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

Condition(s) targeted: Depressive Disorder, Major

Intervention: sertraline/[S,S]-reboxetine (Drug); sertraline/[S,S]-reboxetine (Drug); sertraline (Drug); sertraline (Drug); sertraline/[S,S]-reboxetine (Drug); Placebo (Drug); sertraline/[S,S]-reboxetine (Drug); [S,S]-reboxetine monotherapy (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

Official title: 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.

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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.

Secondary outcome:

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

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

The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.

Change from Baseline in MADRS total score

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Pfizer Investigational Site, Pärnu 80012, Estonia

Pfizer Investigational Site, Tallinn 10614, Estonia

Pfizer Investigational Site, Tartu 51008, Estonia

Pfizer Investigational Site, Moscow 115522, Russian Federation

Pfizer Investigational Site, Moscow 119034, Russian Federation

Pfizer Investigational Site, St Petersburg 190121, Russian Federation

Pfizer Investigational Site, St. Petersburg 193167, Russian Federation

Pfizer Investigational Site, St. Petersburg 194214, Russian Federation

Pfizer Investigational Site, Kazan 420012, Russian Federation

Pfizer Investigational Site, Smolensk 214019, Russian Federation

Pfizer Investigational Site, Moscow 127473, Russian Federation

Pfizer Investigational Site, Moscow, Russian Federation

Pfizer Investigational Site, Moscow 107076, Russian Federation

Pfizer Investigational Site, Rostov On Don 344010, Russian Federation

Pfizer Investigational Site, Tomsk 634014, Russian Federation

Pfizer Investigational Site, St. Petersburg 192019, Russian Federation

Pfizer Investigational Site, Moscow, RUSSIA, Russian Federation

Pfizer Investigational Site, St. Petersburg, Russia 192019, Russian Federation

Pfizer Investigational Site, Viljandi, Viljandi mk. 71024, Estonia

To obtain contact information for a study center near you, click here.

Link to ClinicalStudyResults.org Posting

Starting date: June 2004
Ending date: August 2005
Last updated: April 3, 2008