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

Viatris

Status and phase

Completed

Phase 2

Conditions

Depressive Disorder, Major

Treatments

Drug: Placebo

Drug: sertraline/[S,S]-reboxetine

Drug: sertraline

Drug: [S,S]-reboxetine monotherapy

Study type

Interventional

Funder types

Industry

Identifiers

NCT00636246

A0501075

Details and patient eligibility

About

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.

Enrollment

510 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

510 participants in 8 patient groups, including a placebo group

Sertraline/[S,S]-Reboxetine-satellite150/4

Experimental group

Treatment:

Drug: sertraline/[S,S]-reboxetine

Sertraline/[S,S]-Reboxetine-satellite150/6

Experimental group

Treatment:

Drug: sertraline/[S,S]-reboxetine

sertraline-satellite

Active Comparator group

Treatment:

Drug: sertraline

sertraline-main

Active Comparator group

Treatment:

Drug: sertraline

Sertraline/[S,S]-Reboxetine-satellite150/2

Experimental group

Treatment:

Drug: sertraline/[S,S]-reboxetine

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Sertraline/[S,S]-Reboxetine-main

Experimental group

Treatment:

Drug: sertraline/[S,S]-reboxetine

[S,S]-reboxetine-main

Active Comparator group

Treatment:

Drug: [S,S]-reboxetine monotherapy

Trial contacts and locations

17

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