Treatment for Post-Stroke Depression

Completed

Phase 4 Results

Trial Description

The purpose of this study is to evaluate a program of education, medicine, and monitoring for the treatment of depression after a stroke.

Detailed Description

This trial will compare outcomes in depressed patients receiving the Activate-Initiate-Monitor (AIM) intervention vs. those receiving usual care, and will also compare outcomes in depressed and non-depressed stroke survivors. Patients are screened for depression 1 to 2 months post-stroke. Patients with depression are then randomized to the AIM intervention or control group. Patients without depression are also enrolled at the same time and are matched by hospital site to the depressed patients.
The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance. Control patients are evaluated and treated with usual care by their physicians. Patients without depression do not receive the intervention but complete the same assessments on the same schedule as the patients with depression.

Conditions

Interventions

  • Antidepressant agents Behavioral
    Intervention Desc: Category includes all drugs used for treatment of depression.
  • Activate-Initiate-Monitor (AIM) intervention Other
    Intervention Desc: The AIM intervention is a 3-part program consisting of activating or educating the patient and his/her family about post-stroke depression, instituting treatment for depression, and monitoring antidepressant treatments for side effects, efficacy, and compliance.
  • Case management Behavioral
    ARM 1: Kind: Experimental
    Label: Nurse Case management

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment

Patient Involvement

Eligible patients are screened for depression 1-2 months post-stroke. Depressed patients are case-matched with non-depressed patients, and subsequently randomized into AIM and control treatment groups. The AIM group will receive education concerning post-stroke depression, antidepressant drugs (one of two SSRI's, or a serotonin-norepinephrine reuptake inhibitor), and monitoring for side effects, drug efficacy, and compliance. The control group will receive standard treatment for depression. All patients will be evaluated for depression, quality of life, and stroke outcome, on the same schedule. Family members and caregivers will also be screened for depression.

Outcomes

Type Measure Time Frame Safety Issue
Primary 12-week and 9-month post-stroke depression (measured with the Patient Health Questionnaire (PHQ), Hamilton Depression Inventory (HAMD), and a DSM-IV-based structured clinical interview), quality of life (assessed by the SS-QOL), and stroke outcomes.
Primary Twelve Week Depression Outcomes Twelve week No

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