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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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4 January 2022 |
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Main ID: |
EUCTR2004-002328-16-CZ |
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Date of registration:
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03/11/2004 |
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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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An eight-week, multicenter, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of one fixed 100 mg dose of Saredutant in patients with Major Depressive Disorder
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Scientific title:
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An eight-week, multicenter, double-blind, placebo-controlled study evaluating the efficacy, safety and tolerability of one fixed 100 mg dose of Saredutant in patients with Major Depressive Disorder |
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Date of first enrolment:
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21/03/2005 |
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Target sample size:
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450 |
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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:2004-002328-16 |
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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: yes
Placebo: yes
Other:
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Czech Republic
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Germany
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
- Male or female patients.
- 18 to 64 years of age.
- In patients or out patients.
- Written informed consent from the patient and/or legally authorized representative.
- Able to comply with the protocol and follow written and verbal instructions.
- Subjects of childbearing potential must have a confirmed negative serum beta-hCG prior to entry into Segment B and must employ an acceptable method of birth control at least on month prior to entry into Segment A, throughout the study, and at least one month after study completion.
- Diagnostic of major depressive disorder, as defined by DSMIV TR.
- Minimum total score of 22 on the MADRS.
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:
- Patients whose current depressive episode is diagnosed with psychotic features, catatonic features, seasonal pattern or post-partum onset.
- The duration of the current depressive episode is greater than 2 years.
- Patients having a current score of >5 on the suicidal thoughts item of the MADRS (item 10) and/or a score of 4 on the suicide item (item 3) of the Hamilton Depression Rating Scale at screening (V1, Day –7) or baseline (V2, Day –1) and/or endorses a Yes response (10 points) to items 4 (Have a suicide plan?) or 5 (Attempt suicide) of the C (suicidality) criteria of the MINI.
- History of a suicide attempt within 3 years prior to entry into Segment A.
- Patients whose current depressive episode is secondary to a general medical disorder (293.83).
- Patients with a history or presence or some other concomitant psychiatric disorders according to MINI criteria.
- Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months according to the MINI, except nicotine or caffeine dependence.
- Patients who have used the following prior to entry into Segment B : any antipsychotic within 3 months - fluoxetine within 35 days - any MAOI within 21 days - any other antidepressant, anxiolytic, sedative-hypnotic, or mood-stabilizer (lithium, anticonvulsants) within 7 days except permitted concomitant medications as defined in (Section 9.9.2).
- Patients who test positive for any illicit drug included in the urine drug screen Visit 1 (Day - 7).
- A 20% or greater decrease in MADRS total score during Segment A or a MADRS total score of<22 at entry into Segment B.
- Females who are pregnant or breast-feeding.
- Severe or unstable cardiovascular, renal, hepatic, respiratory, hematological, endocrinological, neurological, or other somatic disease that, according to the Investigator's judgment, might interfere with the evaluation of study medication.
- ECG abnormalities of potential clinical significance including a QT interval with Bazett's correction (QTcB) > or equal to 500msec at entry into Segment B.
- Use of known inducers or potent inhibitors of CYP3A4 within 7 days of entry into Segment B. These medications should be discontinued at entry into Segment A. See (Appendix 1) for a list of CYP3A4 inhibitors and inducers. Note that phenobarbital should be washed out for at least 30 days prior to entry into Segment B.
- Use of drugs with known risk for Torsade de Pointes within 7 days of entry into Segment B. All medications listed (Appendix 2) should be discontinued at entry into Segment A and washed out for the full 7 days of Segment A.
- Patients not compliant in taking study medication during Segment A (e.g., takes less than 80% of the prescribed number of capsules).
- Patients with a positive HbsAg or anti-HCV antibody test at screening (V1, Day –7).
- Patients with any of the following at screening (V1, Day –7):
ALT >2 times the upper limit of the normal range
AST >2 times the upper limit of the normal range
GGT >3 times the upper limit of the normal range
total or conjugated bilirubin above the upper limit of the normal range
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
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Intervention(s)
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Product Code: SR48968C
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: saredutant (succinate)
CAS Number: 176381-98-9
Current Sponsor code: SR48968C
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
Trade Name: DEROXAT
Product Name: paroxetine
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: paroxetine
Concentration unit: mg/g milligram(s)/gram
Concentration type: equal
Concentration number: 20-
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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Main Objective: To evaluate the efficacy of a 100 mg fixed dose of saredutant compared to placebo in patients with major depressive disorder
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Secondary Objective: To evaluate the tolerability and safety of saredutant in patients with major depressive disorder.
To evaluate the efficacy of saredutant compared to placebo on disability and quality of life in patients with major depressive disorder.
To evaluate plasma concentrations of saredutant and SR49596 and explore their relationships to efficacy and safety outcomes.
To evaluate the safety and tolerability of forty-four weeks of additional treatment with saredutant in patients completing the initial eight-week treatment period.
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Primary end point(s): Change from baseline to Day 56 in the 17-item Hamilton Depression Rating Scale (HAM-D) total score.
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 21/03/2005
Contact:
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