major depression MedDRA version: 9.1 Level: LLT Classification code 10057840 Term: Major depression
Conditions
Interventions
Trade Name: Sertralin
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Sertralin
CAS Number: 79559-97-0
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Affectis Pharmaceuticals AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Major depression diagnosed by psychiatrist 2. DSM IV TR: 296.2x single depressive episode or 296.3x recurrent depressive episode 3. HamD-17 score = 22 4. Informed consent 5. Age between 18 and 60 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Psychotic depression or bipolar disorder, obsessive compulsive disorder, anxiety disorder, personality disorder, drug or alcohol abuse, schizoaffective disorders, schizophrenia 2. All DSM IV TR Axis-I disorders except depression 3. All DSM IV TR Axis-II disorders without exception 4. Unsuccessful treatment with more than 2 antidepressant medications (at therapeutically adequate doses and duration) 5. Concomitant use of psychotropic drugs, including mood stabilizers 6. Immediate risk for suicidal behaviour (3 on HamD-17 rating scale or 5 on MAD Rating Scale) 7. Women who are pregnant, breast feeding or planning to become pregnant during the course of study 8. Women who are not post-menopausal (no natural menopause established in retrospect after 12 consecutive months of amenorrhoea without hormone replacement therapy during the last 5 months), surgically sterilized or using a highly effective method of contraception (an implanted or injected hormonal contraceptive, some intrauterine contraceptive devices (IUDs) containing hormones, sexual abstinence, or have a vasectomised partner). Females using combined oral contraceptives should use a different or additional highly effective method of contraception as listed above. 9. 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 10. Patients at risk of QT/QTc interval prolongation (QTC> 450 ms, family history of long QT syndrome or use of medication prolonging QT/QTc interval) 11. History of coronary heart disease (CHD) or any other heart disease 12. Serum NTproBNP = 125 pg/ml indicating (sub-)clinical heart failure 13. History of upper or lower gastrointestinal (GI) ulceration, perforation and/or obstruction 14. History of upper or lower GI bleeding within the previous year 15. History of inflammatory bowel disease 16. Undergoing cancer chemotherapy 17. Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), liver function tests (AST, ALT) > 2x ULN, diabetes, asthma, COPD, Parkinson’s or Alzheimer’s disease, or any other serious condition likely to interfere with the conduct of the trial 18. Clinically relevant hepatic or renal impairment, or other clinically significant physical findings or clinically significant laboratory results at screening or baseline, as determined by the investigator 19. History of allergy to sertraline, cimicoxib or closely related compounds or excipients 20. History of hypersensitivity or intolerance to pain medications 21. Currently taking a monoamine oxidase inhibitor (MAOI) or within 14 days of discontinuing treatment with an MAOI 22. Currently taking pimozide 23. Currently taking fluoxetin 24. Use of pain medication, such as a COX-2 inhibitor, NSAID (non-steroidal anti-inflammatory drug, including aspirin) or acetaminophen (paracetamol) within 72 hours prior to study entry (24 hours for short-acting drugs such as aspirin or acetaminophen) 25. Currently taking sucralfate or misoprostol 26. Participation in a study of an investigational drug or device concomitantly or within 30 days prior to this study 27. Patients thought to be unreliable or incapable of complying with the requirements of the protocol 28. Positive drug test (except for benzodiazipine) 29. Patient is relative of, or staff directly report
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the mean change on the total score of the Hamilton Depression Rating Scale (HamD-17) items from baseline to endpoint (Week 6). The main objective of this study is to evaluate whether patients treated with sertraline and cimicoxib have a higher mean HamD-17 change than patients treated with sertraline and placebo.;Secondary Objective: • 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. Response will be defined as a decrease from baseline in total HamD-17 score of at least 50%. Remission will be defined as a total HamD-17 score of less than 7 • Onset of action, i.e. percentage of patients with a reduction from baseline in HamD-17 score of at least 20% within 2 weeks • Use of concomitant benzodiazepines • Sertralin dose increase after 3 weeks ;Primary end point(s): Efficacy will be assessed according to guideline CPMP/EWP/518/97 Rev 1 (Note for guidance on clinical investigation of medicinal products in treatment of depression) using the HamD-17 rating scale for depression. The investigators will be trained in the use of these rating scales. Determination of the response rate (i.e. proportion of patients with > 50% improvement of HamD 17), are also consistent with the requirements of the CPMP guideline. The safety assessments include standard parameters (adverse events, clinical laboratory tests, 12-lead ECGs and vital signs) as well as additional cardiovascular safety assessment (at screening) in view of the known class effects of COX-2 inhibitors and the finding in non-clinical studies with cimicoxib. Therefore patients with coronary heart disease (CHD) or any other heart disease will be excluded from the study. | — |
Countries
Austria, Czech Republic, Germany
Outcome results
None listed