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| 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 |
| 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)
|
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 |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations| 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 |
| 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. | |
| Study Director: | Herbert Stadler, Dr. | Affectis Pharmaceuticals AG |
More Information
| 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 |
|
Cimicoxib Cox-2 inhibitor Sertraline |
|
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 |