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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Viljandi, Viljandi mk., 71024 Estonia
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Major Depressive Disorder
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT00636246
Pfizer
Completed
A Comparison of Sertraline-Reboxetine Combination Therapy Versus Sertraline or Reboxetine Monotherapy in the Treatment of Major Depression.

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