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

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00636246

Collaborator

(none)

510

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder, Major	Drug: 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	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

510 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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 Start Date :

Jun 1, 2004

Actual Study Completion Date :

Aug 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sertraline/[S,S]-Reboxetine-satellite150/4	Drug: sertraline/[S,S]-reboxetine 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.
Experimental: Sertraline/[S,S]-Reboxetine-satellite150/6	Drug: sertraline/[S,S]-reboxetine 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/6mg [S,S]-reboxetine for 5 and one half weeks.
Active Comparator: sertraline-satellite	Drug: sertraline 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.
Active Comparator: sertraline-main	Drug: sertraline 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
Experimental: Sertraline/[S,S]-Reboxetine-satellite150/2	Drug: sertraline/[S,S]-reboxetine Tablets, 50mg sertraline/2mg [S,S]-reboxetine for 3 days orally, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks.
Placebo Comparator: Placebo	Drug: Placebo Tablets, orally once per day for 8 weeks
Experimental: Sertraline/[S,S]-Reboxetine-main	Drug: sertraline/[S,S]-reboxetine Tablets, 50mg sertraline/2mg [S,S]-reboxetine orally for 3 days, followed by 100mg sertraline/2mg [S,S]-reboxetine for 4 and one half weeks, followed by 150mg sertraline/2mg [S,S]-reboxetine for 5 and one half weeks
Active Comparator: [S,S]-reboxetine-main	Drug: [S,S]-reboxetine monotherapy Tablets, 2 mg/day orally for 3 days, followed by 4 mg/day orally for 4 and one half weeks, followed by 6mg/day for 3 weeks

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Viljandi	Viljandi Mk.	Estonia	71024
2	Pfizer Investigational Site	Pärnu		Estonia	80012
3	Pfizer Investigational Site	Tallinn		Estonia	10614
4	Pfizer Investigational Site	Tartu		Estonia	51008
5	Pfizer Investigational Site	Kazan		Russian Federation	420012
6	Pfizer Investigational Site	Moscow		Russian Federation	107076
7	Pfizer Investigational Site	Moscow		Russian Federation	115522
8	Pfizer Investigational Site	Moscow		Russian Federation	119034
9	Pfizer Investigational Site	Moscow		Russian Federation	127473
10	Pfizer Investigational Site	Moscow		Russian Federation
11	Pfizer Investigational Site	Rostov On Don		Russian Federation	344010
12	Pfizer Investigational Site	Smolensk		Russian Federation	214019
13	Pfizer Investigational Site	St Petersburg		Russian Federation	190121
14	Pfizer Investigational Site	St. Petersburg		Russian Federation	192019
15	Pfizer Investigational Site	St. Petersburg		Russian Federation	193167
16	Pfizer Investigational Site	St. Petersburg		Russian Federation	194214
17	Pfizer Investigational Site	Tomsk		Russian Federation	634014