Trial Outcomes & Findings for Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma (NCT NCT04850222)
NCT ID: NCT04850222
Last Updated: 2026-05-14
Results Overview
Scores are typically reported as T-scores, which generally range from about 20-80 (population mean = 50, standard deviation = 10). Higher scores indicate worse outcomes, meaning greater perceived social isolation, a higher PROMIS Social Isolation score reflects feeling more isolated, excluded, or disconnected from others, while lower scores indicate better social connectedness and less isolation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
6 weeks, 3 months,6 months, 1 year
Results posted on
2026-05-14
Participant Flow
Participant milestones
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
33
|
|
Overall Study
COMPLETED
|
13
|
17
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=22 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=33 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=22 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=55 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=22 Participants
|
29 Participants
n=33 Participants
|
49 Participants
n=55 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=22 Participants
|
4 Participants
n=33 Participants
|
6 Participants
n=55 Participants
|
|
Age, Continuous
|
40.3 Years
STANDARD_DEVIATION 17.7 • n=22 Participants
|
43.5 Years
STANDARD_DEVIATION 15.8 • n=33 Participants
|
41.9 Years
STANDARD_DEVIATION 16.75 • n=55 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=22 Participants
|
14 Participants
n=33 Participants
|
26 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=22 Participants
|
19 Participants
n=33 Participants
|
29 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
22 Participants
n=22 Participants
|
33 Participants
n=33 Participants
|
55 Participants
n=55 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks,3 months, 6 months, 1 yearPopulation: subjects lost to follow up
Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of depressive symptoms.
Outcome measures
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=22 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=33 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
BDI-II - Beck Depression Inventory-II
Baseline
|
11.4 units on a scale
Standard Deviation 7.4
|
12.8 units on a scale
Standard Deviation 15.3
|
|
BDI-II - Beck Depression Inventory-II
2 weeks
|
9.6 units on a scale
Standard Deviation 8.9
|
11.5 units on a scale
Standard Deviation 11.6
|
|
BDI-II - Beck Depression Inventory-II
6 weeks
|
8.1 units on a scale
Standard Deviation 6.4
|
12.2 units on a scale
Standard Deviation 12.9
|
|
BDI-II - Beck Depression Inventory-II
3 months
|
11.1 units on a scale
Standard Deviation 12.6
|
7.5 units on a scale
Standard Deviation 8.9
|
|
BDI-II - Beck Depression Inventory-II
6 months
|
7.2 units on a scale
Standard Deviation 11.2
|
11.9 units on a scale
Standard Deviation 15.5
|
|
BDI-II - Beck Depression Inventory-II
1 year
|
7.9 units on a scale
Standard Deviation 11
|
9.1 units on a scale
Standard Deviation 11
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 yearPopulation: subjects lost to follow up
Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of anxiety symptoms.
Outcome measures
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=22 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=33 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
BAI - Beck Anxiety Inventory
1 year
|
9.7 units on a scale
Standard Deviation 12.9
|
8.9 units on a scale
Standard Deviation 8.1
|
|
BAI - Beck Anxiety Inventory
6 months
|
7.9 units on a scale
Standard Deviation 12.3
|
12.4 units on a scale
Standard Deviation 12.6
|
|
BAI - Beck Anxiety Inventory
Baseline
|
12.7 units on a scale
Standard Deviation 12.2
|
11.5 units on a scale
Standard Deviation 9.9
|
|
BAI - Beck Anxiety Inventory
2 weeks
|
9.9 units on a scale
Standard Deviation 10.3
|
12.5 units on a scale
Standard Deviation 10
|
|
BAI - Beck Anxiety Inventory
6 weeks
|
10.5 units on a scale
Standard Deviation 10.5
|
10.8 units on a scale
Standard Deviation 11.2
|
|
BAI - Beck Anxiety Inventory
3 months
|
10.8 units on a scale
Standard Deviation 12.6
|
9 units on a scale
Standard Deviation 10.2
|
PRIMARY outcome
Timeframe: 2 weeks, 6 weeks, 3 monthsPopulation: subjects lost to follow up
Score range 0-21. Higher scores indicate worse outcomes, representing poorer sleep quality.
