline

• Means of MADRS Scores at 8 Weeks

  The minimum MADRS score is 0 and the maximum is 60, with 60 being the most depressed.

  8 Weeks

Study Arms (2)

A: Other

OTHER

Open Label Study

Drug: Lamotrigine

B: Healthy Controls

NO INTERVENTION

Interventions

Lamotrigine DRUG

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

Also known as: Lamictal

A: Other

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)
• years or older
• Able to provide informed consent
• Must speak English
• Women entering this study must be post-menopausal
• \- Same criteria for the Bipolar Depressed group with the exception of the "first episode of mania" which is not applicable.

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, 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

Limitations and Caveats

Limited data was available for associating changes in MADRS scores with metabolite changes (22 regions from 11 participants with BPD).

Results Point of Contact

• Title: Dr. Brent Forester
• Organization: McLean Hospital

bforester@partners.org

(617) 855-3622

Study Officials

• Brent P Forester, MD

  Mclean Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Mood Disorders Division, Geriatric Psychiatry Research Program

Study Record Dates

• First Submitted: July 18, 2008
• First Posted: July 22, 2008
• Study Start: April 1, 2006
• Primary Completion: July 1, 2011
• Study Completion: December 1, 2011
• Last Updated: February 1, 2017
• Results First Posted: July 21, 2016

Record last verified: 2017-01

Locations

US (1)