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Cimicoxib for the Treatment of Major Depression (SECIM)
This study is currently recruiting participants.
Verified by Affectis Pharmaceuticals AG, June 2008
First Received: August 1, 2007   Last Updated: February 3, 2010   History of Changes
Sponsor: Affectis Pharmaceuticals AG
Collaborator: FGK Clinical Research GmbH
Information provided by: Affectis Pharmaceuticals AG
ClinicalTrials.gov Identifier: NCT00510822
  Purpose

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.


Condition Intervention Phase
Major Depression
Drug: Cimicoxib
Drug: Placebo
Phase II

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

Resource links provided by NLM:


Further study details as provided by Affectis Pharmaceuticals AG:

Primary Outcome Measures:
  • • Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6). [ Time Frame: 6 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • 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 [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: October 2007
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo: Placebo Comparator
Placebo + Sertraline
Drug: Placebo
tablet
Cimicoxib: Experimental
Sertraline + Cimicoxib
Drug: Cimicoxib
50 mg per tablet, bid (total daily dose 100 mg)

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).

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510822

Contacts
Contact: Herbert Stadler, MD +49-89 3281 1 ext 100 stadler@affectis.com
Contact: Yvonne Tretter, Dr. +49-89 893119 ext 16 yvonne.tretter@fgk-cro.de

