Trial Outcomes & Findings for Pilot Study of Duloxetine in Psychological Resilience (NCT NCT00331799)

Results Overview

CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

18 participants

Primary outcome timeframe

baseline and 8 weeks

Results posted on

2013-08-02

Participant Flow

Participant milestones

Participant milestones
Measure	Open Label Treatment With Duloxetine Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
Overall Study STARTED	18
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Open Label Treatment With Duloxetine Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
Overall Study Withdrawal by Subject	2
Overall Study Sedation	1

Baseline Characteristics

Pilot Study of Duloxetine in Psychological Resilience

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Open Label Treatment n=18 Participants Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age Continuous	43.44 years STANDARD_DEVIATION 9.21 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 8 weeks

CD-RISC has been psychometrically validated, studied in the general population, as well as in clinical samples. Changes in CD-RISC score have been found to be sensitive to the effect of treatment, and impaired resilience has been demonstrated in subjects with depression relative to normal controls using this scale (Connor and Davidson, 2003). The total score ranges from 0-100, with higher scores indicating greater resilience.

Outcome measures

Outcome measures
Measure	Duloxetine n=18 Participants Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks	52.62 units on a scale Standard Deviation 16.61

Adverse Events

Open Label Treatment

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

Wei Zhang MD

Duke University Medical Center Dept of Psychiatry

Phone: 919 684 5645

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place