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

NCT00636246 | Completed Phase 2

• 1 other identifier: A0501075
• Study Type: interventional
• Target: 510
• Locations: 2 countries
• Sites: 17

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (8)

Sertraline/[S,S]-Reboxetine-satellite150/4

EXPERIMENTAL

Drug: sertraline/[S,S]-reboxetine

Sertraline/[S,S]-Reboxetine-satellite150/6

EXPERIMENTAL

Drug: sertraline/[S,S]-reboxetine

sertraline-satellite

ACTIVE COMPARATOR

Drug: sertraline

sertraline-main

ACTIVE COMPARATOR

Drug: sertraline

Sertraline/[S,S]-Reboxetine-satellite150/2

EXPERIMENTAL

Drug: sertraline/[S,S]-reboxetine

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Sertraline/[S,S]-Reboxetine-main

EXPERIMENTAL

Drug: sertraline/[S,S]-reboxetine

[S,S]-reboxetine-main

ACTIVE COMPARATOR

Drug: [S,S]-reboxetine monotherapy

Interventions

sertraline/[S,S]-reboxetine DRUG

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-satellite150/4

sertraline DRUG

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-satellite

Placebo DRUG

Tablets, orally once per day for 8 weeks

Placebo

[S,S]-reboxetine monotherapy DRUG

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

[S,S]-reboxetine-main

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Study Sites (17)

Pfizer Investigational Site

Viljandi, Viljandi Mk., 71024, Estonia

Location

Pfizer Investigational Site

Pärnu, 80012, Estonia

Location

Pfizer Investigational Site

Tallinn, 10614, Estonia

Location

Pfizer Investigational Site

Tartu, 51008, Estonia

Location

Pfizer Investigational Site

Kazan', 420012, Russia

Location

Pfizer Investigational Site

Moscow, 107076, Russia

Location

Pfizer Investigational Site

Moscow, 115522, Russia

Location

Pfizer Investigational Site

Moscow, 119034, Russia

Location

Pfizer Investigational Site

Moscow, 127473, Russia

Location

Pfizer Investigational Site

Moscow, Russia

Location

Pfizer Investigational Site

Rostov-on-Don, 344010, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 190121, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 192019, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 193167, Russia

Location

Pfizer Investigational Site

Saint Petersburg, 194214, Russia

Location

Pfizer Investigational Site

Smolensk, 214019, Russia

Location

Pfizer Investigational Site

Tomsk, 634014, Russia

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2008
• First Posted: March 14, 2008
• Study Start: June 1, 2004
• Study Completion: August 1, 2005
• Last Updated: January 28, 2021

Record last verified: 2021-01

Locations

ES (4); RU (13)