Trial Outcomes & Findings for Identifying and Treating Depression in Hemodialysis Patients (NCT NCT03390933)
NCT ID: NCT03390933
Last Updated: 2024-10-17
Results Overview
remission of depression, defined as a week 12 Patient Health Questionnaire 9 (PHQ-9) total score of \<5. The survey consists of 9 questions to gauge depression/depressive symptoms. Each question asks - Over the last 2 weeks, how often have you been bothered by any of the following problems: Each questions 0-3 scale (0=not at all 1= several days 2= more than half the days 3=nearly every day ). Range =0min to 27max. A TOTAL SCORE OF ≥10 IS AN ESTABLISHED THRESHOLD FOR CLINICALLY RELEVANT DEPRESSIVE SYMPTOMS. Less than 5 is total remission of depressive symptoms.
COMPLETED
PHASE4
16 participants
3 years
2024-10-17
Participant Flow
Screened Via Chart Abstraction 1588 In person Screening Conducted 1248 Evaluated for Major Depression Disorder 110 Untreated for Major Depressive Disorder 27 Consented/enrolled into trial 16
Participant milestones
| Measure |
Fluoxetine Group
Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.
Fluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.
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|---|---|
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Overall Study
STARTED
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16
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Overall Study
COMPLETED
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15
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Overall Study
NOT COMPLETED
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1
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Identifying and Treating Depression in Hemodialysis Patients
Baseline characteristics by cohort
| Measure |
Fluoxetine Group
n=16 Participants
Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.
Fluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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14 Participants
n=5 Participants
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Age, Categorical
>=65 years
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2 Participants
n=5 Participants
|
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Sex: Female, Male
Female
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13 Participants
n=5 Participants
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Sex: Female, Male
Male
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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1 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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15 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Asian
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Black or African American
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13 Participants
n=5 Participants
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Race (NIH/OMB)
White
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3 Participants
n=5 Participants
|
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Race (NIH/OMB)
More than one race
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0 Participants
n=5 Participants
|
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=5 Participants
|
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Region of Enrollment
United States
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16 participants
n=5 Participants
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PATIENT HEALTH QUESTIONNAIRE 9
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11.3 units on a scale
STANDARD_DEVIATION 4.9 • n=5 Participants
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PRIMARY outcome
Timeframe: 3 yearsPopulation: Enrolled 16 * 13 Female * 13 African American * 1 Hispanic
remission of depression, defined as a week 12 Patient Health Questionnaire 9 (PHQ-9) total score of \<5. The survey consists of 9 questions to gauge depression/depressive symptoms. Each question asks - Over the last 2 weeks, how often have you been bothered by any of the following problems: Each questions 0-3 scale (0=not at all 1= several days 2= more than half the days 3=nearly every day ). Range =0min to 27max. A TOTAL SCORE OF ≥10 IS AN ESTABLISHED THRESHOLD FOR CLINICALLY RELEVANT DEPRESSIVE SYMPTOMS. Less than 5 is total remission of depressive symptoms.
Outcome measures
| Measure |
Fluoxetine Group
n=16 Participants
Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.
Fluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.
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|---|---|
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To Determine the Impact of Directly Observed Weekly Fluoxetine Treatment on Remission of Depression Among Hemodialysis Patients.
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6.6 units on a scale
Standard Deviation 2
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Adverse Events
Fluoxetine Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Fluoxetine Group
n=16 participants at risk
Approximately 96 patients will be enrolled into the intervention (Phase II) over the duration of the entire study.
Fluoxetine: Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.
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|---|---|
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Gastrointestinal disorders
Nausea
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6.2%
1/16 • Number of events 1 • All side effects ASSESSED EVERY OTHER WEEK OVER A TWELVE WEEK PERIOD while patients were actively taking fluoxetine.
Participants will be seen on a weekly basis. Every other week, the study nurse practitioner will review any side effects the participant is having and record any adverse events. These check ins will be recorded on the study Progress Note and also the Fluoxetine Follow Up Checklist form. These notes will be reviewed on a weekly basis by the study team as a whole.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place