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| Sponsored by: |
Indiana University School of Medicine |
|---|---|
| Information provided by: | Indiana University |
| ClinicalTrials.gov Identifier: | NCT00305578 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | Memantine Augmentation of Lamotrigine Incomplete Response in Bipolar Depression: A Randomized Placebo Controlled Clinical Trial |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2005 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Placebo Comparator
Placebo daily
|
Drug: Placebo
No active medication, only placebo
|
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2: Active Comparator
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 toleranceand will be kept at that level for the rest of the study. This is an 8 week study.
|
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 |
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| Contact: Abi French, MS | 317-274-0318 | abdfrenc@iupui.edu |
| Contact: Amit Anand, MD | 317-274-7422 |
| United States, Indiana | |
| Indiana University Adult Psychiatric Clinic | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Abi French, MS 317-274-0318 abdfrenc@iupui.edu | |
| Principal Investigator: | Amit Anand, MD | Indiana University School of Medicine |
More Information
| Responsible Party: | Indiana University School of Medicine, Department of Psychiatry ( Amit Anand ) |
| Study ID Numbers: | 0501-43 |
| Study First Received: | September 14, 2005 |
| Last Updated: | July 31, 2009 |
| ClinicalTrials.gov Identifier: | NCT00305578 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Bipolar Depression Incomplete Response |
|
Excitatory Amino Acids Neurotransmitter Agents Depression Bipolar Disorder Calcium Channel Blockers Cardiovascular Agents Depressive Disorder Behavioral Symptoms Calcium, Dietary |
Affective Disorders, Psychotic Dopamine Mental Disorders Mood Disorders Lamotrigine Memantine Psychotic Disorders Dopamine Agents Anticonvulsants |
|
Neurotransmitter Agents Depression Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Bipolar Disorder Physiological Effects of Drugs Calcium Channel Blockers Antiparkinson Agents Excitatory Amino Acid Agents Cardiovascular Agents Depressive Disorder Pharmacologic Actions |
Behavioral Symptoms Membrane Transport Modulators Affective Disorders, Psychotic Mental Disorders Therapeutic Uses Mood Disorders Lamotrigine Memantine Dopamine Agents Central Nervous System Agents Anticonvulsants Excitatory Amino Acid Antagonists |
