NCT00071643

Brief Summary

This study will evaluate the effectiveness of both drug and non-drug treatments in preventing depression after a stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
201

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2002

Longer than P75 for not_applicable depression

Geographic Reach
1 country

3 active sites

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

September 1, 2002

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 29, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 30, 2003

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

September 5, 2017

Status Verified

August 1, 2017

Enrollment Period

6.2 years

First QC Date

October 29, 2003

Last Update Submit

August 31, 2017

Conditions

DepressionCerebrovascular Accident

Keywords

Stroke

Outcome Measures

Primary Outcomes (1)

  • Incidence of depressive disorders in the study population

    Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

Secondary Outcomes (3)

  • Functional Independence Measure

    Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18

  • Stroke Impact Scale

    Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18

  • Neurocognitive tests of executive functions and speed of information processing

    Measured at baseline and after 12 months

Study Arms (3)

1 Problem Solving Therapy

EXPERIMENTAL

Participants will receive problem solving therapy.

Behavioral: Problem Solving Therapy

2. Escitalopram

EXPERIMENTAL

Participants will receive escitalopram.

Drug: Escitalopram

3 Placebo

PLACEBO COMPARATOR

Participants will receive placebo.

Other: Placebo

Interventions

Problem Solving TherapyBEHAVIORAL

Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.

1 Problem Solving Therapy
EscitalopramDRUG

Participants will receive escitalopram, a selective serotonin reuptake inhibitor.

Also known as: Lexapro
2. Escitalopram
PlaceboOTHER

Participants will receive a placebo pill.

3 Placebo

Eligibility Criteria

Age31 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stroke within the last 120 days

You may not qualify if:

  • DSM (Diagnostic and Statistical Manual) IV criteria for major or minor depressive disorder
  • Heart, respiratory, kidney, or liver failure; severely disabling musculoskeletal disorder; or cancer
  • Diagnosis of neurodegenerative disorders such as Parkinson's disease, Alzheimer's disease, Multiple System Atrophy, or Huntington's disease
  • Pre-existing dementia or aphasia with severe language comprehension deficits
  • Alcohol or substance abuse or dependence within the last 12 months
  • Recurrent unipolar or bipolar disorder prior to the stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242-1000, United States

Location

Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

Related Publications (3)

  • Mikami K, Jorge RE, Moser DJ, Arndt S, Jang M, Solodkin A, Small SL, Fonzetti P, Hegel MT, Robinson RG. Increased frequency of first-episode poststroke depression after discontinuation of escitalopram. Stroke. 2011 Nov;42(11):3281-3. doi: 10.1161/STROKEAHA.111.626507. Epub 2011 Aug 25.

    PMID: 21868736DERIVED

  • Jorge RE, Acion L, Moser D, Adams HP Jr, Robinson RG. Escitalopram and enhancement of cognitive recovery following stroke. Arch Gen Psychiatry. 2010 Feb;67(2):187-96. doi: 10.1001/archgenpsychiatry.2009.185.

    PMID: 20124118DERIVED

  • Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400. doi: 10.1001/jama.299.20.2391.

    PMID: 18505948DERIVED

MeSH Terms

Conditions

DepressionStroke

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 29, 2003

First Posted

October 30, 2003

Study Start

September 1, 2002

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

September 5, 2017

Record last verified: 2017-08

Locations

US(3)