Trial Outcomes & Findings for Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults (NCT NCT00696293)

Results Overview

The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome Larger reduction between MADRS from baseline to 12 weeks would represent better outcome

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

baseline and 12 weeks

Results posted on

2017-02-01

Participant Flow

Participant milestones

Participant milestones
Measure	Duloxetine Plus Clinical Management Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management
Overall Study STARTED	30
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Duloxetine Treatment of Major Depression and Chronic Low Back Pain For Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Duloxetine Plus Clinical Management n=30 Participants Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management
Age, Continuous	71.4 years STANDARD_DEVIATION 7.61 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline and 12 weeks

Population: description of median change

The MADRS is a rating of depression severity with theoretical scale range 0-60, with lower values representing better outcome Larger reduction between MADRS from baseline to 12 weeks would represent better outcome

Outcome measures

Outcome measures
Measure	Duloxetine Plus Clinical Management n=28 Participants Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management
Change in Montgomery Asberg Depression Rating Scale(MADRS) Score From Baseline and 12 Weeks	-11.7 units on a scale Standard Deviation 6.5

PRIMARY outcome

Timeframe: Baseline and 12 weeks

The McGill Pain Questionaire, short form consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe. The McGill Pain Questionaire score ranged from 0 (none) to 45 (severe). A larger reduction of the score from baseline to 12 weeks would represent a better outcome

Outcome measures

Outcome measures
Measure	Duloxetine Plus Clinical Management n=28 Participants Duloxetine + clinical management Duloxetine: Duloxetine up to 120 mg/day + Clinical Management
Change in McGill Pain Questionaire, Short Form, Score From Baseline and 12 Weeks	-6.0 units on a scale Standard Deviation 1.9

Adverse Events

Duloxetine Plus Clinical Management

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

Jordan F. Karp, MD

University of Pittsburgh

Phone: 412-246-6048

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place