Clinical trial NCT01814098: An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms
Official title: Escitalopram in the Long-term Treatment of Major Depressive Disorder With Associated Anxiety Symptom
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Keywords: Depressive Disorder, Major
Escitalopram
Lexapro
Lead sponsor: Xian-Janssen Pharmaceutical Ltd.
Sponsor class: INDUSTRY
First posted: 2013-03-19
Enrollment: 318
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Percentage of Participants With Remission According to Montgomery-Asbery Depression Rating Scale (MADRS) and Hamilton Anxiety Scale (HAM-A)
timeFrame: Week 24
Secondary outcomes:
measure: Percentage of Participants Showing Response
timeFrame: Week 24
measure: Change From Baseline in MADRS Total Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline of Single Rating Item in MADRS Total Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Hamilton Depression Rating Scale (HAMD)-17 Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Hamilton Anxiety Scale (HAM-A) Score at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline of Single Rating Item in HAM-A at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Clinical Global Impression Score (CGI-S) at Week 24
timeFrame: Baseline and Week 24
measure: Change From Baseline in Short Form-12 (SF-12) Score at Week 24
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
city: Beijng
country: China
city: Changsha
country: China
city: Hangzhou
country: China
city: Nanjing
country: China
city: Shanghai
country: China
city: Shenyang
country: China
city: Shijiazhuang
country: China
city: Tianjin
country: China
city: Wenzhou
country: China
city: Wuhan
country: China
Study officials:
affiliation: Xian-Janssen Pharmaceutical Ltd.
name: Xian-Janssen Pharmaceutical Ltd., China Clinical Trial
role: STUDY_DIRECTOR
References: