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

Depressive Disorder, Major Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00636246
• Other study ID #: A0501075
• Status: Completed
• Phase: Phase 2
• Start date: June 2004
• Est. completion date: August 2005

Study information

• Verified date: January 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 510
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major

Intervention

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.
• 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.
• 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.
• 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
• 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
Tablets, orally once per day for 8 weeks
• 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
• [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

Locations

Country	Name	City	State
Estonia	Pfizer Investigational Site	Pärnu
Estonia	Pfizer Investigational Site	Tallinn
Estonia	Pfizer Investigational Site	Tartu
Estonia	Pfizer Investigational Site	Viljandi	Viljandi Mk.
Russian Federation	Pfizer Investigational Site	Kazan
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Moscow
Russian Federation	Pfizer Investigational Site	Rostov On Don
Russian Federation	Pfizer Investigational Site	Smolensk
Russian Federation	Pfizer Investigational Site	St Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	St. Petersburg
Russian Federation	Pfizer Investigational Site	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Countries where clinical trial is conducted

Estonia,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change from Baseline in HAM-D (17-item) total score		Weeks 1, 2, 3, 5, 6, and 8
Secondary	Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES)		Weeks 5 and 8
Secondary	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
Secondary	Change from Baseline in MADRS total score		Weeks 1, 2, 3, 5, 6, and 8

External Links

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