Cimicoxib for the Treatment of Major Depression (SECIM)

November 12, 2013 updated by: Affectis Pharmaceuticals AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
169

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Placebo + Sertraline
Drug: Placebo
tablet
Other Names:
  • PLC
Experimental: Cimicoxib
Sertraline + Cimicoxib
Drug: Cimicoxib
50 mg per tablet, bid (total daily dose 100 mg)
Other Names:
  • AFX

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
• Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).
Time Frame: 6 Weeks
6 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
• 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
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Affectis Pharmaceuticals AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
FGK Clinical Research GmbH

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Manfred Rüdiger, Affectis Pharmaceuticals AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 2, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 13, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 12, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AFX-01
  • EudraCT-No. 2007-001335-54

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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