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

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00636246

Purpose

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	Intervention	Phase
Depressive Disorder, Major	Drug: sertraline/[S,S]-reboxetine Drug: sertraline Drug: Placebo Drug: [S,S]-reboxetine monotherapy	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
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.

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Sertraline hydrochloride Sertraline Reboxetine Reboxetine mesylate

U.S. FDA Resources

Further study details as provided by Pfizer:

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. [ Time Frame: visits 1-9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from Baseline in HAM-D (17-item) total score [ Time Frame: Weeks 1, 2, 3, 5, 6, and 8 ] [ Designated as safety issue: Yes ]
Change from Baseline in the Hamilton Anxiety Rating Scale (HAM-A) and Apathy Evaluation Scale (AES) [ Time Frame: Weeks 5 and 8 ] [ Designated as safety issue: Yes ]
The frequency and severity of treatment-emergent adverse events, ECG changes, laboratory and vital signs changes by treatment group using descriptive statistics. [ Time Frame: Weeks 1, 2, 3, 5, 6, and 8 ] [ Designated as safety issue: No ]
Change from Baseline in MADRS total score [ Time Frame: Weeks 1, 2, 3, 5, 6, and 8 ] [ Designated as safety issue: No ]

Enrollment:	510
Study Start Date:	June 2004
Study Completion Date:	August 2005

Arms	Assigned Interventions
Sertraline/[S,S]-Reboxetine-satellite150/4: Experimental	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-satellite150/6: Experimental	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.
sertraline-satellite: Active Comparator	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.
sertraline-main: Active Comparator	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
Sertraline/[S,S]-Reboxetine-satellite150/2: Experimental	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: Placebo Comparator	Drug: Placebo Tablets, orally once per day for 8 weeks
Sertraline/[S,S]-Reboxetine-main: Experimental	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
[S,S]-reboxetine-main: Active Comparator	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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00636246

Locations

Estonia
Pfizer Investigational Site
Pärnu, Estonia, 80012
Pfizer Investigational Site
Tallinn, Estonia, 10614
Pfizer Investigational Site
Tartu, Estonia, 51008
Estonia, Viljandi mk.
Pfizer Investigational Site
Viljandi, Viljandi mk., Estonia, 71024
Russian Federation
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194214
Pfizer Investigational Site
Moscow, Russian Federation, 119034
Pfizer Investigational Site
St Petersburg, Russian Federation, 190121
Pfizer Investigational Site
St. Petersburg, Russian Federation, 193167
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Kazan, Russian Federation, 420012
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Pfizer Investigational Site
Moscow, Russian Federation, 127473
Pfizer Investigational Site
Moscow, Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 107076
Pfizer Investigational Site
Rostov On Don, Russian Federation, 344010
Pfizer Investigational Site
Tomsk, Russian Federation, 634014
Pfizer Investigational Site
St. Petersburg, Russian Federation, 192019
Russian Federation, RUSSIA
Pfizer Investigational Site
Moscow, RUSSIA, Russian Federation
Russian Federation, Russia
Pfizer Investigational Site
St. Petersburg, Russia, Russian Federation, 192019

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Link to ClinicalStudyResults.org Posting This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Pfizer, Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0501075
Study First Received:	March 7, 2008
Last Updated:	April 3, 2008
ClinicalTrials.gov Identifier:	NCT00636246 History of Changes
Health Authority:	Russia: Ministry of Health, Department of State Quality, Efficacy and Safety Control of Medicines and Medical Technics.

Additional relevant MeSH terms:

Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Depression
Disease
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors

Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Sertraline
Central Nervous System Agents
Antidepressive Agents
Reboxetine

ClinicalTrials.gov processed this record on November 11, 2009