Current Trials

F00222 Cognitive Impairment in Depression Trial

 McIntrye Medical Centre

Cognitive symptoms associated with Major Depressive Disorder (MDD) are estimated to occur in approximately two thirds of those affected and can include memory impairment, difficulty making decisions, and loss of cognitive flexibility.

We are actively seeking patients with a MDD diagnosis who are experiencing cognitive impairment to participate in a trial of a potential treatment of these cognitive symptoms.

Thinking2

Eligibility requirements

  • Age: 18-70
  • Sex:
  • BMI: 17.5-38
  • Medication: Inclusion Criteria: – Taking a stable dose of a first-line or second-line antidepressant approved for the treatment of depression (excluding TCAs, MAOIs & vortioxetine) Exclusion Criteria: – Type I or Type II diabetes requiring insulin – Treatment with stimulant drugs for ADHD – Regular use of benzodiazepines or similar sedative drugs in the daytime. Nocturnal use, if stable and provided the use is at least 12 hours prior to a trial visit, is allowed – Chronic opioid therapy using a Schedule 8 drug – Sedative antihistamines (taken in the daytime) – Current use of cannabis/marijuana, or THC-containing medications
  • Medical History: Inclusion Criteria: – Positive MDD primary diagnosis (confirmed at screening visit) with self-reported subjective cognitive dysfuntion Exclusion Criteria: – Active suicidal ideation – History of clinically diagnosed dementia – History of severe depression treated with electroconvulsive therapy – Treatment with transcranial magnetic stimulation within 3 months prior to enrolment – History of liver disease requiring medical intervention or persisitent liver function test elevations (unless due to Gilbert’s Syndrome) – History of significant hypoglycaemia in the past 5 years – History of disease related to the hypothalamus, the pituitary and/or the adrenal glands – History of medically diagnosed peripheral neuropathy – Active malignancy (excluding local BCC or SCC) – Known allergy to trial drug or any excipients of the formulation (including lactose, talc, magnesium stearate, croscarmellose sodium)
  • Smoking History: Eligible if: – ≤5 cigarettes a day or equivalent nicotine/tobacco products (including vaping) – Willing to abstain from nicotine/tobacco products on cognitive testing days

Outpatient Visits

  • 6 visits

Payment/Remuneration

  • $150 per visit completed (max total $900)

How to apply

To register your interest in this trial, please complete this form, or call us on 1800-FUSION (1800 387 466). A Fusion team member will be in contact to discuss your eligibility shortly.