Cimicoxib for the Treatment of Major Depression (SECIM)

NCT00510822 | Completed Phase 2

• 2 other identifiers: AFX-01EudraCT-No. 2007-001335-54
• Study Type: interventional
• Target: 169
• Locations: 3 countries
• Sites: 25

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.

Conditions

Major Depression

Keywords

Cimicoxib; Cox-2 inhibitor; Sertraline

Outcome Measures

Primary Outcomes (1)

• • Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).

  6 Weeks

Secondary Outcomes (1)

• • 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

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo + Sertraline

Drug: Placebo

Cimicoxib

EXPERIMENTAL

Sertraline + Cimicoxib

Drug: Cimicoxib

Interventions

Cimicoxib DRUG

50 mg per tablet, bid (total daily dose 100 mg)

Also known as: AFX

Cimicoxib

Placebo DRUG

tablet

Also known as: PLC

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Major depression diagnosed by psychiatrist
• DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode
• HamD-17 score ≥ 22

You may not qualify if:

• 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

Sponsors & Collaborators

• Affectis Pharmaceuticals AG: lead
• FGK Clinical Research GmbH: collaborator

Study Sites (25)

Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie

Klagenfurt, A-9020, Austria

Location

Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH

Salzburg, A-5020, Austria

Location

Faculty Hospital Brno

Brno, 639 00, Czechia

Location

Hospital Ceske Budejovice

České Budějovice, 370 87, Czechia

Location

Pardubice Regional Hospital

Pardubice, 532 03, Czechia

Location

1st Medical Faculty Prague

Prague, 120 00, Czechia

Location

Prague Psychiatric Centrum

Prague, 181 03, Czechia

Location

Masaryk Hospital

Ústí nad Labem, 401 13, Czechia

Location

Charite - Center for Psychiatry and Psychotherapy

Berlin, D-10117, Germany

Location

LWL-Universitätsklinik Bochum

Bochum, 44791, Germany

Location

University Bonn, Center for Psychiatry and Psychotherapy

Bonn, D-53105, Germany

Location

Klinik für Psychiatrie und Psychotherapie der Universität zu Köln

Cologne, 50924, Germany

Location

Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy

Dresden, D-01307, Germany

Location

Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy

Göttingen, D-37075, Germany

Location

Hospital Guenzburg, Center for Psychosomatic Medicine

Günzburg, D-89312, Germany

Location

University Jena, Center for Psychiatry and Psychotherapy

Jena, D-07743, Germany

Location

Fachklinik Katzenelnbogen

Limburg An Der Lahn (Katzenelnbogen), 56368, Germany

Location

Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine

Magdeburg, D-39120, Germany

Location

Klinikum der Johannes Gutenberg-Universität Mainz

Mainz, 55131, Germany

Location

Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie

Mannheim, 68159, Germany

Location

Ludwig-Maximilians University Munich

Munich, D-80336, Germany

Location

Max Planck Institute of Psychiatry

Munich, D-80804, Germany

Location

Center for Psychiatry and Psychotherapy, University of Muenster

Münster, D-48149, Germany

Location

Bezirksklinikum Regensburg

Regensburg, 93053, Germany

Location

Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy

Stralsund, D-18437, Germany

Location

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

cimicoxib

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Manfred Rüdiger

  Affectis Pharmaceuticals AG

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: October 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

DE (17); AU (2); CZ (6)