A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00636246
First received: March 7, 2008
Last updated: April 3, 2008
Last verified: April 2008
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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
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, 119034 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 127473 | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation | |
| Pfizer Investigational Site | |
| Moscow, Russian Federation, 115522 | |
| 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:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Sertraline Reboxetine Antidepressive Agents Psychotropic Drugs Central Nervous System Agents |
Therapeutic Uses Pharmacologic Actions Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents |
ClinicalTrials.gov processed this record on May 23, 2013