Cimicoxib for the Treatment of Major Depression (SECIM)

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Affectis Pharmaceuticals AG
• Collaborator: FGK Clinical Research GmbH
• Treatments: Cyclooxygenase 2 Inhibitors; Sertraline

Criteria

Inclusion Criteria:

• Major depression diagnosed by psychiatrist

• DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode

• HamD-17 score ≥ 22

Exclusion Criteria:

• Psychotic depression, bipolar disorder, obsessive compulsive disorder, anxiety disorder, personality disorder, drug or alcohol abuse, schizoaffective disorders, schizophrenia

• All DSM IV TR Axis-I disorders except depression

• All DSM IV TR Axis-II disorders without exception

• Unsuccessful treatment with more than 2 antidepressant medications

• Concomitant use of psychotropic drugs, including mood stabilizers

• Immediate risk of suicidal behaviour

• Women who are pregnant, breast feeding or planning to become pregnant during the course of study, Women who are not post-menopausal, surgically sterilized or using an effective method of contraception

• Any history of cardiovascular disease (e.g. angina, heart attack, stroke, congestive heart failure), uncontrolled high blood pressure, documented peripheral arterial insufficiency and symptomatic, clinically significant claudication, or a history of peripheral arterial embolism

• History of coronary heart disease (CHD) or any other heart disease

• History of upper or lower gastrointestinal (GI) ulceration, perforation and/or obstruction

• History of upper or lower GI bleeding within the previous year

• History of inflammatory bowel disease

Other protocol-defined inclusion/exclusion criteria may apply