A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

Phase 2

Completed

• Conditions: Depressive Disorder, Major
• Interventions: Drug: sertraline/[S,S]-reboxetine; Drug: Placebo; Drug: [S,S]-reboxetine monotherapy; Drug: sertraline

• Registration Number: NCT00636246
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-06
• Study Completion: 2005-08
• Study First Submitted: 2008-03-07
• Study First Submitted QC: 2008-03-07
• Study First Posted: 2008-03-14
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 510

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sertraline/[S,S]-Reboxetine-satellite150/2	sertraline/[S,S]-reboxetine	-
Sertraline/[S,S]-Reboxetine-satellite150/4	sertraline/[S,S]-reboxetine	-
Sertraline/[S,S]-Reboxetine-satellite150/6	sertraline/[S,S]-reboxetine	-
Placebo	Placebo	-
Sertraline/[S,S]-Reboxetine-main	sertraline/[S,S]-reboxetine	-
[S,S]-reboxetine-main	[S,S]-reboxetine monotherapy	-
sertraline-main	sertraline	-
sertraline-satellite	sertraline	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇷🇺 Tomsk, Russian Federation