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

• Status: Completed
• Trial end date: 2011-11-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Xian-Janssen Pharmaceutical Ltd.
• Treatments: Citalopram; Dexetimide

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