Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

NCT00305578 | Completed Phase 4 Results DMC

• 1 other identifier: 0501-43
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate whether addition of memantine to bipolar depression patients who have had an incomplete response to lamotrigine (Lamictal) which is frequently used to treat bipolar depression in the clinical setting. At present, memantine is approved for use in the treatment of Alzheimer's disease or dementia, but not for use for the treatment of bipolar depression. Subjects will be asked to participate because they are suffering from bipolar depression associated and have had an inadequate response to lamotrigine. Subjects will have to be on at least 100 mg per day, for at least 4 weeks.

Conditions

Bipolar Depression

Keywords

Bipolar; Depression; Incomplete Response

Outcome Measures

Primary Outcomes (1)

• Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)

  Scale for measurement of depression severity. Total of scale is used. Total range is from 0 - 50 with higher score signifying higher severity of depression. Outcome measure is change in score from baseline to 8 wks.

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo daily

Drug: Placebo

Memantine

ACTIVE COMPARATOR

Daily dose Memantine

Drug: Memantine

Interventions

Memantine DRUG

Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study.

Also known as: Memantine or Namenda

Memantine

Placebo DRUG

No active medication, only placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Adult Psychiatric Clinic

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Depression

Interventions

Memantine

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Limitations and Caveats

Small number of subjects

Results Point of Contact

• Title: Dr. Amit Anand
• Organization: Indiana University

aanand@iupui.edu

Study Officials

• Amit Anand, MD

  Indiana University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2005
• First Posted: March 22, 2006
• Study Start: August 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2011
• Last Updated: July 18, 2016
• Results First Posted: November 2, 2015

Record last verified: 2016-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)