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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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14 April 2020 |
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Main ID: |
EUCTR2008-002319-42-SE |
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Date of registration:
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02/09/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy - HMGD
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Scientific title:
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Comparison of Two Different Treatment Strategies in Patients with Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy - HMGD |
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Date of first enrolment:
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24/10/2008 |
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Target sample size:
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1160 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002319-42 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: early intervention strategy vs late intervention strategy
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Denmark
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France
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Greece
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Hungary
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Italy
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Netherlands
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Slovenia
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Spain
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
[1] Male or female outpatients of at least 18 years of age who meet criteria for MDD, single or recurrent episode according to the DSM-IV®-TR disease diagnostic criteria.
[2] Patients (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current AD treatment to escitalopram for this current MDD episode, at Visit 1.
[3] Must have a baseline score of =19 on the HAM-D17 at visit 1.
[4] Must have a baseline score of = 4 in the Clinical Global Impression- Severity (CGI-S) at visit 1.
[5] Have a level of understanding sufficient to provide ICD, and to communicate with the investigators and site personnel.
[6] Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
[7] Have any current primary Axis I disorder other than MDD
[8] Have a diagnosis of dementia, Alzheimer’s disease, or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
[9] Concomitant participation in other studies with investigational or marketed products.
[10] Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness
[11] Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit
[12] Are investigator site personnel directly affiliated with this study and/or their immediate families
[13] Are employed by Lilly or Boehringer Ingelheim (BI)
[14] Women of childbearing potential who are not using a medically accepted means of contraception. Women who are pregnant or breast-feeding may not participate in the study.
[15] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
[16] Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the patient’s baseline (visit 1) HAMD17 scores on item 3 suicide are ?3.
[17] Have been treated with a MAOI within 14 days prior to visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
[18] Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment
[19] Have any contraindication for the use of duloxetine or escitalopram based on Duloxetine and Escitalopram SPC.
[20] Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
[21] Have any previous diagnosis of psychotic disorders.
[22] Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine
[23] Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
[24] Have had ECT or Transcranial Magnetic Stimulation within the past year
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Major depressive disorder
MedDRA version: 9.1
Level: LLT
Classification code 10025453
Term: Major depressive disorder NOS
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Intervention(s)
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Trade Name: Cymbalta
Product Name: Duloxetine
Product Code: LY248686
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Product Name: Escitalopram
Pharmaceutical Form: Over encapsulated tablet
INN or Proposed INN: Escitalopram
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form of the placebo: Over encapsulated tablet
Route of administration of the placebo: Oral use
Trade Name: Cymbalta
Product Name: Duloxetine
Product Code: LY248686
Pharmaceutical Form: Gastro-resistant capsule, hard
INN or Proposed INN: DULOXETINE
CAS Number: 116539594
Current Sponsor code: LY248686
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 60-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: •To compare the efficacy of both intervention strategies as measured by time to:
oConfirmed response as defined by =50% reduction in baseline QIDS-SR oConfirmed remission as defined by a QIDS-SR score of =5 that is maintained for two consecutive visits
•To compare the efficacy throughout the study as measured by the CGI-S rating scale.
•To compare the improvement of painful symptoms as measured by the VAS score for overall pain severity.
•To identify clinical and demographic predictors of earlier time to response and remission as measured by the HAMD17
•To compare the functional improvement as measured by the SDS
•To compare the direct and indirect costs by collecting resource utilisation data
•To compare the quality of life changes as measured by the EQ-5D
•To compare the safety of early intervention strategy with delayed intervention strategy as measured by both unsolicited TEAE and SAEs
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Primary end point(s): Time to confirmed response is defined as the time from the day of study randomization (visit 2) to the date of first observation of confirmed response defined as a >or=50% baseline score reduction on the HAMD17 for two consecutive visits.
Time to confirmed remission is defined as the time from the day of study randomization (visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD17 of =7 for two consecutive visits.
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Main Objective: This study has two primary objectives:
(1) to test the hypothesis that time to confirmed response is shorter in the early intervention strategy vs. the delayed intervention strategy, among patients identified as suffering from MDD with a lack of improvement after 4 weeks of escitalopram treatment
(2) to test the hypothesis that time to confirmed remission will be shorter in the early compared with the delayed strategy.
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Secondary ID(s)
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F1J-EW-HMGD
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2008-002319-42-NL
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 23/09/2008
Contact:
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