Major DepressionPhase 2NCT00510822
Cimicoxib for the Treatment of Major Depression (SECIM)
A Phase 2 study testing Cimicoxib in people with Major Depression, run by Affectis Pharmaceuticals AG at 25 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depression
- What is being tested?
- Cimicoxib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 169 participants
- Where
- 25 sitesin 3 countries
- Study dates
- Oct 2007to Feb 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Major depression diagnosed by psychiatrist
- DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode
- HamD-17 score ≥ 22
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
25 sites in 3 countries.
25 sites in 3 countries
Germany17 sites
Charite - Center for Psychiatry and Psychotherapy
Berlin, D-10117
LWL-Universitätsklinik Bochum
Bochum, 44791
University Bonn, Center for Psychiatry and Psychotherapy
Bonn, D-53105
Klinik für Psychiatrie und Psychotherapie der Universität zu Köln
Cologne, 50924
Carl Gustav Carus University Dresden, Center for Psychiatry and Psychotherapy
Dresden, D-01307
Georg-August-University Goettingen, Department of Psychiatry and Psychotherapy
Göttingen, D-37075
Hospital Guenzburg, Center for Psychosomatic Medicine
Günzburg, D-89312
University Jena, Center for Psychiatry and Psychotherapy
Jena, D-07743
Fachklinik Katzenelnbogen
Limburg An Der Lahn (Katzenelnbogen), 56368
Otto-von-Guericke University Magdeburg, Department of Psychiatry, Psychotherapy and Psychosomatic Medicine
Magdeburg, D-39120
Klinikum der Johannes Gutenberg-Universität Mainz
Mainz, 55131
Zentralinstitut für Seelische Gesundheit, Klinik für Psychiatrie und Psychotherapie
Mannheim, 68159
Ludwig-Maximilians University Munich
Munich, D-80336
Max Planck Institute of Psychiatry
Munich, D-80804
Center for Psychiatry and Psychotherapy, University of Muenster
Münster, D-48149
Bezirksklinikum Regensburg
Regensburg, 93053
Ernst Moritz Arndt University of Greifswald, Center for Psychiatry and Psychotherapy
Stralsund, D-18437
Czechia6 sites
Faculty Hospital Brno
Brno, 639 00
Hospital Ceske Budejovice
České Budějovice, 370 87
Pardubice Regional Hospital
Pardubice, 532 03
1st Medical Faculty Prague
Prague, 120 00
Prague Psychiatric Centrum
Prague, 181 03
Masaryk Hospital
Ústí nad Labem, 401 13
Austria2 sites
Landeskrankenhaus Klagenfurt, Abteilung für Psychiatrie und Psychotherapie
Klagenfurt, A-9020
Gemeinnützige Salzburger Landeskliniken Betriebsgesellschaft mbH
Salzburg, A-5020
About this study
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
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.
Read the 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).
- Conditions
- Major Depression
- Being tested
- Cimicoxib, Placebo
- Keywords
- Cimicoxib, Cox-2 inhibitor, Sertraline
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CimicoxibDrug
Also called AFX
50 mg per tablet, bid (total daily dose 100 mg)
PlaceboDrug
Also called PLC
tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo + Sertraline Receives: Drug: Placebo |
| Cimicoxib | Experimental | Sertraline + Cimicoxib Receives: Drug: Cimicoxib |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).
Measured: 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
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 169 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affectis Pharmaceuticals AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Responsible party
- Sponsor
- Investigators
- Manfred Rüdiger, Study director, Affectis Pharmaceuticals AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510822
- Sponsor's protocol ID
- AFX-01
- Other IDs
- EudraCT-No. 2007-001335-54
- Status last verified
- Nov 2013
- First submitted
- 1 Aug 2007
- Last updated
- 13 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00510822
- Acronym / sponsor ID
- AFX-01
- Conditions
- Major Depression
- Keywords
- Cimicoxib, Cox-2 inhibitor, Sertraline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 169 participants (actual)
- Lead sponsor
- Affectis Pharmaceuticals AGIndustry (pharma, biotech, devices)
- Collaborators
- FGK Clinical Research GmbH
- Study start
- Oct 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo + Sertraline |
| Cimicoxib | Experimental | Drug: CimicoxibSertraline + Cimicoxib |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Major depression diagnosed by psychiatrist
- DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode
- HamD-17 score ≥ 22
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CimicoxibAlso: AFX50 mg per tablet, bid (total daily dose 100 mg) | Drug | Cimicoxib |
| PlaceboAlso: PLCtablet | Drug | Placebo |
Primary outcome
• Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6).
Time frame: 6 Weeks
1 secondary outcome
• 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2013.
Related trials for Major Depression
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
RecruitingPhase 4
Biomarker-Guided Antidepressant Selection
Depression - Major Depressive Disorder, Treatment-resistant Depression (TRD)
Recruiting
Targeting Network Dysfunction in Apathy of Late-life Depression Using Digital Therapeutics
Major Depressive Disorder, Apathy
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
Acute Intermittent Hypoxia Therapy for Depression
Major Depressive Disorder (MDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Manfred Rüdiger study director
Affectis Pharmaceuticals AG
25 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cimicoxib in people with Major Depression, run by Affectis Pharmaceuticals AG at 25 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, Czechia, Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) from baseline to endpoint (Week 6). (time frame: 6 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2013.