Preventing Post-Stroke Depression

Completed

Phase N/A Results

Trial Description

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

Detailed Description

The development of depression after a stroke is a serious condition that can have negative effects on thought, emotions, and overall daily functioning, particularly in the first year following the stroke. Evidence suggests that antidepressants may be used to prevent post-stroke depression. This study will treat nondepressed stroke patients with antidepressants or problem solving therapy (PST) to determine the most effective treatments for preventing depression.
Participants in this study will be randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.

Conditions

Interventions

  • Escitalopram (Lexapro)Drug
    Other Names: Lexapro
    Intervention Desc: Participants will receive escitalopram, a selective serotonin reuptake inhibitor.
    ARM 1: Kind: Experimental
    Label: 2. Escitalopram
    Description: Participants will receive escitalopram.
  • Problem Solving Therapy Behavioral
    Intervention Desc: Problem solving therapy aims to make patients aware of symptoms of problems and link those with behaviors associated with solving them.
    ARM 1: Kind: Experimental
    Label: 1 Problem Solving Therapy
    Description: Participants will receive problem solving therapy.
  • Placebo Drug
    Intervention Desc: Participants will receive a placebo pill.
    ARM 1: Kind: Experimental
    Label: 3 Placebo
    Description: Participants will receive placebo.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Participants in this study are randomly assigned to receive PST, escitalopram, or placebo (an inactive pill) for 12 months. Participants who display depressive symptoms for 2 weeks or more will be removed from the study. After 12 months, treatment will be discontinued and participants will be monitored for an additional 6 months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Development of major or minor poststroke depression based on symptoms elicited by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) (DSM-IV) and the diagnostic criteria from DSM-IV for depression due to stroke with major depressive-like episode or minor depression (ie, research criteria).
Primary Incidence of depressive disorders in the study population Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 No
Secondary Functional Independence Measure Measured at baseline, at Week 6, and at Months 3, 6, 9, 12, and 18 No
Secondary Stroke Impact Scale Measured at baseline, Week 6, and Months 3, 6, 9, 12, and 18 No
Secondary Neurocognitive tests of executive functions and speed of information processing Measured at baseline and after 12 months No

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