Recovery Training of Emotion and Cognition with Vortioxetine for Depression (RECOVER-D) Study
- Conditions
- DepressionMental Health - Depression
- Registration Number
- ACTRN12622000610730
- Lead Sponsor
- Royal Melbourne Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
•Capacity to provide informed consent.
•Aged between 50 – 75 years of age.
•Able to see and hear, with or without sensory aids (e.g. glasses or hearing aids).
•Has adequate English skills to participate.
•Able to read and write.
•Has a Medicare card and a regular General Practitioner.
•Consents to the study team contacting their General Practitioner.
•Consent to take Vortioxetine during the study.
•Participants must not currently be taking anti-depressant medication.
•Current moderate depressive symptoms as confirmed by the Mini International Neuropsychiatric Interview (MINI).
•Depression symptom severity demonstrated as clinically significant (scores equaling or greater than 15) according to the Structured Interview Guide of the Hamilton Anxiety and Depression Scale (SIGH-AD).
•Depression symptom severity demonstrated as mild-moderate (16-19), or moderate (20-35) according the Montgomery Asberg Depression Rating Scale (MADRS) (Svanborg & Asberg, 2001).
•Reported duration of the current major depressive episode is at least 3 months.
•Participant has either been told or self-reports they are currently experiencing depressive symptoms.
•Participants must be willing and able to complete digital treatment tasks presented on a computer.
•Participants must have access to the internet and a computer/laptop in a private space.
•Study participant is willing to give blood samples during the study (at screening and week 2,as well as following any Vortioxetine dosage changes).
•Living in residential aged care (e.g. hostel or nursing home).
•Current alcohol and/or substance use disorder (DSM-5).
•Presence of a co-morbid psychiatric disorder other than mild to moderate depression that is a focus of clinical concern as confirmed by the MINI (e.g. schizophrenia or bipolar disorder).
•Depression symptom severity demonstrated as severe (36-60) according the Montgomery Asberg Depression Rating Scale (MADRS).
•People currently on antidepressant medication (except for Vortioxetine).
•People who are pregnant, trying to get pregnant or breast-feeding.
•People with active suicidality or a history of suicide attempt(s) within the past 2 years.
•Brain injury, neurological condition or impairment which could affect cognitive function (e.g. neurodevelopmental disorders, neurodegenerative disease, dementia).
•People currently taking medications approved for and/or employed off-label for cognitive dysfunction (e.g. psychostimulants).
•People currently taking any medication for a general medical disorder that in the opinion of the investigator may affect cognitive function (e.g. corticosteroids, beta-blockers).
•People currently on regular prescribed (i.e. not as needed” or PRN) antipsychotic or benzodiazepine medication.
•People currently participating in a research drug trial.
•Physical, cognitive or language impairment(s) of some severity as to adversely affect data derived from the THINC-It tool.
•People who have received electroconvulsive therapy within the last 6 months (they may be invited to call back when 6 months have elapsed).
•A history of unsuccessful Vortioxetine use and known allergies to Vortioxetine.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method