Major Depressive Disorder, Pain, Soft Tissue Discomfort Syndrome
Conditions
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.
Interventions
DRUGDuloxetine
30-60 mg daily for 8 weeks
Sponsors
Eli Lilly and Company
University of Pennsylvania
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-hour Activity Level | Baseline and Week One of Treatment |
Secondary
| Measure | Time frame |
|---|---|
| Functional Symptom Questionnaire | Baseline; Week 6 and Week 8 of Treatment |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine Duloxetine: 30-60 mg daily for 8 weeks | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Customized All Participants | — participants |
| Region of Enrollment United States | — participants |
| Sex/Gender, Customized All Participants | — participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
24-hour Activity Level
Time frame: Baseline and Week One of Treatment
Population: 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.
Secondary
Functional Symptom Questionnaire
Time frame: Baseline; Week 6 and Week 8 of Treatment
Population: 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.