Depressive Disorder, Major
Conditions
Brief summary
This study was designed to determine if the novel combination of the SSRI, sertraline, and the NRI reboxetine will increase antidepressant efficacy without sacrificing the favorable safety profile of SSRIs.
Interventions
DRUGsertraline/[S,S]-reboxetine
Tablets, 50mg sertraline/2mg \[S,S\]-reboxetine for 3 days orally, followed by 100mg sertraline/4mg \[S,S\]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/4mg \[S,S\]-reboxetine for 5 and one half weeks.
DRUGsertraline
Tablets, 50 mg/day orally for 3 days, followed by 100 mg/day orally for 4 and one half weeks, followed by 150 mg/day orally for 3 weeks.
DRUGPlacebo
Tablets, orally once per day for 8 weeks
DRUG[S,S]-reboxetine monotherapy
Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must fulfill the criteria for MDD without psychotic features as defined by DSMIV, based on clinical assessment and confirmed by Structural Clinical Interview for DSM-IV Axis I Disorder-Clinical Version (SCID-I) plus the MDD Specifiers included in the Research Version of SCID-I. * HAM-D (17-item) ≥ 22 at Screening (Visit 1) and \> 20 at Baseline (Visit 2). * Minimum CGI-S ≥ 4 at Screening (Visit 1) and at Baseline (Visit 2).
Exclusion criteria
* Known failure to satisfactory respond after adequate dose and duration (12 weeks) of treatment with clomipramine and one SSRI, or with two or more SSRIs. * Subjects with \> 20% HAM-D (17-item) improvement (decrease) from Screening (Visit 1) at Baseline (Visit 2). * Subjects with uncorrected hypothyroidism or hyperthyroidism.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from Baseline up to Week 8 (Visit 9) in the Montgomery-Asberg Depression Rating Scale (MADRS) total score as measured by a mixed concentration, suicidal ideation and restlessness. | visits 1-9 |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in HAM-D (17-item) total score | Weeks 1, 2, 3, 5, 6, and 8 |
| Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES) | Weeks 5 and 8 |
| The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics. | Weeks 1, 2, 3, 5, 6, and 8 |
| Change from Baseline in MADRS total score | Weeks 1, 2, 3, 5, 6, and 8 |
Countries
Estonia, Russia
Outcome results
None listed