Cimicoxib for the Treatment of Major Depression (SECIM)

This study has been completed.
Sponsor:
Collaborator:
FGK Clinical Research GmbH
Information provided by (Responsible Party):
Affectis Pharmaceuticals AG
ClinicalTrials.gov Identifier:
NCT00510822
First received: August 1, 2007
Last updated: November 12, 2013
Last verified: November 2013
  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 2

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

Enrollment: 169
Study Start Date: October 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo + Sertraline
Drug: Placebo
tablet
Other Name: PLC
Experimental: Cimicoxib
Sertraline + Cimicoxib
Drug: Cimicoxib
50 mg per tablet, bid (total daily dose 100 mg)
Other Name: AFX

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Austria
Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie
Klagenfurt, Austria, A-9020
Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH
Salzburg, Austria, A-5020
Czech Republic
Faculty Hospital Brno
Brno, Czech Republic, 639 00
Hospital Ceske Budejovice
Ceske Budejovice, Czech Republic, 370 87
Pardubice Regional Hospital
Pardubice, Czech Republic, 532 03
1st Medical Faculty Prague
Prague, Czech Republic, 120 00
Prague Psychiatric Centrum
Praha, Czech Republic, 181 03
Masaryk Hospital
Ústí nad Labem, Czech Republic, 401 13
Germany
Charite - Center for Psychiatry and Psychotherapy
Berlin, Germany, D-10117
LWL-Universitätsklinik Bochum
Bochum, Germany, 44791
University Bonn, Center for Psychiatry and Psychotherapy
Bonn, Germany, D-53105
Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy
Dresden, Germany, D-01307
Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy
Goettingen, Germany, D-37075
Hospital Guenzburg, Center for Psychosomatic Medicine
Guenzburg, Germany, D-89312
University Jena, Center for Psychiatry and Psychotherapy
Jena, Germany, D-07743
Klinik für Psychiatrie und Psychotherapie der Universität zu Köln
Köln, Germany, 50924
Fachklinik Katzenelnbogen
Limburg an der Lahn (Katzenelnbogen), Germany, 56368
Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine
Magdeburg, Germany, D-39120
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, Germany, 55131
Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie
Mannheim, Germany, 68159
Center for Psychiatry and Psychotherapy, University of Muenster
Muenster, Germany, D-48149
Ludwig-Maximilians University Munich
Munich, Germany, D-80336
Max Planck Institute of Psychiatry
Munich, Germany, D-80804
Bezirksklinikum Regensburg
Regensburg, Germany, 93053
Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy
Stralsund, Germany, D-18437
Sponsors and Collaborators
Affectis Pharmaceuticals AG
FGK Clinical Research GmbH
Investigators
Study Director: Manfred Rüdiger Affectis Pharmaceuticals AG
  More Information

No publications provided

Responsible Party: Affectis Pharmaceuticals AG
ClinicalTrials.gov Identifier: NCT00510822     History of Changes
Other Study ID Numbers: AFX-01, EudraCT-No. 2007-001335-54
Study First Received: August 1, 2007
Last Updated: November 12, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Agency for Health and Food Safety
Czech Republic: State Institute for Drug Control

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

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

ClinicalTrials.gov processed this record on October 29, 2014