Locations
Austria
Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie Recruiting
Klagenfurt, Austria, A-9020
Contact: Josef Marksteiner, Prof. Dr.     0463 538 229 ext 70     josef.marksteiner@kabeg.at    
Principal Investigator: Josef Marksteiner, Prof. Dr.            
Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH Recruiting
Salzburg, Austria, A-5020
Contact: Christian Geretsegger, Dr.     0043-622-4483 ext 0     c.geretsegger@salk.at    
Principal Investigator: Christian Geretsegger, Dr.            
Czech Republic
Pardubice Regional Hospital Recruiting
Pardubice, Czech Republic, 532 03
Contact: Jan Kolomaznik, MD     +420 466 016 601 ext 7     jan.kolomaznik@nem.pce.cz    
Principal Investigator: Jan Kolomaznik, MD            
Prague Psychiatric Centrum Recruiting
Praha, Czech Republic, 181 03
Contact: Martin Bares, MD     +420 266 003 ext 330     bares@pcp.lf3.cuni.cz    
Principal Investigator: Martin Bares, MD            
Masaryk Hospital Recruiting
Ústí Nad Labem, Czech Republic, 401 13
Contact: Zdenka Stankova, MD     +420 602 442 ext 767     zdenka.Stankova@mnul.cz    
Principal Investigator: Zdenka Stankova, MD            
Faculty Hospital Brno Recruiting
Brno, Czech Republic, 639 00
Contact: Eva Cešková, MD     +420 532 232 ext 055     radovan.prikryl@post.cz    
Principal Investigator: Eva Cešková, MD            
Hospital Ceske Budejovice Recruiting
Ceske Budejovice, Czech Republic, 370 87
Contact: Jan Tucek, MD     +420 38 787 8 ext 700     tucek@nemcb.cz    
Principal Investigator: Jan Tucek, MD            
1st Medical Faculty Prague Recruiting
Prague, Czech Republic, 120 00
Contact: Jiri Raboch, MD     +420 224 965 ext 358     eva.kitzlerova@centrum.cz    
Principal Investigator: Jiri Raboch, MD            
Germany
Ludwig-Maximilians University Munich Recruiting
Munich, Germany, D-80336
Contact: Norbert Müller     +49-89-5160-3397        
Principal Investigator: Norbert Müller, Prof. Dr.            
Max Planck Institute of Psychiatry Recruiting
Munich, Germany, D-80804
Contact: Thomas Nickel, MD     +4989-30622-572        
Principal Investigator: Thomas Nickel, Dr.            
Center for Psychiatry and Psychotherapy, University of Muenster Recruiting
Muenster, Germany, D-48149
Contact: Matthias Rothermundt, MD     +490251 / 83-52581        
Principal Investigator: Matthias Rothermundt, PD Dr.            
Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy Recruiting
Goettingen, Germany, D-37075
Contact: Harald Scherk, MD     +490551-39-66-10        
Principal Investigator: Harald Scherk, Dr.            
Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie Recruiting
Mannheim, Germany, 68159
Principal Investigator: Dagmar Koethe, Dr.            
Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine Recruiting
Magdeburg, Germany, D-39120
Contact: Bernhard Bogerts, MD     +49-391-67-15029        
Principal Investigator: Bernhard Bogerts, Prof. Dr.            
Charite - Center for Psychiatry and Psychotherapy Recruiting
Berlin, Germany, D-10117
Contact: Ion Anghelescu, MD     +49 030 8445-8429        
Principal Investigator: Ion Anghelescu, Prof. Dr.            
University Bonn, Center for Psychiatry and Psychotherapy Recruiting
Bonn, Germany, D-53105
Contact: Wolfgang Maier     +490228 / 287-15722        
Principal Investigator: Wolfgang Maier, Prof. Dr.            
Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy Recruiting
Stralsund, Germany, D-18437
Contact: Harald Freyberger, MD     +4903831 4521-00        
Principal Investigator: Harald Freyberger, Prof. Dr.            
Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy Recruiting
Dresden, Germany, D-01307
Contact: Michael Bauer, MD     +49 0351 458-27 60        
Principal Investigator: Michael Bauer, Prof Dr. Dr.            
University Jena, Center for Psychiatry and Psychotherapy Recruiting
Jena, Germany, D-07743
Contact: Ralf Schloesser, MD     +490341-935284        
Principal Investigator: Ralf Schloesser, PD Dr.            
Klinikum der Johannes Gutenberg-Universität Mainz Recruiting
Mainz, Germany, 55131
Contact: André Tadic, MD     +49 06131-17-7335     klaus.lieb@ukmainz.de    
Principal Investigator: André Tadic, MD            
Fachklinik Katzenelnbogen Recruiting
Limburg An Der Lahn (Katzenelnbogen), Germany, 56368
Contact: Norbert Dahmen, MD     +49 01805 355607 - 1047     ndahmen@uni-mainz.de    
Principal Investigator: Norbert Dahmen, MD            
LWL-Universitätsklinik Bochum Recruiting
Bochum, Germany, 44791
Contact: Georg Juckel, MD     +49 0234-5077-201     georg.juckel@wkp-lwl.org    
Principal Investigator: Georg Juckel, MD            
Bezirksklinikum Regensburg Recruiting
Regensburg, Germany, 93053
Contact: Göran Hajak, MD     +49 0941 941 1001     Marion.Miedel@medbo.de    
Principal Investigator: Göran Hajak, MD            
Klinik für Psychiatrie und Psychotherapie der Universität zu Köln Recruiting
Köln, Germany, 50924
Contact: Dagmar Koethe, Dr.     0221-478-862 ext 31     koethe@ecnp.net    
Principal Investigator: Dagmar Koethe, MD            
Hospital Guenzburg, Center for Psychosomatic Medicine Recruiting
Guenzburg, Germany, D-89312
Contact: Karl Bechter, MD     +4949-8221 / 96-2540        
Principal Investigator: Karl Bechter, Prof. Dr.            
Sponsors and Collaborators
Affectis Pharmaceuticals AG
FGK Clinical Research GmbH
Investigators
Study Director: Herbert Stadler, Dr. Affectis Pharmaceuticals AG
  More Information

No publications provided

Responsible Party: Affectis Pharmaceuticals AG ( Dr. Herbert Stadler )
Study ID Numbers: AFX-01, EudraCT-No. 2007-001335-54
Study First Received: August 1, 2007
Last Updated: February 3, 2010
ClinicalTrials.gov Identifier: NCT00510822     History of Changes
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Affectis Pharmaceuticals AG:
Cimicoxib
Cox-2 inhibitor
Sertraline

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Cyclooxygenase 2 Inhibitors
Mental Disorders
Sensory System Agents
Therapeutic Uses
Sertraline
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Antidepressive Agents
Depression
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Serotonin Agents
Analgesics, Non-Narcotic
Mood Disorders
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010