| A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression. |
| Sertraline/[S,S]-Reboxetine Combination Versus Sertraline And [S,S]-Reboxetine Monotherapy In Major Depressive Disorder (MDD) In A Double-Blind, Placebo-Controlled, Eight Week Study. |
| 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. |
| Not Provided |
| Interventional |
| Phase 2 |
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment |
| Depressive Disorder, Major |
- Drug: sertraline/[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.
- Drug: sertraline/[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/6mg [S,S]-reboxetine for 5 and one half weeks.
- Drug: sertraline
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.
- Drug: sertraline
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
- Drug: sertraline/[S,S]-reboxetine
Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
- Drug: Placebo
Tablets, orally once per day for 8 weeks
- Drug: sertraline/[S,S]-reboxetine
Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half 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
|
- Experimental: Sertraline/[S,S]-Reboxetine-satellite150/4
Intervention: Drug: sertraline/[S,S]-reboxetine
- Experimental: Sertraline/[S,S]-Reboxetine-satellite150/6
Intervention: Drug: sertraline/[S,S]-reboxetine
- Active Comparator: sertraline-satellite
Intervention: Drug: sertraline
- Active Comparator: sertraline-main
Intervention: Drug: sertraline
- Experimental: Sertraline/[S,S]-Reboxetine-satellite150/2
Intervention: Drug: sertraline/[S,S]-reboxetine
- Placebo Comparator: Placebo
Intervention: Drug: Placebo
- Experimental: Sertraline/[S,S]-Reboxetine-main
Intervention: Drug: sertraline/[S,S]-reboxetine
- Active Comparator: [S,S]-reboxetine-main
Intervention: Drug: [S,S]-reboxetine monotherapy
|
| Not Provided |
| |
| Completed |
| 510 |
| August 2005 |
| Not Provided |
|
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.
|
| Sexes Eligible for Study: |
All |
|
| 18 Years to 65 Years (Adult) |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| Estonia, Russian Federation |
| |
| |
| NCT00636246 |
| A0501075 |
| No |
| Not Provided |
| Not Provided |
| Director, Clinical Trial Disclosure Group, Pfizer, Inc |
| Pfizer |
| Not Provided |
| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
|
| Pfizer |
| April 2008 |
