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

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.510 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

510

Conditions

Depressive Disorder, Major

Interventions

sertraline/[S,S]-reboxetineDRUG

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.

sertraline/[S,S]-reboxetineDRUG

sertralineDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (17)

Pfizer Investigational Site

Viljandi, Viljandi Mk., Estonia

Pfizer Investigational Site

Pärnu, Estonia

Pfizer Investigational Site

Outcomes

Primary Outcomes

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.

Time frame: visits 1-9

Secondary Outcomes

Change from Baseline in HAM-D (17-item) total score

Time frame: Weeks 1, 2, 3, 5, 6, and 8

Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)

Time frame: 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.

Time frame: Weeks 1, 2, 3, 5, 6, and 8

Change from Baseline in MADRS total score

Time frame: Weeks 1, 2, 3, 5, 6, and 8

Data from ClinicalTrials.gov

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