Memantine or Riluzole Prophylaxis for Corticosteroid-induced Mood and Declarative Memory Changes

NCT00283309 | Terminated Phase 4

• 1 other identifier: 042005-018
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose is to determine if patients scheduled to receive prescription corticosteroid therapy for inflammatory illnesses who are given either memantine or riluzole pretreatment will show lesser declarative memory impairment than those receiving placebo. The exploratory purpose is to determine if patients scheduled to receive prescription corticosteroid therapy for inflammatory illnesses who are given memantine or riluzole pretreatment will show a smaller increase in manic/hypomanic symptom severity than those receiving placebo.

Conditions

Mood; Memory Deficit

Keywords

Corticosteroids; Riluzole; Memantine; Memory

Study Arms (3)

Memantine

ACTIVE COMPARATOR

Memantine is used to determine if patients given pretreatment to corticosteroid therapy for inflammatory illnesses will show lesser declarative memory impairment than those receiving placebo. Baseline 10mg x 3 days, then 10mg BID x 4 days.

Drug: Memantine

Placebo

PLACEBO COMPARATOR

Inactive ingredient matching the active medication in appearance

Drug: Memantine; Drug: Riluzole

Riluzole

ACTIVE COMPARATOR

Riluzole is given to patients receiving corticosteroid therapy for inflammatory illnesses pretreatment to determine if they show lesser declarative memory impairment than those receiving placebo. Baseline 50mg x 3 days, then 50mg BID x 4 days.

Drug: Riluzole

Interventions

Memantine DRUG

Memantine; Placebo

Riluzole DRUG

Placebo; Riluzole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• English speaking
• Able to provide informed consent
• Scheduled to receive a corticosteroid burst of at least 20 mg prednisone or equivalent for at least 7 days

You may not qualify if:

• History of allergic reaction to memantine and/or riluzole
• Pregnant or nursing women
• History of liver disease, myocardial infarction, renal failure, diabetes with poor glycemic control, or other unstable medical condition
• Mental retardation, dementia, or other severe cognitive disorder
• Prior prednisone therapy in the last 14 days
• Current alcohol/substance abuse/dependence

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Memory Disorders

Interventions

Memantine; Riluzole

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amantadine; Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Thiazoles; Sulfur Compounds; Benzothiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Sherwood Brown

  University of Texas, Southwestern Medical Center at Dallas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD/PhD

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 27, 2006
• Study Start: November 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: April 23, 2013

Record last verified: 2013-04

Locations

US (1)