Clinical trial NCT01594866: Lexapro®'s Efficacy After Dose Escalation in Remission Study
Official title: A Double-blinded 6-week Prospective Study to Evaluate the Remission Rate According to Dose of Escitalopram (Lexapro®) in Patients With Major Depressive Disorder: a Preliminary Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major depressive disorder, remission, escitalopram
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: H. Lundbeck A/S
First posted: 2012-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and 30 mg in patients with major depressive disorder.

Detailed description: In this study, the investigators are going to examine the efficacy of escitalopram after dose escalation and evaluate remission rate. This study design is the double-blinded 6-week prospective study. It would be useful for clinicians because there were few study of high-dose antidepressant treatment in lack of remission in major depressive disorder patients. To control of bias, the investigators included patients with lack of remission after 4-week escitalopram treatment.

Eligibility criteria: Inclusion Criteria:

* Age: 18 \~ 65
* Patient with major depressive disorder according to DSM-IV criteria
* Patient have signed on the informed consent, and well understood the objective and procedure of this study.
* MADRS total score ≥ 18
* Competent patient who is manage to answer the questionnaires.
* In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.

Exclusion Criteria:

* In previous depressive episodes, no efficacy although more than one antidepressant treatment
* Allergy or hypersensitivity to escitalopram
* Diagnosed to schizophrenia or bipolar disorder or schizoaffective disorder (DSM-IV)
* MADRS 10 score ≥ 5, or patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
* Pregnant or breast-feeding female patient
* Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
* Significant severe medical condition
* Patients who take antipsychotics or mood stabilizer or other psychiatric drugs excluding benzodiazepines or beta blockers or hypnotics
* History of participating to other investigational drug trial within 1month prior to screening
* Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator

Primary outcomes:
measure: Montgomery-Åsberg Depression Rating Scale (MADRS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Hamilton Depression Rating Scale-17 items (HAM-D)
timeFrame: 6 weeks
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: 6 weeks
measure: Clinical Global Impression-severity (CGI-S)
timeFrame: 6 weeks
measure: Clinical Global Impression-Improvement (CGI-I)
timeFrame: 6 weeks
measure: Beck's Depression Inventory(BDI)
timeFrame: 6 weeks
measure: WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)
timeFrame: 6 weeks
measure: Clinically Useful Depression Outcome Scale (CUDOS)
timeFrame: 6 weeks
measure: Short From-36 Health survey (SF-36 Health survey)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yong Min Ahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: