NCT00280774

Brief Summary

The purpose of this research is to determine if patients on corticosteroids who are given memantine will show improvement in memory compared to those receiving placebo (an inactive substance). This research also seeks to determine if such patients, when given memantine, will experience improvement in manic/hypomanic symptoms (feelings of agitation, overexcitement, or hyperactivity) and/or depressive symptoms. Subjects will be randomized to a crossover trial of memantine and placebo for 8 weeks, followed by a 4 week washout and then 8 more weeks of the study medication. Memantine and placebo will start at 5 mg/day for one week, increased to 5 mg twice a day in the second week. During the third week patients will take 10 mg in the morning and 5 mg in the evening. At weeks 4-8, patients will take 10 mg twice a day. One 8 week course of study medication will be memantine and the other 8 week course of study medication will be placebo, both assigned in a random fashion.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

January 25, 2008

Status Verified

July 1, 2007

First QC Date

January 19, 2006

Last Update Submit

January 23, 2008

Conditions

Physiological Effects of Drugs

Keywords

corticosteroidprednisonememantinePatients who are taking a corticosteroid for apulmonary illnessrheumatic illnesskidney transplant

Outcome Measures

Primary Outcomes (1)

  • HVLT-R test total words recalled scores will be compared between baseline and exit of the active medication phase and placebo phase using a within subjects design and paired t-tests.

Interventions

MemantineDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients between (and including) ages 18-70 and taking at least 5 mg/day of prednisone equivalents for at least 3 months and anticipating continued treatment at the same dose for at least 20 additional weeks will be eligible for enrollment.

You may not qualify if:

  • Patients with a history of allergic reaction or other contraindication to memantine therapy or with other unstable medical conditions (e.g. recent myocardial infarction, diabetes with poor glycemic control) will not be allowed to participate.
  • Pregnant or nursing women or women of childbearing age who will not use University of Texas Southwestern (UTSW) Institutional Review Board (IRB) approved methods of avoiding pregnancy will be excluded from the study.
  • Those with a history of mental retardation, dementia, or other severe cognitive disorders will also be excluded from the study.
  • Patients with baseline RAVLT total words recalled normative score \> 55 will be excluded to avoid including persons with exceptionally good declarative memory at baseline.
  • Subjects who do not speak English will be excluded because many of the outcome measures used in this study are not validated in languages other than English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parkland Health and Hospital System (Asthma, Allergy, & Arthritis Clinics)

Dallas, Texas, 75235, United States

Location

Related Publications (1)

  • Brown ES, Vazquez M, Nakamura A. Randomized, placebo-controlled, crossover trial of memantine for cognitive changes with corticosteroid therapy. Biol Psychiatry. 2008 Oct 15;64(8):727-729. doi: 10.1016/j.biopsych.2008.05.010. Epub 2008 Jun 25.

    PMID: 18582848DERIVED

MeSH Terms

Interventions

Memantine

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Sherwood Brown, Ph.D., M.D.

    University of Texas Southwestern Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 23, 2006

Study Start

March 1, 2006

Study Completion

February 1, 2007

Last Updated

January 25, 2008

Record last verified: 2007-07

Locations

US(1)