NCT00183729

Brief Summary

This study will evaluate the effectiveness of memantine in improving rehabilitation outcomes and preventing major depressive disorder in older adults who have been admitted to a rehabilitation hospital for a hip fracture or cardiopulmonary condition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Aug 2005

Typical duration for phase_4 depression

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

Study Start

First participant enrolled

August 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2009

Completed
7.5 years until next milestone

Results Posted

Study results publicly available

December 15, 2016

Completed
Last Updated

January 17, 2018

Status Verified

December 1, 2017

Enrollment Period

3.8 years

First QC Date

September 14, 2005

Results QC Date

July 1, 2016

Last Update Submit

December 18, 2017

Conditions

Depression

Keywords

Major depressive disorderRehabilitatingElderlyApathy

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms

    Hamilton depression rating scale ; scale ranges 0 (no symptoms) to 52 (severe depression)

    week 0, week 12

Secondary Outcomes (2)

  • Incidence of Major Depressive Disorder

    week 12

  • Functional Recovery

    week 0, week 12

Study Arms (2)

Memantine (1)

EXPERIMENTAL

Memantine for 12 weeks

Drug: Memantine

Placebo (2)

PLACEBO COMPARATOR

Placebo for 12 weeks

Other: Placebo

Interventions

MemantineDRUG

Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day.

Also known as: Namenda
Memantine (1)
PlaceboOTHER

Placebo distribution is planned to mimic the active drug.

Placebo (2)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Admission to a skilled nursing facility for rehabilitation within 3 months of recent disabling medical event (e.g., hip fracture)
  • Medically stable (e.g., no active seizures, delirium, unstable pulse/blood pressure)

You may not qualify if:

  • Aphasia or cognitive impairments sufficiently severe to prevent valid assessment (e.g., a score of less than 22 on the Mini Mental State Examination)
  • Current major depressive episode
  • History of or current psychosis or mania
  • Current substance or alcohol abuse or dependence (within 3 months of study entry)
  • Current use of memantine
  • Sensitivity or contraindication to memantine
  • End-stage kidney, liver, heart, or lung disease
  • Recent hemorrhagic stroke
  • A FIM score of greater than 70 (on a 91 point scale)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Lenze EJ, Skidmore ER, Begley AE, Newcomer JW, Butters MA, Whyte EM. Memantine for late-life depression and apathy after a disabling medical event: a 12-week, double-blind placebo-controlled pilot study. Int J Geriatr Psychiatry. 2012 Sep;27(9):974-80. doi: 10.1002/gps.2813. Epub 2011 Dec 16.

    PMID: 22173933RESULT

MeSH Terms

Conditions

DepressionDepressive Disorder, MajorLethargy

Interventions

Memantine

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AmantadineAdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Eric Lenze
Organization
Washington University School of Medicine
lenzee@wustl.edu
314-362-1671

Study Officials

  • Eric J. Lenze, MD

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 16, 2005

Study Start

August 1, 2005

Primary Completion

June 1, 2009

Study Completion

June 1, 2009

Last Updated

January 17, 2018

Results First Posted

December 15, 2016

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

study has small sample size and is unlikely to be useful for data sharing efforts; however, interested researchers can contact the first author via email.

Locations

US(1)