Cimicoxib for the Treatment of Major Depression (SECIM)

NCT00510822 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 169

Last updated 2013-11-13

No results posted yet for this study

Summary

This multicenter study aims to investigate the safety and efficacy of cimicoxib, a selective COX-2 inhibitor, in combination with sertraline compared to sertraline combined with placebo in patients with major depression. This clinical study is based on the assumption that adjunctive treatment of major depression with a COX-2 inhibitor may be beneficial.

Conditions

Interventions

DRUG

Cimicoxib

50 mg per tablet, bid (total daily dose 100 mg)

DRUG

Placebo

tablet

Sponsors & Collaborators

  • FGK Clinical Research GmbH

    collaborator INDUSTRY
  • Affectis Pharmaceuticals AG

    lead INDUSTRY

Principal Investigators

  • Manfred Rüdiger · Affectis Pharmaceuticals AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • Austria
  • Czechia
  • Germany

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00510822 on ClinicalTrials.gov