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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00636246
First received: March 7, 2008
Last updated: April 3, 2008
Last verified: April 2008
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


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
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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Estonia
Pfizer Investigational Site
Viljandi, Viljandi mk., Estonia, 71024
Pfizer Investigational Site
Pärnu, Estonia, 80012
Pfizer Investigational Site
Tallinn, Estonia, 10614
Pfizer Investigational Site
Tartu, Estonia, 51008
Russian Federation
Pfizer Investigational Site
Moscow, Russia, Russian Federation
Pfizer Investigational Site
St. Petersburg, Russia, Russian Federation, 192019
Pfizer Investigational Site
Kazan, Russian Federation, 420012
Pfizer Investigational Site
Moscow, Russian Federation, 115522
Pfizer Investigational Site
Moscow, Russian Federation, 119034
Pfizer Investigational Site
Moscow, Russian Federation
Pfizer Investigational Site
Moscow, Russian Federation, 127473
Pfizer Investigational Site
Moscow, Russian Federation, 107076
Pfizer Investigational Site
Rostov On Don, Russian Federation, 344010
Pfizer Investigational Site
Smolensk, Russian Federation, 214019
Pfizer Investigational Site
St Petersburg, Russian Federation, 190121
Pfizer Investigational Site
St. Petersburg, Russian Federation, 194214
Pfizer Investigational Site
St. Petersburg, Russian Federation, 192019
Pfizer Investigational Site
St. Petersburg, Russian Federation, 193167
Pfizer Investigational Site
Tomsk, Russian Federation, 634014
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Reboxetine
Sertraline
Adrenergic Agents
Adrenergic Uptake Inhibitors
Antidepressive Agents
Central Nervous System Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014