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Major Depressive Disorder | Lexapro®'s Efficacy After Dose Escalation in Remission Study

Major Depressive Disorder research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Major Depressive Disorder

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:escitalopramescitalopram 20mg and 30mg p.o. daily, 6 weeks

Drug:escitalopramescitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Escitalopram, 20mg, placeboescitalopram 20mg + placebo (same taste, appearance, texture of escitalopram 10mg)

Escitalopram 20mg, escitalopram 10mgEscitalopram 20mg + Escitalopram 10mg

Study Status

Unknown status

Start Date: May 2012

Completed Date: December 2016

Phase: Phase 4

Type: Interventional

Design:

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

Secondary Outcome: Hamilton Depression Rating Scale-17 items (HAM-D)

Study sponsors, principal investigator, and references

Principal Investigator: Yong Min Ahn, MD, PhD

Lead Sponsor: Seoul National University Hospital

Collaborator: H. Lundbeck A/S

More information:https://clinicaltrials.gov/show/NCT01594866

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