search
Back to results

Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Memantine
Placebo
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression focused on measuring Bipolar, Depression, Incomplete Response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated with at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating > 15; 4) give informed consent as approved by local IRB; 5) if on other antidepressants or mood stabilizers on stable dose for the past 4 weeks. Exclusion Criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffective disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to be pregnant or not using adequate contraception; 6) satisfy criteria for substance dependence within 6 months prior to start of the study; and 7) on any medication with significant adverse interaction with either lamotrigine or memantine.

Sites / Locations

  • Indiana University Adult Psychiatric Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Memantine

Arm Description

Placebo daily

Daily dose Memantine

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 14, 2005
Last Updated
June 16, 2016
Sponsor
Indiana University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00305578
Brief Title
Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression
Official Title
Memantine Augmentation of Lamotrigine Incomplete Response in Bipolar Depression: A Randomized Placebo Controlled Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Hypothesis/Objectives: H1: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement on the Hamilton Depression Rating Scale (HDRS) and Clinical Global Improvement (CGI) scale compared to patients augmented with placebo. H2: Lamotrigine inadequate-response patients augmented with memantine for 8 weeks will have significantly greater improvement of scores on the Selective Reminding Test (SRT), the Digit Span Test, the Stroop Test, and Trail Making Test (TMT) than patients augmented with placebo. Study Population: We will study 40 bipolar disorder depressed (BDD) outpatients (20 in each arm) recruited from the outpatient Mood Disorders Clinic and by advertisement.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression
Keywords
Bipolar, Depression, Incomplete Response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo daily
Arm Title
Memantine
Arm Type
Active Comparator
Arm Description
Daily dose Memantine
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Memantine or Namenda
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
No active medication, only placebo
Primary Outcome Measure Information:
Title
Change in 17-item Hamilton Depression Rating Scale From Baseline to 8 Weeks (Baseline - 8 Wks)
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:: 1) age 18 - 65; 2) satisfy DSM-IV-TR criteria for Bipolar Disorder and Major Depressive Episode; 3) Lamotrigine Inadequate-Response: Defined as already treated with at least 100 mg of lamotrigine for at least 4 weeks but 17 item HDRS rating > 15; 4) give informed consent as approved by local IRB; 5) if on other antidepressants or mood stabilizers on stable dose for the past 4 weeks. Exclusion Criteria:1) comorbid psychotic disorder such as schizophrenia or schizoaffective disorder; 2) significant suicidal or homicidal risk; 3) clinically significant medical illness; 4) allergy or intolerance to lamotrigine or memantine; 5) pregnancy, planning to be pregnant or not using adequate contraception; 6) satisfy criteria for substance dependence within 6 months prior to start of the study; and 7) on any medication with significant adverse interaction with either lamotrigine or memantine.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amit Anand, MD
Organizational Affiliation
Indiana University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Adult Psychiatric Clinic
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

We'll reach out to this number within 24 hrs