Interventional, open-label study of flexible doses of vortioxetine on depressive symptoms in patients with major depressive disorder and early dementia - Memory

H. LUNDBECK A/S0 个研究点目标入组 100 人开始时间: 2020年10月7日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•The patient has a primary diagnosis of recurrent Major Depressive Disorder (MDD) with onset before age of 55, diagnosed according to DSM-5®
•The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).
•The patient has had the current MDE for <6 months.
•The patient has a Montgomery and Åsberg Depression Rating Scale (MADRS) total score =26 at the Baseline Visit.
•The diagnosis of onset of dementia has occurred at least 6 months prior to screening and after already being diagnosed with MDD. The diagnosis of dementia must be documented in patient's medical records. When deemed necessary per investigator judgement of patient clinical status and early dementia, the patient must be accompanied by a caregiver to study visits.
•Patients with dementia associated with vitamin B12 or folate deficiency should not be enrolled.
•Patients with or without treatment for dementia can be enrolled. For patients on treatment for dementia, there must be no change in treatment during the study and patients must be on stable dose for at least 3 months prior to the Screening Visit.
•The patient has Mini Mental State Examination (MMSE) total score 2024, inclusive.
•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 70
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 30

•The patient has any current psychiatric disorder or Axis I disorder (DSM-5® criteria), established as the primary diagnosis, other than MDD, as assessed using the Mini International Neuropsychiatric Interview (MINI) or another diagnostic interview.

发起方