Cimicoxib for the Treatment of Major Depression (SECIM)

Condition(s) targeted: Major Depression

Intervention: Cimicoxib (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Affectis Pharmaceuticals AG

Official(s) and/or principal investigator(s):
Herbert Stadler, Dr., Study Director, Affiliation: Affectis Pharmaceuticals AG

Overall contact:
Herbert Stadler, MD, Phone: +49-89 3281 1, Ext: 100, Email: stadler@affectis.com

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.

Official title: 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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: • Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).

Secondary outcome: • 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

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).

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Herbert Stadler, MD, Phone: +49-89 3281 1, Ext: 100, Email: stadler@affectis.com

Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie, Klagenfurt A-9020, Austria; Recruiting
Josef Marksteiner, Prof. Dr., Phone: 0463 538 229, Ext: 70, Email: josef.marksteiner@kabeg.at
Josef Marksteiner, Prof. Dr., Principal Investigator

Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH, Salzburg A-5020, Austria; Recruiting
Christian Geretsegger, Dr., Phone: 0043-622-4483, Email: c.geretsegger@salk.at
Christian Geretsegger, Dr., Principal Investigator

Pardubice Regional Hospital, Pardubice 532 03, Czech Republic; Recruiting
Jan Kolomaznik, MD, Phone: +420 466 016 601, Ext: 7, Email: jan.kolomaznik@nem.pce.cz
Jan Kolomaznik, MD, Principal Investigator

Prague Psychiatric Centrum, Praha 181 03, Czech Republic; Recruiting
Martin Bares, MD, Phone: +420 266 003, Ext: 330, Email: bares@pcp.lf3.cuni.cz
Martin Bares, MD, Principal Investigator

1st Medical Faculty Prague, Prague 120 00, Czech Republic; Recruiting
Jiri Raboch, MD, Phone: +420 224 965, Ext: 358, Email: eva.kitzlerova@centrum.cz
Jiri Raboch, MD, Principal Investigator

Faculty Hospital Brno, Brno 639 00, Czech Republic; Recruiting
Eva Cešková, MD, Phone: +420 532 232, Ext: 055, Email: radovan.prikryl@post.cz
Eva Cešková, MD, Principal Investigator

Hospital Ceske Budejovice, Ceske Budejovice 370 87, Czech Republic; Recruiting
Jan Tucek, MD, Phone: +420 38 787 8, Ext: 700, Email: tucek@nemcb.cz
Jan Tucek, MD, Principal Investigator

Masaryk Hospital, Ústí nad Labem 401 13, Czech Republic; Recruiting
Zdenka Stankova, MD, Phone: +420 602 442, Ext: 767, Email: zdenka.Stankova@mnul.cz
Zdenka Stankova, MD, Principal Investigator

Ludwig-Maximilians University Munich, Munich D-80336, Germany; Recruiting
Norbert Müller, Phone: +49-89-5160-3397
Norbert Müller, Prof. Dr., Principal Investigator

Max Planck Institute of Psychiatry, Munich D-80804, Germany; Recruiting
Thomas Nickel, MD, Phone: +4989-30622-572
Thomas Nickel, Dr., Principal Investigator

Center for Psychiatry and Psychotherapy, University of Muenster, Muenster D-48149, Germany; Recruiting
Matthias Rothermundt, MD, Phone: +490251 / 83-52581
Matthias Rothermundt, PD Dr., Principal Investigator

Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy, Goettingen D-37075, Germany; Recruiting
Harald Scherk, MD, Phone: +490551-39-66-10
Harald Scherk, Dr., Principal Investigator

Hospital Guenzburg, Center for Psychosomatic Medicine, Guenzburg D-89312, Germany; Recruiting
Karl Bechter, MD, Phone: +4949-8221 / 96-2540
Karl Bechter, Prof. Dr., Principal Investigator

Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine, Magdeburg D-39120, Germany; Recruiting
Bernhard Bogerts, MD, Phone: +49-391-67-15029
Bernhard Bogerts, Prof. Dr., Principal Investigator

Charite - Center for Psychiatry and Psychotherapy, Berlin D-10117, Germany; Recruiting
Ion Anghelescu, MD, Phone: +49 030 8445-8429
Ion Anghelescu, Prof. Dr., Principal Investigator

University Bonn, Center for Psychiatry and Psychotherapy, Bonn D-53105, Germany; Recruiting
Wolfgang Maier, Phone: +490228 / 287-15722
Wolfgang Maier, Prof. Dr., Principal Investigator

Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy, Stralsund D-18437, Germany; Recruiting
Harald Freyberger, MD, Phone: +4903831 4521-00
Harald Freyberger, Prof. Dr., Principal Investigator

Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy, Dresden D-01307, Germany; Recruiting
Michael Bauer, MD, Phone: +49 0351 458-27 60
Michael Bauer, Prof Dr. Dr., Principal Investigator

University Jena, Center for Psychiatry and Psychotherapy, Jena D-07743, Germany; Recruiting
Ralf Schloesser, MD, Phone: +490341-935284
Ralf Schloesser, PD Dr., Principal Investigator

Klinikum der Johannes Gutenberg-Universität Mainz, Mainz 55131, Germany; Recruiting
André Tadic, MD, Phone: +49 06131-17-7335, Email: klaus.lieb@ukmainz.de
André Tadic, MD, Principal Investigator

Fachklinik Katzenelnbogen, Limburg an der Lahn (Katzenelnbogen) 56368, Germany; Recruiting
Norbert Dahmen, MD, Phone: +49 01805 355607 - 1047, Email: ndahmen@uni-mainz.de
Norbert Dahmen, MD, Principal Investigator

LWL-Universitätsklinik Bochum, Bochum 44791, Germany; Recruiting
Georg Juckel, MD, Phone: +49 0234-5077-201, Email: georg.juckel@wkp-lwl.org
Georg Juckel, MD, Principal Investigator

Bezirksklinikum Regensburg, Regensburg 93053, Germany; Recruiting
Göran Hajak, MD, Phone: +49 0941 941 1001, Email: Marion.Miedel@medbo.de
Göran Hajak, MD, Principal Investigator

Klinik für Psychiatrie und Psychotherapie der Universität zu Köln, Köln 50924, Germany; Recruiting
Dagmar Koethe, Dr., Phone: 0221-478-862, Ext: 31, Email: koethe@ecnp.net
Dagmar Koethe, MD, Principal Investigator

Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie, Mannheim 68159, Germany; Recruiting
Dagmar Koethe, Dr., Principal Investigator

Starting date: October 2007
Ending date: December 2009
Last updated: June 17, 2009