Efficacy of Fluoxetine - a Trial in Stroke "EFFECTS"

Recruiting

Phase 3 Results N/A

Trial Description

The purpose of this study is to investigate whether routine administration of fluoxetine 20mg once daily in the 6 months initiated during the acute stroke improves the patient's functional outcome.
EFFECTS is an investigator lead Sweden-based, multicenter, parallel group, double blind placebo controlled trial with broad entry criteria and follow up at 6 and 12 months.
The anticipated numbers of participants is 1,500 in Sweden. As of 31 August 2017, EFFECTS has recruited 810 participants at 35 centers. Last patient in is anticipated July 2019, with the last follow-up one year later.

Detailed Description

Stroke is a serious, life-threatening medical condition that happens when the blood supply to a part of the brain is cut off, usually due to a blood clot (ischemic) or hemorrhage. Symptoms vary according to how much of the brain is affected and where in the brain the stroke occurs but includes paralysis, muscle weakness and speech problems.
A stroke can also have an impact on the sufferers emotions and can lead to anxiety, depression and personality changes. Fluoxetine (otherwise known as Prozac) has been used for many years to treat depression. However, there is evidence to suggest that it may also have other effects of the brain and enhance brain plasticity (the reorganisation of neural pathways in the brain) in a number of different ways.
One small study, for example, has shown that, if taken soon after a stroke, fluoxetine might improve the recovery of arm strength and lead to greater restoration of movement of the limbs.
Adult participants (at least 18 years old) who have had a stroke (either ischemic or hemorrhagic) within the last 2-15 days and still have some residual problems caused by the stroke e.g. weakness, or problems with their speech (speech impairment).
Participants are randomly allocated into one of two groups. Those in group 1 are given fluoxetine capsules for 6 months. Those in group 2 are given a placebo capsules for 6 months.
The participants are contacted after one week of starting their treatment, and then again after one month, to check on their well-being and that they are still taking their allocated caplets. Each participant is asked about any side effects and how much training they have had with e.g. a physiotherapist, occupational- or speech-therapist.
The research team contacts each participant at 3 months to check whether they are still taking the capsules, ask about bad side effects, and about how they are feeling (mood). If all is well, the participant is given enough medication to cover the rest of the study period.
The participant is asked to stop the study medication after 6 months and repeat assessments that they did before they started the study at the local hospital. They are also asked to fill in questionnaires together with their next of kin or carer. These questionnaires are sent to the trial main centre. If needed, they can also be filled in with the help of a trial nurse over the telephone.
The participants are contacted again one month after they have stopped the medication to see how they have progressed.
At 12 months after recruitment, participants are asked to complete the same questionnaires again about how well they have recovered from their stroke and what problems they now have after the stroke e.g. weakness in limbs, memory problems, problems with speech, low mood. These questionnaires can again be completed on paper or by telephone. The researchers then collect data on long-term recovery through national statistics.

Conditions

Interventions

  • Fluoxetine (Prozac®)Drug
    Other Names: Patients receiving fluoxetine
    Intervention Desc: Fluoxetine 20mg once daily for 6 months.
    ARM 1: Kind: Experimental
    Label: Fluoxetine
    Description: One capsule Fluoxetine 20mg once daily for 6 months.
  • Placebo Drug
    Intervention Desc: Matching placebo.
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: One matching capsule placebo once daily for 6 months.

Trial Design

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

Outcomes

Type Measure Time Frame Safety Issue
Primary Functional status, measured with the modified Rankin scale. 6 months No
Secondary Survival This will be determined by following patients up for 12 months. Yes
Secondary Health status measured with the Stroke Impact Scale At 6 and 12 months No
Secondary Arm, hand, leg and foot strength assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Hand function assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Mobility assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Communication and understanding assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Memory and thinking assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Mood and emotions assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Daily activities assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Participation in work, leisure and social activities assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Overall rating of recovery assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Adverse events/outcomes At 6 and 12 months Yes
Secondary Depression using the Montgomery-Åsberg Depression Rating Scale (MADRS) At 6 and 12 months No
Secondary Number of participants with a recurrent stroke including ischaemic and hemorrhagic strokes At 6 and 12 months Yes
Secondary Number of participants with an acute coronary syndromes At 6 and 12 months Yes
Secondary Number of participants with an Epileptic seizures At 6 and 12 months Yes
Secondary Number of participants with an episodes of Hyponatraemia At 6 and 12 months Yes
Secondary Number of participants with an upper gastrointestinal bleeding At 6 and 12 months Yes
Secondary Number of participants with other major bleeds At 6 and 12 months Yes
Secondary Number of participants with poorly controlled diabetes At 6 and 12 months Yes
Secondary Number of participants with falls resulting in injury At 6 and 12 months Yes
Secondary Number of participants with new fractures At 6 and 12 months Yes
Secondary Fatigue measured with the vitality subscale of the Health Questionnaire At 6 and 12 months No
Secondary Cognition assessed with the Stroke Impact Scale At 6 and 12 months No
Secondary Health-related quality of life measured with the five-level Euroqol 5D (EQ5D-5 L) At 6 and 12 months No
Secondary Cost-effectiveness and cost-utility assessed by measuring costs, survival and health related quality of life (EQ5D) At 6 and 12 months No

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