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Clinical Trials/ACTRN12622000610730
ACTRN12622000610730
Recruiting
未知

Evaluating the feasibility and acceptability of a combined treatment for depression using a personalised psychosocial intervention and Vortioxetine in older adults.

Royal Melbourne Hospital0 sites40 target enrollmentApril 22, 2022

Overview

Phase
未知
Intervention
Not specified
Conditions
Depression
Sponsor
Royal Melbourne Hospital
Enrollment
40
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 22, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • 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).

Exclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Not specified

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