| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Major Depressive Disorder |
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| MedDRA Classification |
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| To compare the efficacy of escitalopram with that of duloxetine in outpatients with Major Depressive Disorder (MDD) after 24 weeks of treatment. |
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| E.2.2 | Secondary objectives of the trial |
To compare the efficacy of escitalopram with that of duloxetine per visit over the 24-week study period in outpatients with MDD.
To compare the tolerability and safety of escitalopram with that of duloxetine over the 24-week study period in outpatients with MDD.
To evaluate the discontinuation emergent signs and symptoms during and after taper-down treatment with escitalopram or duloxetine after 24 weeks of treatment.
To evaluate the impact of treatment with escitalopram or duloxetine on the quality of life in patients with MDD.
To evaluate the utilization of resources in patients with MDD treated with escitalopram or duloxetine.
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| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal inclusion criteria |
1.The patient is able to read and understand the Patient Information Sheet.
2.The patient has signed the Informed Consent Form. No study-related procedures may be performed before the patient has signed the form.
3.The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR criteria (classification code 296.xx) (current episode assessed with the MINI23,24).
4.The patient is an outpatient, male or female.
5.The patient is aged > or equal 18 < or equal 65 years.
6.The patient has a MADRS total score > OR EQUAL 26 at the baseline visit.
7.The patient has a CGI-S score >or equal 4 at the baseline visit.
8.The patient, in the opinion of the investigator, is otherwise healthy on the basis of a physical examination, medical history and vital signs.
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| E.4 | Principal exclusion criteria |
1.The patient has previously participated in this study.
2.The patient has a significant risk of suicide according to investigator’s opinion or presents a score > or equal 5 on item 10 (suicidal thoughts) of the MADRS.
3.The patient meets DSM-IV-TR criteria (as assessed with the MINI) for:
-current Obsessive-Compulsive Disorder,
-current Post-traumatic Stress Disorder,
-current Panic Disorder,
-past or current manic or hypomanic episode,
-past or current psychotic symptoms or disorder,
-current drug or alcohol abuse or dependence,
-current eating disorder (anorexia or bulimia).
4.The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR.
5.The patient presents a personality disorder that might compromise the study.
6.The patient has increased intra-ocular pressure or is at risk of acute narrow-angle glaucoma.
7.The patient has a serious illness and/or serious sequelae thereof, including liver or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological (including epilepsy), infectious, neoplastic, or metabolic disturbance. (If there is a history of such disease but the condition has been stable for at least one year and is judged by the investigator not to render inclusion unsafe and not to interfere with the patient’s participation in the study, the patient may be included).
8.The patient uses the following disallowed recent or concomitant medication within the specified time periods:
a.any antidepressant within the last week (5 weeks for fluoxetine, 2 weeks for fluvoxamine) prior to baseline.
b.monoamine oxidase inhibitors (MAOIs) or reversible monoamine oxidase A inhibitors (RIMAs) within 2 weeks prior to baseline.
c.any drug used for augmentation of antidepressant action within the last week prior to baseline.
d.any anxiolytics (including benzodiazepines) within the last week prior to baseline.
e.any hypnotics within the last week prior to baseline, except zolpidem, zopiclone or zaleplon which can be prescribed episodically for insomnia.
f.oral antipsychotics within 2 weeks or depot antipsychotics within 6 months prior to baseline.
g.serotonergic medicinal products (for example, triptans, tryptophan, tramadol) within the last week prior to baseline.
h.lithium, valproate or valpromide or other mood stabilisers within 2 weeks prior to baseline.
i.electroconvulsive therapy within 6 months prior to baseline.
j.dopamine antagonists (for example, metoclopramide), for any indication, within the last week prior to baseline.
k.herbal remedies, which are psychoactive (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba) within the last week prior to baseline.
l.any other drug with potential psychotropic effects within the last week prior to baseline.
m.any anticonvulsant drug within the last 2 weeks prior to baseline.
n.anticoagulants and/or medicinal products known to affect platelet function within the last 2 weeks prior to baseline.
o.potent inhibitors of CYP2C19 (for example, omeprazole) within the last 2 weeks prior to baseline.
p.potent inhibitors of CYP1A2 (for example, fluvoxamine, ciprofloxacin and enoxacine) within the last 2 weeks prior to baseline.
q.cimetidine within the last week prior to baseline.
r.medicinal products that are predominantly metabolised by CYP2D6 if they have a narrow therapeutic index (for example, flecainide and propafenone) within the last 2 weeks prior to baseline.
s.medicinal products containing duloxetine within the last week prior to baseline.
t.any investigational product within 3 months prior to baseline.
9.The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study.
10.The current depressive symptoms of the patient are considered by the investigator to have been resistant to two well-conducted antidepressant treatments of at least 6 weeks duration.
11.The patient has demonstrated a lack of response to previous treatment with citalopram, escitalopram, or duloxetine (including current episode).
12.The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to citalopram, escitalopram, or duloxetine.
13.The patient has hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase insufficiency.
14.The patient is pregnant or breast-feeding.
15.The patient, if a woman of childbearing potential, is not using adequate contraception (adequate contraception is defined as oral/systemic contraception, surgical sterilisation, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide).
16.The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The primary efficacy endpoint is the change from baseline in MADRS total score at end of Week 24. |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | Yes |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
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| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | |
| E.8.9.1 | In the Member State concerned months | 11 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 11 |
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