Clinical trial comparing early medication change with treatment as usual in patients with Major Depressive Disorder-EMC

• Conditions: Major Depressive disorder (MDD); MedDRA version: 14.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: LLTClassification code 10053708Term: Major depressive disorder with melancholic featuresSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 14.1Level: LLTClassification code 10025463Term: Major depressive disorder, single episodeSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; MedDRA version: 14.1Level: LLTClassification code 10025453Term: Major depressive disorder NOSSystem Organ Class: 10037175 - Psychiatric disorders

• Registration Number: EUCTR2008-008280-96-DE
• Lead Sponsor: Department of Psychiatry and Psychotherapy, University of Mainz

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-14
• Last Update Posted: 5 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 940

Inclusion Criteria

• Major Depressive Disorder (MDD), first episode or recurrent, according to DSM-IV
• A HAMD17 score of =18 pts.
• Age between 18 and 65 years and age = 60 years at the time of the first depressive episode
• Ability of subject to understand character and individual consequences of clinical trial
• Signed and dated informed consent of the subject must be available before start of any specific trial procedures.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 940
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Acute risk of suicide needing an intervention not comprised by protocol treatment (e.g. electroconvulsive therapy)
• Patients with a lifetime DSM-IV diagnosis of dementia, schizophrenia, schizoaffective disorder, bipolar disorder
• Patients with a current DSM-IV diagnosis of posttraumatic stress disorder, obsessive-compulsive disorder, anxiety disorder, or eating disorder and the requirement of a treatment not comprised by protocol treatment.
• Patients with DSM-IV substance dependency requiring acute detoxification.
• Depression due to organic brain disorder, e.g. Multiple Sclerosis and Parkinson’s Disease
• Women who are pregnant, breastfeeding or planning to become pregnant during the trial
• Women who are not sterile by surgery or for more than two years postmenopausal or women with childbearing potential who not practicing a medically accepted contraception during trial (reliable contraception are systemic contraceptives (oral, implant, injection), diaphragm or condoms with spermicide, sexual abstinence)
• A clear history of non-response to an adequate treatment trial in the current major depressive episode to any protocol antidepressant
• Patients currently taking antidepressant medication, which has been started within the 2-4 weeks prior to study begin and a continuation of this antidepressant medication is clinically indicated
• Medical or psychological condition that contraindicates the use of an investigational drug
• History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
• Clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation. Such conditions may include gastrointestinal, cardiovascular, vascular disease (particularly brady- and tachyarrhythmia, QT interval prolongation, congenital long QT syndrome, Torsades de pointes, heart failure NYHA class IV, myocardial infarction), pulmonary/respiratory, hepatic impairment, renal, metabolic diseases (particularly hypokalaemia or hypomagnesaemia), endocrinological, neurological, immune-deficiency, hematopoietic disease, or malignancies as determined by medical history, physical examination, or laboratory tests.
• Participation in other clinical trials during the present clinical trial or within the last 6 months
• Medical or psychological condition that would not permit signing of informed consent

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the trial is to compare effectiveness of EMC with TAU in the treatment of Major Depressive disorder (MDD) in non-improvers on day 14 (level 1 of The EMC Trial).;Secondary Objective: The secondary objectives of the trial are:<br>• to compare speed of recovery from MDD between EMC and TAU in non-improvers on day 14 (level 1 of The EMC trial)<br>• to compare the side effect profile and safety of EMC and TAU in non-improvers on day 14 (level 1 of The EMC trial).<br>• To compare changes in quality of life under EMC and TAU in non-improvers on day 14 (level 1 of The EMC trial).<br>• to compare effectiveness, speed of recovery from MDD, changes in quality of life and side effect profile in subgroups of improvers on day 14 (levels 2 and 3 of The EMC trial)<br>;Primary end point(s): Remission from MDD, defined as a HAMD-17 sum score =7 on day 56;Timepoint(s) of evaluation of this end point: after 56 days

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Response, defined as a HAMD17 sum score decrease =50% on day 56<br>- Absolute change of HAMD17 sum score [day 56-day 0]<br>- Remission defined as IDS score = 11 on day 56<br>- Response defined as IDS score decrease =50% on day 56 <br>- Time to remission and time to response according to IDS and HAMD17<br>- Remission from MDD, defined as a HAMD17 sum score = 7 on day 56 (subgroups of improvers on day 14)<br>- Absolute change in SF12 subscales physical component score and mental component score [day 56-day 0]<br>- Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG;Timepoint(s) of evaluation of this end point: after 56 days