Major Depressive Disorder MedDRA version: 9.1 Level: LLT Classification code 10025453 Term: Major depressive disorder NOS
Conditions
Interventions
Trade Name: CIPRALEX 10 mg
Pharmaceutical Form: Coated tablet
CAS Number: 219861082
Other descriptive name: ESCITALOPRAM OXALATE
Concentration unit: mg milligram(s)
Concentration type: equal
Concentra
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 ICF. No study-related procedures may be performed before the patient has signed the form. 3. The patient has an MDE according to DSM-IV-TR criteria (classification code 296.XX). 4. The reported duration of the current MDE is at least 3 months. 5. The patient has a MADRS total score =30. 6. The patient is a man or woman, aged between 18 and 65 years (extremes included) 7. The patient, if female, must: a) agree not to try to become pregnant during the study, AND b) use adequate contraception (adequate contraception is defined as oral/systemic contraception, intrauterine device, diaphragm in combination with spermicide, or condom for male partner in combination with spermicide), OR c) have had her last natural menstruation at least 24 months prior to baseline, OR d) have been surgically sterilised prior to baseline, OR e) have had a hysterectomy prior to baseline, OR f) not be sexually active with men. 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 one or more of the following conditions: a) Any current psychiatric disorder other than MDD as defined in the DSM IV TR (assessed by the MINI). b) Current or past history of: 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 disorder (except nicotine and caffeine) within the previous 6 months as defined in the DSM-IV-TR. d) History of alcohol abuse or dependence within the previous 6 months as defined in the DSM-IV TR. e) Previous use of hallucinogenic drugs. f) Presence or history of a clinically significant neurological disorder (including epilepsy). g) Neurodegenerative disorder (Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, Huntington disease, etc.). h) Any Axis II disorder that might compromise the study. 2. The patient has a significant risk of suicide according to the investigator’s opinion or has a score =5 on item 10 (suicidal thoughts) of the MADRS or has made a suicide attempt in the previous 12 months. 3. The patient used/uses disallowed recent or concomitant medication (specified in Appendix 2) or it is anticipated that the patient will require treatment with at least one of the disallowed concomitant medications during the study. 4. The patient has received electroconvulsive therapy within 6 months prior to screening. 5. The patient is currently receiving formal cognitive or behavioural therapy, systematic psychotherapy, or plans to initiate such therapy during the study. 6. The patient has a clinically significant unstable illness, e.g. hepatic or renal insufficiency, or a cardiovascular, pulmonary, gastrointestinal, endocrine, neurological, infectious, neoplastic, or metabolic disturbance. 7. The patient has clinically significant abnormal vital signs. 8. The patient has a history of severe drug allergy or hypersensitivity, or known hypersensitivity to escitalopram. 9. The patient has one or more laboratory values outside the normal range, based on the blood or urine samples taken at the Screening Visit, that are considered by the investigator to be clinically significant. 10. The patient has a clinically significant abnormal ECG. 11. The patient has a disease or takes medication that, in the opinion of the investigator, could interfere with the assessments of safety, tolerability, or efficacy. 12. The patient has been treated with any investigational medicinal product within 30 days or 5 half lives (whichever is longer) prior to screening. 13. The patient is pregnant or breast-feeding. 14. The patient, in the opinion of the investigator, is unlikely to comply with the clinical study protocol or is unsuitable for any reason. 15. The patient is a member of the site personnel or their immediate families. 16. The patient has previously participated in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To compare the efficacy of escitalopram fixed dose 20 mg/day in combination with fixed doses of gaboxadol (5 and 10 mg/day) versus escitalopram fixed dose 20 mg/day after 8 weeks of treatment in patients with Major Depressive Disorder (MDD) as assessed by change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.;Secondary Objective: • evaluate the safety and tolerability of combination treatment during the study. • evaluate the proportion of patients who respond after 8 wks of treatment (response is defined as a =50% decrease in MADRS total score from baseline). • evaluate the proportion of patients who are in remission after 8 weeks of treatment (remission is defined as a MADRS total score =10). • evaluate the proportion of patients who respond at Weeks 1 and 2 (response is defined as a =50% decrease in MADRS total score from baseline). • compare the effect on sleep in patients with MDD as assessed by change in Insomnia Severity Index (ISI) total score. • compare the effect on anxiety symptoms in patients with MDD as assessed by the Hospital Anxiety and Depression scale (HAD). • compare the effect on disability in patients with MDD as assessed by change in Sheehan Disability Scale (SDS) subscores (work, social life and family life). ;Primary end point(s): Assessment of change from baseline in MADRS (Montgomery-Åsberg Depression Rating Scale) at Week 8. | — |
Countries
Austria
Outcome results
None listed