Cimicoxib for the Treatment of Major Depression (SECIM)

Safety and Efficacy of Cimicoxib, a Selective COX-2 Inhibitor, in Combination With Sertraline Compared to Sertraline Combined With Placebo in Treatment of Major Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depression
• Intervention / Treatment: Drug: Placebo; Drug: Cimicoxib

Detailed Description

Adult patients of both gender, aged between 18 and 60 years diagnosed with major depression by a psychiatrist and a HamD-17 score ≥ 22 will be enrolled. All patients will undergo a wash out period of 3 days (without e.g. medication or antidepressant medication) prior to receiving sertraline combined with cimicoxib or placebo. In the exceptional case where in opinion of the investigator concomitant psychotic treatment is needed, up to 3 mg lorazepam daily can additionally be administrated during this period and the first two weeks of treatment.Assessment of HamD-17 will be performed by trained psychiatric raters before wash out and at week 0 (baseline) prior to the treatment. If the HamD-17 score decreases to less than 22 at the second rating patients will be excluded from study.Patient must be in-patients during the wash out period and the first two weeks of treatment. Upon recommendation of the investigator, participants can become out-patients with ambulatory care at day clinics after the first two weeks of treatment.At baseline (week 0) patients will be randomised to one of the following treatment arms:· 50 mg of sertraline (one tablet/unblinded) daily plus cimicoxib (one tablet-50mg) twice daily.· 50 mg of sertraline (one tablet/unblinded) daily plus placebo (one tablet) twice daily If at study visit 3 (i.e. after 3 weeks of treatment) the baseline therapy dose of 50 mg of sertraline daily is considered as not therapeutically sufficient (increase of HamD-17 by more than 20% compared to baseline), it can be increased to 100 mg daily at the discretion of the investigator. The decision by the investigator to increase sertraline dose to 100 mg daily is allowed only at study visit 3 and is not permitted at any other time during the study.During the double-blind period, study visits will take place every week until week 6 and clinical psychiatric and safety assessments will be performed. Four weeks after the end of treatment the investigators or their designees will call the patients to capture information on how the patients feel and to assess if the patients experienced any SAE/AEs (e.g. hospitalisations).

• Study Type: Interventional
• Enrollment (Actual): 169
• Phase: Phase 2

Contacts and Locations

Study Locations

• Austria
  • Klagenfurt, Austria, A-9020
    • Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie
  • Salzburg, Austria, A-5020
    • Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH
• Czech Republic
  • Brno, Czech Republic, 639 00
    • Faculty Hospital Brno
  • Ceske Budejovice, Czech Republic, 370 87
    • Hospital Ceské Budejovice
  • Pardubice, Czech Republic, 532 03
    • Pardubice Regional Hospital
  • Prague, Czech Republic, 120 00
    • 1st Medical Faculty Prague
  • Praha, Czech Republic, 181 03
    • Prague Psychiatric Centrum
  • Ústí nad Labem, Czech Republic, 401 13
    • Masaryk Hospital
• Germany
  • Berlin, Germany, D-10117
    • Charite - Center for Psychiatry and Psychotherapy
  • Bochum, Germany, 44791
    • LWL-Universitätsklinik Bochum
  • Bonn, Germany, D-53105
    • University Bonn, Center for Psychiatry and Psychotherapy
  • Dresden, Germany, D-01307
    • Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy
  • Goettingen, Germany, D-37075
    • Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy
  • Guenzburg, Germany, D-89312
    • Hospital Guenzburg, Center for Psychosomatic Medicine
  • Jena, Germany, D-07743
    • University Jena, Center for Psychiatry and Psychotherapy
  • Köln, Germany, 50924
    • Klinik für Psychiatrie und Psychotherapie der Universität zu Köln
  • Limburg an der Lahn (Katzenelnbogen), Germany, 56368
    • Fachklinik Katzenelnbogen
  • Magdeburg, Germany, D-39120
    • Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine
  • Mainz, Germany, 55131
    • Klinikum der Johannes Gutenberg-Universität Mainz
  • Mannheim, Germany, 68159
    • Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie
  • Muenster, Germany, D-48149
    • Center for Psychiatry and Psychotherapy, University of Muenster
  • Munich, Germany, D-80336
    • Ludwig-Maximilians University Munich
  • Munich, Germany, D-80804
    • Max Planck Institute of Psychiatry
  • Regensburg, Germany, 93053
    • Bezirksklinikum Regensburg
  • Stralsund, Germany, D-18437
    • Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo + Sertraline	Drug: Placebo; tablet; Other Names: PLC
Experimental: Cimicoxib; Sertraline + Cimicoxib	Drug: Cimicoxib; 50 mg per tablet, bid (total daily dose 100 mg); Other Names: AFX

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).	6 Weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
• Changes from baseline to interim weekly visits (week 1 to 5) in HamD-17 score • Clinical Global Impression (CGI) score • Montgomery Asberg Depression Rating Scale (MADRS) score • Response rate, remission rate and drop out rate. • Onset of	6 weeks

Collaborators and Investigators

• Sponsor: Affectis Pharmaceuticals AG
• Collaborators: FGK Clinical Research GmbH
• Investigators: Study Director: Manfred Rüdiger, Affectis Pharmaceuticals AG

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: August 1, 2007
• First Submitted That Met QC Criteria: August 1, 2007
• First Posted (Estimate): August 2, 2007

Study Record Updates

• Last Update Posted (Estimate): November 13, 2013
• Last Update Submitted That Met QC Criteria: November 12, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: Sertraline; Cox-2 inhibitor; Cimicoxib
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: AFX-01; EudraCT-No. 2007-001335-54