Trial Outcomes & Findings for Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania (NCT NCT03728153)

NCT ID: NCT03728153

Last Updated: 2022-05-25

Results Overview

Serum Sodium Concentration was measured in mmol/L. Hyponatremia was considered as \<125 mmol/L.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 34 participants
• Primary outcome timeframe: 90 days following acute, ischemic stroke
• Results posted on: 2022-05-25

Participant Flow

Participant milestones

Measure	20mg Dose Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania

Baseline characteristics by cohort

Measure	20mg Dose n=34 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Age, Continuous	52 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	34 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Tanzania	34 participants n=5 Participants

PRIMARY outcome

Timeframe: 90 days following acute, ischemic stroke

Serum Sodium Concentration was measured in mmol/L. Hyponatremia was considered as <125 mmol/L.

Outcome measures

Measure	20mg Dose n=32 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Serum Sodium Concentration	138.7 mmol/L Standard Deviation 2.9

PRIMARY outcome

Timeframe: 90 days

Hepatic impairment was measured by elevation of hepatic enzyme (serum alanine aminotransferase; ALT) of >120 U/L

Outcome measures

Measure	20mg Dose n=32 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Serum Alanine Aminotransferase (ALT)	28 U/L Interval 10.0 to 134.0

SECONDARY outcome

Timeframe: 90 days following acute, ischemic stroke

The Fugl Meyer motor scale is used to assess post-stroke motor recovery in stroke patients. It is scored on a scale from 0 to 100, with lower scores indicating greater disability. It evaluates both lower and upper extremities for motor performance: 66 points are allocated to the upper extremities, 34 to the lower extremities. The two extremities are summed to achieve the total score.

Outcome measures

Measure	20mg Dose n=32 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Fugl-Meyer Motor Scale Score for Assessment of Motor Function After Stroke	62.7 score on a scale Standard Deviation 28.1

SECONDARY outcome

Timeframe: 90 days following acute, ischemic stroke

10-item questionnaire used to evaluate the severity of a patient's depressive symptoms. Each item is scored on a scale from 0 to 6, the scores are summed, and the total score (0 to 60 points) is reported. The greater the score, the more severe the degree of depression.

Outcome measures

Measure	20mg Dose n=32 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Montgomery-Asberg Depression Rating Scale	5.6 units on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: 90 days following acute, ischemic stroke

Validated instrument for measuring the degree of disability in stroke patients. The modified Rankin Scale is based on a physicians subjective evaluation. The scale ranges from 0, indicating perfect health, to 6, indicating that the patient is dead.

Outcome measures

Measure	20mg Dose n=32 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Modified Rankin Scale	2 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: 90 days following acute ischemic stroke

The PHQ-9 is a validated 9-point questionnaire for measuring depression symptom severity. Each question is scored from 0-3. Answers are summed and the total score (0 to 27) is reported. The greater the score, the greater the severity of depression.

Outcome measures

Measure	20mg Dose n=32 Participants Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
The Patient Health Questionnaire-9 (PHQ-9) Scale for Measuring Depression	4.6 units on a scale Standard Deviation 4.1

Adverse Events

20mg Dose

Serious events: 8 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Measure	20mg Dose n=34 participants at risk Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
General disorders Intermittent emesis and decreased appetite, hyponatremia serum Na+=120 mmol/L	2.9% 1/34 • Number of events 1 • 90 days
General disorders Abnormal lab results	2.9% 1/34 • Number of events 1 • 90 days
Nervous system disorders Confusion, dizziness, weakness, transient aphasia	2.9% 1/34 • Number of events 1 • 90 days
Nervous system disorders Right supranuclear facial palsy, left hemiparesis	2.9% 1/34 • Number of events 1 • 90 days
Cardiac disorders Cardiac arrest	2.9% 1/34 • Number of events 1 • 90 days
General disorders Pneumonia, severe malaria, anemia, worm infestation, and urinary tract infection	2.9% 1/34 • Number of events 1 • 90 days
General disorders Upper gastrointestinal bleeding, cardiac arrest	2.9% 1/34 • Number of events 1 • 90 days

Other adverse events

Measure	20mg Dose n=34 participants at risk Fluoxetine 20 MG Oral Tablet Fluoxetine 20 MG Oral Tablet: Once-daily dosing for 90 days
Reproductive system and breast disorders Urinary tract infection	2.9% 1/34 • Number of events 1 • 90 days
Skin and subcutaneous tissue disorders Swelling of L arm and L foot	2.9% 1/34 • Number of events 1 • 90 days

Additional Information

Farrah Mateen

Massachusetts General Hospital

Phone: 16177248653

Email: fmateen@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place