Depression in RemissionPROGRESSNCT05220228
Prucalopride and Cognition in Recovered Depression
A study testing Prucalopride in people with Depression in Remission, run by University of Oxford at 1 site in United Kingdom.
Trial 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. To explore if prucalopride has an effect on emotional processing biases consistent with its effects on serotonin. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression in Remission
- What is being tested?
- Prucalopride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Jan 2022to 13 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Department of Psychiatry, Warneford Hospital, University of Oxford
Oxford, Oxfordshire
About this study
Official title: The Effect of 2mg Sub-acute Prucalopride on Cognition and Emotional Processing in Participants Recovered From Depression
The current study has two aims:
- To test the effect of 5-HT4 receptor agonism on cognition (including memory, attention and cognitive control) in individuals with previous history of depression.
- To explore if prucalopride has an effect on emotional processing biases consistent with its effects on serotonin.
Read the 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 remission of mood symptoms. Therefore, it may be clinically beneficial to search for new therapies that are able to improve cognition in those who have, or are recovering from, depression.
Agonists of the serotonin receptor subtype 4 (5-HT4) have shown two profiles of effect in animal models: (i) a pro-cognitive profile, improving in learning and memory on a range of rodent paradigms; and (ii) an antidepressant-like profile, reducing depression and anxiety-related behaviours in rodent models of depression and anxiety.
A previous study in our group examining acute prucalopride administration (1mg) in 40 healthy human volunteers found improvements in learning and memory but little effect on emotional processing. This pro-cognitive effect was supported by a subsequent study where healthy volunteers received 7 days of prucalopride. In this study, prucalopride led to both better performance on a visual memory task, and increased activation in the hippocampus and an associated memory processing region in response to a memory stimulus. As short-term treatment with clinically-effective antidepressants such as SSRIs is known to produce positive biases in the processing of emotional information in healthy volunteers, this lack of effect on emotional processing was not consistent with prucalopride having antidepressant potential, and is surprising considering the strength of the animal data. One factor that has not yet been explored is whether the translation was limited due to the low dose of prucalopride used in our previous study.
Therefore, we wish to see if we (i) can translate this pro-cognitive effect of prucalopride into participants with a previous history of depression and current mild cognitive issues; and (ii) can use a full treatment dose of prucalopride to evaluate its effect on emotional processing.
- Conditions
- Depression in Remission
- Being tested
- Prucalopride, Placebo
- Keywords
- Cognition, Emotional processing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resolor, Montegrity, Axunio
1mg prucalopride x 2d, 2mg prucalopride x 5-8d
PlaceboDrug
Lactose / sucrose placebo
| Study group | Role | What they receive |
|---|---|---|
| Prucalopride | Experimental | Prucalopride - 1mg for 2 days, and then increased to 2mg for a further 5-8 days. Testing will occur on day 7 ideally, but may take place up to and including day 10. Receives: Drug: Prucalopride |
| Placebo | Placebo comparator | Placebo (sucrose / lactose) for 7-10 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance (accuracy) across cognitive battery
To investigate the pattern of effects of sub-acute administration of 2mg prucalopride versus placebo on a battery of cognitive measures including attention (DSST), memory (AVLT), executive function (TMT-A/B), working memory (N-back), and reward sensitivity (PILT).
Measured: Day 7-10
Secondary outcomes (5)
FERT
Accuracy (%) and reaction times on computer-based task of facial expression recognition (FERT), comparing those receiving drug and placebo.
Measured: D7-10
ECAT/EREC/EMEM
Number of positive and negative words correctly categorised, recalled, and recognised on emotional memory task, comparing those receiving drug and placebo.
Measured: D7-10
FDOT
Reaction times to fearful, happy, and neutral faces in masked and unmasked conditions (FDOT), comparing those receiving drug and placebo.
Measured: D7-10
Emotional go/no-go
Reaction time and accuracy, comparing those receiving drug and placebo.
Measured: D7-10
PDQ-20
Change of score from baseline, comparing those receiving drug and placebo.
Measured: D7-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start4 Jan 2022
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in RemissionStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Angharad de Cates, MRCPsych, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05220228
- Sponsor's protocol ID
- R77135/RE001
- Acronym
- PROGRESS
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of 2mg Sub-acute Prucalopride on Cognition and Emotional Processing in Participants Recovered From Depression
- ClinicalTrials.gov ID
- NCT05220228
- Acronym / sponsor ID
- PROGRESS / R77135/RE001
- Conditions
- Depression in Remission
- Keywords
- Cognition, Emotional processing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study has two aims:
- To test the effect of 5-HT4 receptor agonism on cognition (including memory, attention and cognitive control) in individuals with previous history of depression.
- To explore if prucalopride has an effect on emotional processing biases consistent with its effects on serotonin.
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 remission of mood symptoms. Therefore, it may be clinically beneficial to search for new therapies that are able to improve cognition in those who have, or are recovering from, depression.
Agonists of the serotonin receptor subtype 4 (5-HT4) have shown two profiles of effect in animal models: (i) a pro-cognitive profile, improving in learning and memory on a range of rodent paradigms; and (ii) an antidepressant-like profile, reducing depression and anxiety-related behaviours in rodent models of depression and anxiety.
A previous study in our group examining acute prucalopride administration (1mg) in 40 healthy human volunteers found improvements in learning and memory but little effect on emotional processing. This pro-cognitive effect was supported by a subsequent study where healthy volunteers received 7 days of prucalopride. In this study, prucalopride led to both better performance on a visual memory task, and increased activation in the hippocampus and an associated memory processing region in response to a memory stimulus. As short-term treatment with clinically-effective antidepressants such as SSRIs is known to produce positive biases in the processing of emotional information in healthy volunteers, this lack of effect on emotional processing was not consistent with prucalopride having antidepressant potential, and is surprising considering the strength of the animal data. One factor that has not yet been explored is whether the translation was limited due to the low dose of prucalopride used in our previous study.
Therefore, we wish to see if we (i) can translate this pro-cognitive effect of prucalopride into participants with a previous history of depression and current mild cognitive issues; and (ii) can use a full treatment dose of prucalopride to evaluate its effect on emotional processing.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prucalopride | Experimental | Drug: PrucalopridePrucalopride - 1mg for 2 days, and then increased to 2mg for a further 5-8 days. Testing will occur on day 7 ideally, but may take place up to and including day 10. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (sucrose / lactose) for 7-10 days |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucaloprideAlso: Resolor, Montegrity, Axunio1mg prucalopride x 2d, 2mg prucalopride x 5-8d | Drug | Prucalopride |
| PlaceboLactose / sucrose placebo | Drug | Placebo |
Primary outcome
Performance (accuracy) across cognitive battery
Time frame: Day 7-10
To investigate the pattern of effects of sub-acute administration of 2mg prucalopride versus placebo on a battery of cognitive measures including attention (DSST), memory (AVLT), executive function (TMT-A/B), working memory (N-back), and reward sensitivity (PILT).
5 secondary outcomes
FERT
Time frame: D7-10
ECAT/EREC/EMEM
Time frame: D7-10
FDOT
Time frame: D7-10
Emotional go/no-go
Time frame: D7-10
PDQ-20
Time frame: D7-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Angharad de Cates, MRCPsych principal investigator
University of Oxford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prucalopride in people with Depression in Remission, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance (accuracy) across cognitive battery (time frame: Day 7-10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.