Functional Change and Efficacy of Duloxetine in Patients With Co-Morbid Depression & Soft Tissue Discomfort Syndrome

• Sponsor: University of Pennsylvania (Other)
• Overall Status: Completed
• CT.gov ID: NCT01035073
• Collaborator: Eli Lilly and Company (Industry)
• Enrollment: 22
• Location: 1
• Arm: 1
• Duration (Months): 37
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The objective of this study is to determine the time course of duloxetine efficacy on the symptoms of Major Depressive Disorder (MDD)and on the symptoms of Soft Tissue Discomfort Syndrome(STDS) via use of 24-hour Actigraph™ measures.

We hypothesize that there will be a reduction in both MDD and STDS symptoms in MDD patients with co-morbid STDS symptoms. We further hypothesize that there will be a rapid improvement in functional outcome ratings and 24-hour activity in MDD patients with co-morbid STDS symptoms which may occur even before the antidepressant effect is observed.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder; Soft Tissue Discomfort Syndrome; Pain	Drug: Duloxetine	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Functional Change and Efficacy of Duloxetine in Patients With Major Depression and Co-Morbid Soft Tissue Discomfort Symptoms
• Study Start Date: Apr 1, 2006
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: May 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Duloxetine	Drug: Duloxetine; 30-60 mg daily for 8 weeks; Other Names: Cymbalta

Outcome Measures

Primary Outcome Measures

1. 24-hour Activity Level [Baseline and Week One of Treatment]

Secondary Outcome Measures

1. Functional Symptom Questionnaire [Baseline; Week 6 and Week 8 of Treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 17 years old

• All races and ethnicity

• DSM IV-TR Axis I diagnosis of MDD

• Co-morbid STDS

• Baseline 17-item Hamilton Depression Rating > 13

Exclusion Criteria:

• Primary Axis I disorder other than MDD

• History of mania or psychosis

• Actively suicidal

• Required hospitalization

• A alcohol or substance abuse or dependence within the preceding 3 months

• Pregnant or nursing

• Unstable medical condition (other than STDS)

• Narrow-angle glaucoma

• Sensitivity to duloxetine, concurrent antidepressant, tranquilizer, or mood stabilizer use

• Hepatic or renal insufficiency

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Depression Research Unit, University of Pennsylvania School of Medicine	Philadelphia	Pennsylvania	United States	19104-3309

Sponsors and Collaborators

• University of Pennsylvania
• Eli Lilly and Company

Investigators

• Principal Investigator: Jay D Amsterdam, MD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01035073
• Other Study ID Numbers: F1J-US-X018
• First Posted: Dec 18, 2009
• Last Update Posted: Apr 16, 2020
• Last Verified: Apr 1, 2020

• Additional relevant MeSH terms: Syndrome; Depressive Disorder; Depressive Disorder, Major; Duloxetine Hydrochloride

Study Results

Participant Flow

Pre-assignment Detail	The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.

Arm/Group Title	Duloxetine
Arm/Group Description	Duloxetine: 30-60 mg daily for 8 weeks
Period Title: Overall Study
STARTED	0
COMPLETED	0
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Duloxetine
Arm/Group Description	Duloxetine: 30-60 mg daily for 8 weeks
Overall Participants	0
Age, Customized (participants) []
Sex/Gender, Customized (participants) []
Race and Ethnicity Not Collected () []
Region of Enrollment (participants) []

Outcome Measures

1. Primary Outcome

Title	24-hour Activity Level
Time Frame	Baseline and Week One of Treatment

Outcome Measure Data

Analysis Population Description

The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.

Arm/Group Title	Duloxetine
Arm/Group Description	Duloxetine: 30-60 mg daily for 8 weeks
Measure Participants	0

2. Secondary Outcome

Title	Functional Symptom Questionnaire
Time Frame	Baseline; Week 6 and Week 8 of Treatment

Outcome Measure Data

Analysis Population Description

The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.

Arm/Group Title	Duloxetine
Arm/Group Description	Duloxetine: 30-60 mg daily for 8 weeks
Measure Participants	0

Adverse Events

Time Frame	3 Years
Adverse Event Reporting Description	The investigator has succumb to serious health issues which prevents him from physically inputting data in the system. The study team is no longer at the university and despite all efforts to contact them in order to enter data on the investigator's behalf, data are not available.
Arm/Group Title	Duloxetine
Arm/Group Description	Duloxetine: 30-60 mg daily for 8 weeks
All Cause Mortality
	Duloxetine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Serious Adverse Events
	Duloxetine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Duloxetine
	Affected / at Risk (%)	# Events
Total	0/0 (NaN)

Limitations/Caveats

Data is unavailable for the following reasons: investigator has succumb to serious health conditions preventing him from entering data, and study team members no longer work for the university and cannot be reached to input data despite efforts.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.