Major Depressive Disorder
Conditions
Keywords
Depression, Pharmacotherapy, Duloxetine
Brief summary
The purpose of this study is to explore benefits of duloxetine in enhancing psychological resilience and to understand the relevance of inhibiting of both serotonin (5HT) and norepinephrine (NE)to therapeutic responses.
Detailed description
This is an investigator-initiated, single-site study consisting of 8 weeks of open-label, fixed-dose treatment with duloxetine (30mg-60mg/day) in patients with Major Depressive Disorder (MDD).
Interventions
DRUGDuloxetine
Open label treatment with Duloxetine for 8 wks. Dose 30-60 mg.
Sponsors
Duke University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* ages 18-65 * primary diagnosis of MDD based on Diagnostic Standard Manual(DSM-IV) criteria and assessed by the MINI International Neuropsychiatric Interview * Montgomery-Asberg Depression Rating Scale (MADRS)score of at least 20 on baseline * Minimum Clinical Global Impressions of Severity (CGS) severity score of 4 * Ability to provide written consent form * A negative serum pregnancy test for women of childbearing potential
Exclusion criteria
* Current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, mental retardation or other pervasive developmental disorder or cognitive disorder due to a general medical condition * History of substance abuse or dependence within the last 6 months * Suicide risk or serious suicide attempt within the last year * Clinically significant medical condition or laboratory abnormality * Women of childbearing potential who are unwilling to practice an acceptable method of contraception * Subjects needing concurrent use of psychotropic medications * History of sensitivity to duloxetine * History of failure to respond to an adequate trial of duloxetine (at least 60mg/day for 4 weeks) * Subjects taking monoamine oxidase inhibitors (MAOIs) * Subjects with uncontrolled narrow-angle glaucoma
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Open Label Treatment Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg. | 18 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Sedation | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Open Label Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Age Continuous | 43.44 years STANDARD_DEVIATION 9.21 |
| Region of Enrollment United States | 18 participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 18 |
| serious Total, serious adverse events | 0 / 18 |
Outcome results
Primary
Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 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.
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Change in Connor Davidson Resilience Scale (CD-RISC) From Baseline to 8 Weeks | 52.62 units on a scale | Standard Deviation 16.61 |
Comparison: Wilcoxon Signed Rank test on the difference between the baseline and endpoint score on the CD-RISC.p-value: 0.00365Wilcoxon (Mann-Whitney)