Clinical trial NCT00510822: Cimicoxib for the Treatment of Major Depression (SECIM)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Major Depression
Keywords: Cimicoxib
Cox-2 inhibitor
Sertraline
Lead sponsor: Affectis Pharmaceuticals AG
Sponsor class: INDUSTRY
Collaborators: name: FGK Clinical Research GmbH
First posted: 2007-08-02
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: • Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).
timeFrame: 6 Weeks
Secondary outcomes:
measure: • 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
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Klagenfurt
country: Austria
facility: Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie
city: Salzburg
country: Austria
facility: Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
city: Ceske Budejovice
country: Czech Republic
facility: Hospital Ceske Budejovice
city: Pardubice
country: Czech Republic
facility: Pardubice Regional Hospital
city: Prague
country: Czech Republic
facility: 1st Medical Faculty Prague
city: Praha
country: Czech Republic
facility: Prague Psychiatric Centrum
city: Ústí nad Labem
country: Czech Republic
facility: Masaryk Hospital
city: Berlin
country: Germany
facility: Charite - Center for Psychiatry and Psychotherapy
city: Bochum
country: Germany
facility: LWL-Universitätsklinik Bochum
city: Bonn
country: Germany
facility: University Bonn, Center for Psychiatry and Psychotherapy
city: Dresden
country: Germany
facility: Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy
city: Goettingen
country: Germany
facility: Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy
city: Guenzburg
country: Germany
facility: Hospital Guenzburg, Center for Psychosomatic Medicine
city: Jena
country: Germany
facility: University Jena, Center for Psychiatry and Psychotherapy
city: Köln
country: Germany
facility: Klinik für Psychiatrie und Psychotherapie der Universität zu Köln
city: Limburg an der Lahn (Katzenelnbogen)
country: Germany
facility: Fachklinik Katzenelnbogen
city: Magdeburg
country: Germany
facility: Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine
city: Mainz
country: Germany
facility: Klinikum der Johannes Gutenberg-Universität Mainz
city: Mannheim
country: Germany
facility: Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie
city: Muenster
country: Germany
facility: Center for Psychiatry and Psychotherapy, University of Muenster
city: Munich
country: Germany
facility: Ludwig-Maximilians University Munich
city: Munich
country: Germany
facility: Max Planck Institute of Psychiatry
city: Regensburg
country: Germany
facility: Bezirksklinikum Regensburg
city: Stralsund
country: Germany
facility: Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy
Study officials:
affiliation: Affectis Pharmaceuticals AG
name: Manfred Rüdiger
role: STUDY_DIRECTOR
References: