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Lexapro�'s Efficacy After Dose Escalation in Remission Study

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Major Depressive Disorder

Intervention: escitalopram (Drug); escitalopram (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Yong Min Ahn, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital

Overall contact:
Eun Young Kim, MD, Phone: 82 2 2072 2457, Email: npeunyoung@gmail.com

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Montgomery-Åsberg Depression Rating Scale (MADRS)

Secondary outcome:

Hamilton Depression Rating Scale-17 items (HAM-D)

Hamilton Anxiety Rating Scale (HAM-A)

Clinical Global Impression-severity (CGI-S)

Clinical Global Impression-Improvement (CGI-I)

Beck's Depression Inventory(BDI)

WHO Quality Of Life scale Abbreviated Version(WHOQOL-BREF)

Clinically Useful Depression Outcome Scale (CUDOS)

Short From-36 Health survey (SF-36 Health survey)

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Eun Young Kim, MD, Phone: 82 2 2072 2457, Email: npeunyoung@gmail.com

Seoul National University Hospital, Seoul, Korea, Republic of; Recruiting
Yong Min Ahn, MD, PhD, Principal Investigator
Additional Information

Starting date: May 2012
Last updated: December 5, 2013

Page last updated: August 23, 2015

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