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DepressionPhase 2/3NCT00866593

A Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram in Depression

A Phase 2/3 study testing Generic Escitalopram and Innovator Escitalopram in people with Depression, run by Shanghai Mental Health Center at 6 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of this study is to evaluate the efficacy and safety of Generic Escitalopram in the treatment of Chinese patients with depression compared with Innovator Escitalopram(Lexapro®) by evaluating the change of HAMD-17 total score from the baseline to week 8. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression
What is being tested?
Generic Escitalopram and Innovator Escitalopram
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
6 sitesChina
Study dates
Mar 2009to Mar 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Outpatients
  • Patients who met DSM-IV criteria for major depressive disorder(MDD):a single major depressive episode or recurrent major depressive episode, without psychotic features, MDD is primary mental disorder
  • Age from 18-65 years old, male or female
  • HAMD-17 total score at least 20 at screening and baseline, and first item's score at least 2
  • CGI-S at least 4 at screening and baseline
  • Written informed consent provided by patient himself/herself

Who cannot join

  • Severe suicide attempt
  • Any unstable medical illness would affect study or increase patients' risk to participate this study, including disease of heart, lung, liver, kidney,cardiovascular system, eyes, nervous system, endocrine system, hematological system etc.
  • History of epilepsy(except children febrile seizure/convulsion)
  • Known history of high intraocular pressure or angle closure glaucoma
  • Psychoactive substance abuse or dependence within 1 year prior enrollment
  • Depressive episode due to other mental disorders or physical diseases
Show all 19Show fewer
  • Bipolar disorder, rapid cycling/circulation
  • Female patients during their pregnant and lactation period or childbearing potential during study
  • History of severe drug hypersensitivity
  • A significantly clinical abnormal value in ECG or lab results which would affect assessment for efficacy or safety decided by the investigator
  • ALT and AST values in the liver function test exceeding two times of the upper limits of normal values
  • Participation in another drug trial within 28 days prior enrollment into this study
  • Use of MAOI within 4 weeks prior to randomization
  • Duration of discontinuing other psychotropics is shorter than its 7 half life periods
  • Patients can not administrate drug according to medical order
  • HAMD total score decreased more than 25% from screening to baseline
  • Use of Electroconvulsive therapy within half year prior enrollment
  • Known lack of efficacy to escitalpram by formal treatment before
  • Other situation unsuitable to enroll in this study as judged by the investigator

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Hebei Mental Health Center

    Baoding, Hebei, 071000

  • The First Affilliated Hospital Of Kunming Medical College

    Kunming, Yunnan, 650032

  • Nanjing Brain Hospital

    Nanjing, Jiangsu, 210029

  • Shanghai Mental Health Center

    Shanghai, Shanghai Municipality, 200030

  • the First Affiliated Hospital，Medical School of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710061

  • Xi'an Mental Health Center

    Xi'an, Shaanxi, 710061

Other trials in China

About this study

Official title: A Randomized Double-blind Parallel Innovator-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Generic Escitalopram Oxalate Tablets in the Treatment of Chinese Patients With Depression

The primary objective of this study is to evaluate the efficacy and safety of Generic Escitalopram in the treatment of Chinese patients with depression compared with Innovator Escitalopram(Lexapro®) by evaluating the change of HAMD-17 total score from the baseline to week 8.

Read the detailed description

This is a double-blind, parallel assignment, randomized and innovator controlled study. The subjects investigated are outpatients with major depressive disorder(MDD)according to DSM-IV from the Chinese population. The screening phase lasts for 1 week. The eligible patients enter the next randomized treatment phase. The fixed dose(generic escitalopram 10mg/d or Innovator Escitalopram(Lexapro®) 10mg/d) duration is 2 week. After the first 2 weeks, according to CGI and investigator's assessment the patients are administrated 2 different dose, one is previous dose 10mg/d, the other is high dose 20mg/d. In this study, total duration lasts for 8 weeks.

The efficacy and safety of Innovator Escitalopram(Lexapro®) in the treatment of patients with MDD have been confirmed by multiple double blind studies. This study is designed to evaluate the efficacy and safety of genetic escitalopram in the treatment of Chinese patients with MDD. Therefore, the double blind and innovator control(Lexapro®) design should be selected for this study. The drug titration method and dose are within the range specified in the instruction and patients with MDD are tolerant to the drug in practical clinical treatment.

The purpose of MDD patient treatment is to improve the core symptoms, prevent suicide, alleviate the side reactions caused by the antidepressant, and recover the life functions of patients. Generally, the treatment in the acute phase lasts for 6 to 8 weeks. In this study, the treatment in the acute phase lasts for 8 weeks.

The rating scales used in this study are standard psychiatric rating scales with good validity and are widely used in the study of antidepressants and in the treatment of patients with MDD. The high inter-investigator reliability and repeated measurement reliability of these scales(HAMD,MADRS,HAMA) have been proved by multiple studies. The clinical global impression (CGI) is a simple but convenient global impression scale. It is applicable to any patients treated and studied by the psychiatric department. The VAS-PI(Visual Analog Scale-Pain Intensity) is used to evaluate the reduction in pain intensity,a common symptom of patients with MDD. It has good reliability and validity. The Sheehan Disability Scale (SDS) was developed to assess functional impairment in three inter-related domains; work/school, social and family life.

Conditions
Depression
Being tested
Generic Escitalopram, Innovator Escitalopram
Keywords
major depressive disorder(MDD), depression, antidepressant, escitalpram oxalate, generic, innovator, Lexapro, efficacy, safety, multicenter, double-blind, randomized, chinese, HAMD, MADRS, HAMA, VAS-PI, SDS, CGI
Medical subject headings
Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Generic EscitalopramDrug

    Also called Generic Escitalopram Oxalate Tablet

    10mg/d or 20mg/d

  • Innovator EscitalopramDrug

    Also called Lexapro®

    10mg/d or 20mg/d

Study groups in NCT00866593
Study groupRoleWhat they receive
1ExperimentalGeneric Escitalopram Oxalate Tablets
Receives: Drug: Generic Escitalopram
2Active comparatorInnovator Escitalopram(Lexapro®)
Receives: Drug: Innovator Escitalopram

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the change of HAMD-17 total score

    Measured: from the baseline to week 8

Secondary outcomes (5)

  1. the change of MADRS total score

    Measured: from the baseline to week 8

  2. the change of HAMA total score

    Measured: from the baseline to week 8

  3. the clinical global impression (CGI),including CGI-I and CGI-S

    Measured: from the baseline to week 8

  4. the change of VAS-PI

    Measured: from the baseline to Week 8

  5. the change of Sheehan Disability Scale(SDS)

    Measured: from the baseline to Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2010
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
260 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00866593
Sponsor's protocol ID
2004L04118
Other IDs
SMHC-101
Status last verified
Apr 2013
First submitted
18 Mar 2009
Last updated
4 Apr 2013
Results posted
No
Data monitoring committee
No

Publications

  • Yu Y, Li H, Wang B, Li K, Xu X, Shi J, Gao C, Tan Q. Efficacy and safety of generic escitalopram versus Lexapro in the treatment of major depression: a multicenter double-blinded randomized controlled trial. Shanghai Arch Psychiatry. 2013 Apr;25(2):107-15. doi: 10.3969/j.issn.1002-0829.2013.02.007.

    PubMed 24991142

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Generic Escitalopram and Innovator Escitalopram in people with Depression, run by Shanghai Mental Health Center at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the change of HAMD-17 total score (time frame: from the baseline to week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00866593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2013.

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