Cimicoxib for the Treatment of Major Depression (SECIM)

Major Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510822
• Other study ID #: AFX-01
• Secondary ID: EudraCT-No. 2007
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2007
• Last updated: November 12, 2013
• Start date: October 2007
• Est. completion date: February 2010

Study information

• Verified date: November 2013
• Source: Affectis Pharmaceuticals AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Agency for Health and Food SafetyCzech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

Drug:
• Cimicoxib
50 mg per tablet, bid (total daily dose 100 mg)
• Placebo
tablet

Locations

Country	Name	City	State
Austria	Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie	Klagenfurt
Austria	Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH	Salzburg
Czech Republic	Faculty Hospital Brno	Brno
Czech Republic	Hospital Ceske Budejovice	Ceske Budejovice
Czech Republic	Pardubice Regional Hospital	Pardubice
Czech Republic	1st Medical Faculty Prague	Prague
Czech Republic	Prague Psychiatric Centrum	Praha
Czech Republic	Masaryk Hospital	Ústí nad Labem
Germany	Charite - Center for Psychiatry and Psychotherapy	Berlin
Germany	LWL-Universitätsklinik Bochum	Bochum
Germany	University Bonn, Center for Psychiatry and Psychotherapy	Bonn
Germany	Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy	Dresden
Germany	Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy	Goettingen
Germany	Hospital Guenzburg, Center for Psychosomatic Medicine	Guenzburg
Germany	University Jena, Center for Psychiatry and Psychotherapy	Jena
Germany	Klinik für Psychiatrie und Psychotherapie der Universität zu Köln	Köln
Germany	Fachklinik Katzenelnbogen	Limburg an der Lahn (Katzenelnbogen)
Germany	Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine	Magdeburg
Germany	Klinikum der Johannes Gutenberg-Universität Mainz	Mainz
Germany	Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie	Mannheim
Germany	Center for Psychiatry and Psychotherapy, University of Muenster	Muenster
Germany	Ludwig-Maximilians University Munich	Munich
Germany	Max Planck Institute of Psychiatry	Munich
Germany	Bezirksklinikum Regensburg	Regensburg
Germany	Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy	Stralsund

Sponsors (2)

Lead Sponsor	Collaborator
Affectis Pharmaceuticals AG	FGK Clinical Research GmbH

Countries where clinical trial is conducted

Austria,  Czech Republic,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).		6 Weeks	No
Secondary	• 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	Yes