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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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9 October 2012 |
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Main ID: |
EUCTR2006-002404-34-FI |
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Date of registration:
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30/08/2006 |
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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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Scientific title:
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A DOUBLE BLIND, MULTINATIONAL, MULTICENTRE, PLACEBO-CONTROLLED 10-WEEK STUDY ASSESSING THE EFFICACY AND SAFETY OF F2695 SR FLEXIBLE DOSE (75,100 MG /DAY) IN THE TREATMENT OF PATIENTS WITH MAJOR DEPRESSIVE DISORDER
EFFICACY AND TOLERANCE OF F2695 SR IN MAJOR DEPRESSIVE DISORDER
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Date of first enrolment:
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11/12/2006 |
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Target sample size:
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534 |
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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:2006-002404-34 |
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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: yes
Other: no
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Phase:
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Countries of recruitment
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Czech Republic
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Estonia
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Finland
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Germany
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Latvia
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Lithuania
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Sweden
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
male or female aged 18-70 years, Female of child bearing potential using a medically accepted method of contraception for at least 2 months before inclusion in the study or documented sterility or post-menopause (1 year amenorrhoea), out patient, meeting DSM-IV-TR criteria for Major Depressive Episode diagnosed using a structured interview (MINI), moderate or severe, unipolar, without psychotic features, Duration of current episode: at least 1 month, with a HAM-D17 total score > 22 at selection and inclusion visits, with a Sheehan Disability Scale total score > or = 10 and with at least one score > or = 6 on one of the subscales at selection and inclusion visits, ithout any clinically relevant abnormalities in clinical examination, laboratory tests and ECG parameters
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) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Patient at significant risk of suicide as assessed with the MINI§ Resistance to two well-conducted antidepressant treatments (defined by a lack of response to at least 2 treatments prescribed at their effective dose and during at least 4 weeks ) for the current episode, Any history of bipolar disorder, psychotic episode or disorder, Any current Panic disorder, Agoraphobia, Social phobia, Obsessive compulsive disorder, Generalized anxiety or Post Traumatic Stress Disorder, when the onset preceded the onset of the depressive episoden, Current major personality disorder of clinical significance, History of alcohol or drug abuse according to DSM IV criteria within the 6 months preceding selection, Fibromyalgia Syndrome, Chronic Fatigue Syndrome, Severe underlying or ongoing systemic disease, Previous history of generalized or partial seizure, Cardiovascular disease including myocardial infarction, cardiac failure, uncontrolled arterial hypertension, Known cardiac rhythm or conduction disorder, Known prostatic disorder and/or dysuria, Known acute glaucoma, Hepatic insufficiency, Stroke or any organic cerebral disease, Pregnancy or breast-feeding, ECG: QT or QTc greater than the upper limit of the normal range, Non-response to milnacipran for a previous episode
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: 8.1
Level: LLT
Classification code 10025453
Term: Major depressive disorder NOS
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Intervention(s)
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Product Name: F2695
Product Code: F2695SR
Pharmaceutical Form: Prolonged-release capsule, hard
Pharmaceutical form of the placebo: Prolonged-release capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Secondary Objective: -To assess the efficacy of F2695 SR flexible dose (75, 100 mg /day) versus placebo through the assessment of CGI improvement, Sheehan Disability Scale, HAM-D17 and COVI scale after 10 weeks of treatment,
- To assess the efficacy of F2695 SR flexible dose (75, 100 mg/day) versus placebo on somatic complaints through the assessment of Visual Analog Scales after 10 weeks of treatment.
-To assess the safety of F2695 SR flexible dose (75, 100 mg /day) versus placebo.
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Main Objective: To study the clinical efficacy of F2695 SR flexible dose (75, 100 mg /day) compared to placebo in patients with MDD through the assessment of MADRS after 10 weeks of treatment.
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Primary end point(s): Change in MADRS total score from baseline to Day 70.
Main efficacy analysis: MMRM (likelihood-based Mixed-effects Model Repeated Measures) analysis on MADRS total score changes from baseline over time with Treatment, Centre, Visit as categorical fixed factors, MADRS total score baseline as covariate, and, treatment-by-visit and baseline-by-visit interactions on the Full Analysis Set. Appropriate contrasts on treatment factor and treatment-by-visit interaction to estimate the difference between treatment group in mean change from baseline to D70.
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Secondary ID(s)
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2006-002404-34-EE
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F02695 LP 202
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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