Randomised Clinical Trial Comparing Early Medication Change (EMC) Strategy With Treatment as Usual (TAU) in Patients With Major Depressive Disorder - the EMC Trial

K. Lieb1 site in 1 country889 target enrollmentSeptember 2009

ConditionsDepression

InterventionsEscitalopram, venlafaxine, lithium Escitalopram, venlafaxine

DrugsEscitalopram, venlafaxine, lithium Escitalopram, venlafaxine

Overview

Phase: Phase 4
Intervention: Escitalopram, venlafaxine, lithium
Conditions: Depression
Sponsor: K. Lieb
Enrollment: 889
Locations: 1
Primary Endpoint: Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192)
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The EMC trial investigates for the first time prospectively whether Major Depression Disorder patients with non-improvement after 14 days of antidepressive treatment with EMC are more likely to become remitters compared to patients treated according to current guidelines, i.e., with a medication change after 28 days of treatment in case of non-response.

Registry

clinicaltrials.gov

Start Date

September 2009

End Date

May 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

K. Lieb

Responsible Party

Sponsor Investigator

Principal Investigator

K. Lieb

Study Principal Investigator

Johannes Gutenberg University Mainz

Eligibility Criteria

Inclusion Criteria

•Major Depressive Disorder (MDD), first episode or recurrent, according to DSM-IV
•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.

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
•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
•A clear history of non-response to an adequate treatment trial in the current major depressive episode to any protocol antidepressant. A "clear history of non-response" has to be assumed, when the following criteria are fulfilled:
•ad Escitalopram: Treatment with a mDDD ≥ 15 mg/d for 4 weeks or CPL 15-80 ng/ml for four weeks without response, i.e. a symptom reduction ≥ 50% between start and end of treatment.

Arms & Interventions

EMC (Early Medication Change)

Intervention: Escitalopram, venlafaxine, lithium

TAU (Therapy As Usual)

Intervention: Escitalopram, venlafaxine

Outcomes

Primary Outcomes

Remission from MDD on day 56, defined as a HAMD17 sum score ≤ 7, in non-improvers on day 14 (n=192)

Time Frame: 8 weeks

Secondary Outcomes

Absolute change in SF12 subscales "physical component score" and "mental component score"(8 weeks)
Absolute change of HAMD17 sum score(8 weeks)
Remission defined as IDS score ≤ 11 on day 56(8 weeks)
Time to remission and time to response according to IDS and HAMD17(8 weeks)
Occurrence of adverse events, UKU ratings at all visits, relevant laboratory data and deviations from normal ECG(8 weeks)
Remission from MDD, defined as a HAMD17 sum score ≤ 7 on day 56 (subgroups of improvers on day 14)(8 weeks)
Response, defined as a HAMD17 sum score decrease ≥50% on day 56(8 weeks)
Response defined as IDS score decrease ≥50% on day 56(8 weeks)