Status:
COMPLETED
Prucalopride and Cognition in Recovered Depression
Lead Sponsor:
University of Oxford
Conditions:
Depression in Remission
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The current study has two aims: 1. To test the effect of 5-HT4 receptor agonism on cognition (including memory, attention and cognitive control) in individuals with previous history of depression. 2....
Detailed Description
Cognitive impairment within depression is common and appears to be at least partly separate from the mood component. It is not well targeted by current treatments and it may persist even after remissi...
Eligibility Criteria
Inclusion
- Participant is willing and able to give informed consent for participation in the research
- Male or female
- Body mass index in the range of 18 to 33
- Not currently taking any medications (except for contraception), including being antidepressant free for at least three months
- Have at least two previous episodes of depression, and have been recovered from the most recent episode of depression for six months
- Current PHQ-9 score \< 10 (the cut off for DSM major depression)
Exclusion
- The participant may not enter the study if ANY of the following apply:
- Any current Axis 1 DSM-5 psychiatric disorder
- Any previous episode of a severe mental illness, other than Depressive Disorder. Comorbid Anxiety disorders will be allowed, but not OCD (Obsessive Compulsive Disorder) or PTSD.
- A first degree relative diagnosed with Bipolar Affective Disorder Type 1 or Schizophrenia
- Body Mass Index outside the range of 18 to 33 inclusive
- Any significant current medical condition likely to interfere with conduct of the study or analysis of data
- Current use of psychoactive and / or medically significant medication as judged by a study medic, whether prescribed or bought over the counter (the contraceptive pill, the Depo-Provera injection or the progesterone implant will not result in exclusion)
- Ongoing psychopharmacological treatment for depression, including hypnotics (psychotherapy will be allowed as long as not newly-started in the last 6 weeks)
- High consumption of licit substances to an extent that would make complying with study protocol challenging (including alcohol, caffeine, nicotine)
- Past history of dependence to illicit substances, and any consumption of illicit substances in the three months prior to the study
- Currently pregnant or breast feeding
- Current, or a significant history of, gastro-intestinal disorder or irritable bowel syndrome
- Known lactase deficiency or any other problem absorbing lactose, galactose, or glucose
- Participation in a study that involves the use of a medication or novel vaccine within the last three months
- Participation in a study using the same tasks in the last two years
- Any physical (including visual and auditory) or language impairment that would make complying with the study protocol challenging
Key Trial Info
Start Date :
January 4 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 13 2023
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05220228
Start Date
January 4 2022
End Date
November 13 2023
Last Update
February 9 2024
Active Locations (1)
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1
Department of Psychiatry, Warneford Hospital, University of Oxford
Oxford, Oxfordshire, United Kingdom