Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

NCT ID: NCT00305578

Last Updated: 2016-07-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-08-31
• Study Completion Date: 2011-12-31

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.

Conditions

Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

No active medication, only placebo

Memantine

Daily dose Memantine

Group Type: ACTIVE_COMPARATOR

Memantine

Intervention Type: 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.

Interventions

Memantine

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

Placebo

No active medication, only placebo

Intervention Type: DRUG

Other Intervention Names

Memantine or Namenda

Eligibility Criteria

Inclusion 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indiana University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amit Anand, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Indiana University Adult Psychiatric Clinic

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

0501-43

Identifier Type: -

Identifier Source: org_study_id