Major Depressive Disorder
Conditions
Sponsors
H. Lundbeck A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The patient is able to read and understand the Patient Information Sheet. 2. The patient has signed the Informed Consent Form. 3. The patient suffers from Major Depressive Disorder (current episode assessed with the MINI), diagnosed according to DSM-IV-TR criteria except with a prior duration of the current episode of at least 3 months and less than 2 years. 4. The patient has a CGI-S score =5 5. The patient has a MADRS total score at baseline =30. 6. The patient has a SDS score =5 on at least one item. 7. The patient is, in the opinion of the investigator, otherwise healthy on the basis of a physical examination, medical history, and vital signs. 8. The patient is an outpatient. 9. The patient is man or woman between 18 and 65 years of age, extremes inclusive. 10. Patient is willing and able to attend study appointments within the allowable time windows. 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
Exclusion criteria: 1. The patient has previously participated in this study. 2. The patient has made a suicide attempt in the past and has, in the investigator’s opinion, a significant risk of suicide and/or has a score greater than or equal to 5 on item 10 (suicidality) of the MADRS. 3. The patient uses disallowed recent or concomitant medication: a. oral antipsychotics and antimanic drugs (including lithium) within 2 weeks and depot preparations within 6 months prior to baseline. b.electroconvulsive treatment (ECT) within the last 6 months prior to baseline. c.monoamine oxidase inhibitors (MAOIs) and reversible monoamine oxidase A inhibitors (RIMAs) within the last 3 weeks prior to baseline. d.fluoxetine within the last 4 weeks prior to baseline. e.any other antidepressant (including SNRIs) within the last week prior to baseline. f.herbal remedies, which are psychoactive (for example, St. Johns Wort, kava kava, valerian, ginkgo biloba etc.) within the last 2 weeks prior to baseline. g.any drug used for augmentation of antidepressant action within the last 2 weeks prior to baseline with the exception of stable treatment of hyper thyroidism. h.psychotropic drugs within the last week prior to baseline, except zolpidem, zopiclone, and zaleplon, which can be prescribed episodically for insomnia (maximum 3 days in a row, and maximum 6 days in total during the study). i.tryptophan within the last 2 weeks prior to baseline. j.dopamine antagonists (for example, metoclopramide), for any indication, within the last 2 weeks prior to baseline. k.any anxiolytics (including benzodiazepines) within the last week prior to baseline. l.any anticonvulsant drug (for example, phenytoin, carbamazepine etc) within the last 2 weeks prior to baseline. m.serotonergic agonists (for example, triptans) within the last 2 weeks prior to baseline. n.narcotic analgesics (except intermittent use of codeine-based analgesics for headache etc.) within 2 weeks prior to baseline. 4. The patient has been treated with any investigational product within 3 months prior to baseline. 5. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram or citalopram. 6. The patient is currently receiving formal behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the trial. 7. The current depressive symptoms of the patient are considered by the investigator to have been resistant to 2 well-conducted, antidepressant treatments of at least 6 weeks duration. 8. The patient has been treated with escitalopram or citalopram within the current major depressive episode. 9. The patient has not responded to a previous treatment with escitalopram or citalopram. 10. The patient has one or more of the following conditions: a. any current psychiatric disorder established as the principal diagnosis other than MDD as defined in the DSM-IV-TR. b. current or past history of obsessive compulsive disorder, manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV-TR. c. any substance abuse disorder (except nicotine and caffeine) as defined in the DSM-IV-TR with the exception of this being within the previous 6 months. d. presence or history of a clinically significant neurological disorder (including epilepsy). e. neurodegenerative disorder
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1) To compare the efficacy of escitalopram (20mg/day) and citalopram (40mg/day) during the course of the trial 2) To evaluate the tolerability of escitalopram (20mg/day) and citalopram (40mg/day) during the course of the trial 3) To evaluate the proportion of patients on escitalopram or citalopram who are in remission at Week 8. Remission is defined as a MADRS score less than or equal to 12 4)To evaluate the proportion of patients who respond to escitalopram or citalopram treatment at Week 8 and their time to response. Response is defined as 50% decrease in MADRS total score from baseline ;Primary end point(s): Primary efficacy parameter will be MADRS total score. ;Main Objective: To compare the efficacy of escitalopram (20mg/day) with that of citalopram (40mg/day) at the end of 8 weeks treatment of outpatients with Major Depressive Disorder (MDD) | — |
Countries
Austria, Estonia, Hungary
Outcome results
None listed