Memantine Augmentation of Lamotrigine Incomplete-Response in Bipolar Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00305578
First received: September 14, 2005
Last updated: March 5, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Bipolar Depression
Drug: Memantine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Memantine Augmentation of Lamotrigine Incomplete Response in Bipolar Depression: A Randomized Placebo Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Improvement of scores on Hamilton Depression Rating Scale and Clinical Global Improvement Scale given once a week for eight weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Improvement of scores on Selective Reminding Test, Digit Span Test, Stroop Test, and Trail Making Test [ Time Frame: given every other week for 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: August 2005
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
Placebo daily
Drug: Placebo
No active medication, only placebo
Active Comparator: 2
Daily dose Memantine
Drug: 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.
Other Name: Memantine or Namenda

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00305578

Locations
United States, Indiana
Indiana University Adult Psychiatric Clinic
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Amit Anand, MD Indiana University School of Medicine
  More Information

No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00305578     History of Changes
Other Study ID Numbers: 0501-43
Study First Received: September 14, 2005
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Bipolar
Depression
Incomplete Response

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Affective Disorders, Psychotic
Memantine
Lamotrigine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Cardiovascular Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 19, 2014