Outcome measures
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=20 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=31 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
PSQI - Pittsburgh Sleep Quality Index
6 weeks
|
7.1 units on a scale
Standard Deviation 4.8
|
7.3 units on a scale
Standard Deviation 4.4
|
|
PSQI - Pittsburgh Sleep Quality Index
3 months
|
7.1 units on a scale
Standard Deviation 4.8
|
6.6 units on a scale
Standard Deviation 4.7
|
|
PSQI - Pittsburgh Sleep Quality Index
2 weeks
|
7 units on a scale
Standard Deviation 4.1
|
9.4 units on a scale
Standard Deviation 5.3
|
PRIMARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 6 months, 1 yearPopulation: subjects lost to follow up
Score range 0-80. Higher scores indicate worse outcomes, representing greater PTSD symptom severity.
Outcome measures
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=22 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=33 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5
Baseline
|
21.9 units on a scale
Standard Deviation 17.2
|
15.1 units on a scale
Standard Deviation 16
|
|
PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5
2 weeks
|
15.9 units on a scale
Standard Deviation 16.4
|
19.3 units on a scale
Standard Deviation 18.2
|
|
PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5
6 weeks
|
14.8 units on a scale
Standard Deviation 15.1
|
17.3 units on a scale
Standard Deviation 19.5
|
|
PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5
6 months
|
11.1 units on a scale
Standard Deviation 18.5
|
15.5 units on a scale
Standard Deviation 18.7
|
|
PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5
1 year
|
10.5 units on a scale
Standard Deviation 15.1
|
19.9 units on a scale
Standard Deviation 21.1
|
PRIMARY outcome
Timeframe: 6 weeks, 3 months,6 months, 1 yearPopulation: subjects lost to follow up
Scores are typically reported as T-scores, which generally range from about 20-80 (population mean = 50, standard deviation = 10). Higher scores indicate worse outcomes, meaning greater perceived social isolation, a higher PROMIS Social Isolation score reflects feeling more isolated, excluded, or disconnected from others, while lower scores indicate better social connectedness and less isolation.
Outcome measures
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=20 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=28 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System
6 weeks
|
43.7 units on a scale
Standard Deviation 9.4
|
47.7 units on a scale
Standard Deviation 8.4
|
|
PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System
3 months
|
45.9 units on a scale
Standard Deviation 9.5
|
49 units on a scale
Standard Deviation 9.6
|
|
PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System
6 months
|
50.8 units on a scale
Standard Deviation 8
|
47.8 units on a scale
Standard Deviation 8.4
|
|
PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System
1 year
|
54.3 units on a scale
Standard Deviation 10.1
|
48.9 units on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 yearPopulation: subjects lost to follow up
Score range 0-10. Higher scores indicate worse outcomes, representing greater pain intensity and interference with enjoyment of life and general activity.
Outcome measures
| Measure |
Subjects Randomized to Get Fluoxetine Therapy
n=22 Participants
Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Fluoxetine: Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
Subjects Randomized to Get Calcium Supplmentation
n=33 Participants
Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
Calcium: Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
|
|---|---|---|
|
PEG - Pain, Enjoyment of Life, and General Activity Scale
6 months
|
2.7 units on a scale
Standard Deviation 2.3
|
4 units on a scale
Standard Deviation 2.8
|
|
PEG - Pain, Enjoyment of Life, and General Activity Scale
1 year
|
3 units on a scale
Standard Deviation 2.8
|
4.9 units on a scale
Standard Deviation 3.1
|
|
PEG - Pain, Enjoyment of Life, and General Activity Scale
Baseline
|
5.7 units on a scale
Standard Deviation 3.6
|
4.9 units on a scale
Standard Deviation 3.7
|
|
PEG - Pain, Enjoyment of Life, and General Activity Scale
2 weeks
|
5.3 units on a scale
Standard Deviation 3
|
6.1 units on a scale
Standard Deviation 2.8
|
|
PEG - Pain, Enjoyment of Life, and General Activity Scale
6 weeks
|
3.9 units on a scale
Standard Deviation 3.1
|
4.2 units on a scale
Standard Deviation 2.9
|
|
PEG - Pain, Enjoyment of Life, and General Activity Scale
3 months
|
4.3 units on a scale
Standard Deviation 2.5
|
4.6 units on a scale
Standard Deviation 3.1
|
Adverse Events
Subjects Randomized to Get Fluoxetine Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects Randomized to Get Calcium Supplmentation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place