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An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms

Information source: Xian-Janssen Pharmaceutical Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Depressive Disorder, Major

Intervention: Escitalopram (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Xian-Janssen Pharmaceutical Ltd.

Official(s) and/or principal investigator(s):
Xian-Janssen Pharmaceutical Ltd., China Clinical Trial, Study Director, Affiliation: Xian-Janssen Pharmaceutical Ltd.

Summary

The purpose of this study is to evaluate the efficacy and safety of long term escitalopram treatment in participants with Major Depressive Disorder (MDD) with associated anxiety symptoms.

Clinical Details

Official title: Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of Participants With Remission According to Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A)

Secondary outcome:

Percentage of Participants Showing Response

Change From Baseline in MADRS Total Score at Week 24

Change From Baseline of Single Rating Item in MADRS Total Score at Week 24

Change From Baseline in Hamilton Depression Rating Scale (HAMD)-17 Score at Week 24

Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24

Change From Baseline of Single Rating Item in HAM-A at Week 24

Change From Baseline in Clinical Global Impression Score (CGI-S) at Week 24

Change From Baseline in Short Form-12 (SF-12) Score at Week 24

Detailed description: This is an open-label (all people know the identity of the intervention), single arm, prospective (study following participants forward in time), post-marketing, multi-center (when more than one hospital or medical school team work on a medical research study) study to evaluate the efficacy and safety of escitalopram in participants with MDD with associated anxiety symptoms. The duration of the study will be 24 weeks at a starting dose of escitalopram 10 milligram per day (mg/day). The dose will be flexibly adjusted (maximum 20 mg/day) after 2 weeks of treatment depending on Investigator's discretion. The study will consist of 9 visits: Baseline, Week 1, 2, 4, 8, 12, 16, 20 and 24. Assessments of efficacy and safety will be performed at each visit. The primary efficacy evaluation will be done by Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale(HAM-A). Participant's safety will also be monitored throughout the study.

Eligibility

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

Criteria:

Inclusion Criteria:

- Participant must be willing and able to give written informed consent

- Participant currently suffering from Major Depressive Disorder (MDD) with anxious

symptoms including participant with first MDD episode, and relapsed participant with new episode

- Participant with minimum score at baseline of 22 on the Montgomery-Asbery Depression

Rating Scale (MADRS) and minimum score at baseline of 14 on Hamilton Anxiety Rating (HAM-A) scales

- Female participant must be surgically sterile, or practicing an effective method of

birth control before entry and throughout the study Exclusion Criteria: Participant who has continuously taken psychoactive substances, antidepressants, anxiolytics, monoamine oxidase inhibitors (MAOIs), psychoactive herbal remedies, lithium, electroconvulsive therapy (ECT) carbamazepine in the past 2 weeks before the baseline

visit - Participants with MDD, requiring treatment systematically within past 2 months

from baseline - Participants who has contraindication to escitalopram - Participant has

primary or comorbid diagnoses of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self), schizoaffective disorder (a mixed psychiatric disorder relating to a complex psychotic state that has features of both schizophrenia and a mood disorder such as bipolar disorder), bipolar disorder, or dementia

(mental decline) - Participant who has a significant risk of suicide on clinical

assessment or has made a serious suicide attempt within the past 6-month

Locations and Contacts

Beijng, China

Changsha, China

Hangzhou, China

Nanjing, China

Shanghai, China

Shenyang, China

Shijiazhuang, China

Tianjin, China

Wenzhou, China

Wuhan, China

Additional Information

Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom

Starting date: July 2009
Last updated: May 30, 2014

Page last updated: August 23, 2015

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