Clinical trial NCT00636246: A Comparison of Sertraline-reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Depressive Disorder, Major
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-14
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: visits 1-9
Secondary outcomes:
measure: Change from Baseline in HAM-D (17-item) total score
timeFrame: Weeks 1, 2, 3, 5, 6, and 8
measure: Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)
timeFrame: Weeks 5 and 8
measure: The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics.
timeFrame: Weeks 1, 2, 3, 5, 6, and 8
measure: Change from Baseline in MADRS total score
timeFrame: Weeks 1, 2, 3, 5, 6, and 8
Other outcomes:
Locations:
city: Viljandi
country: Estonia
facility: Pfizer Investigational Site
state: Viljandi Mk.
city: Pärnu
country: Estonia
facility: Pfizer Investigational Site
city: Tallinn
country: Estonia
facility: Pfizer Investigational Site
city: Tartu
country: Estonia
facility: Pfizer Investigational Site
city: Kazan
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Moscow
country: Russian Federation
facility: Pfizer Investigational Site
city: Rostov On Don
country: Russian Federation
facility: Pfizer Investigational Site
city: Smolensk
country: Russian Federation
facility: Pfizer Investigational Site
city: St Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: St. Petersburg
country: Russian Federation
facility: Pfizer Investigational Site
city: Tomsk
country: Russian Federation
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: