HealthyNCT04130087
Selegiline and Reward Processing
A study testing Selegiline Hydrochloride 10 MG in people with Healthy, run by University of Oxford at 1 site in United Kingdom.
Trial summary
There has been growing interest in the relationship between reward processing and clinical symptoms of depression such as anhedonia (loss of interest and response to pleasurable activities). Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Selegiline Hydrochloride 10 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Sep 2019to 10 Sep 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age
- Able to give informed consent for study participation
- Sufficient fluency in English to understand and complete the neuropsychological tasks
Who cannot join
- Current usage of other regular medication (including the contraceptive pill, the Depo-Provera injection or the progesterone implant, and hormone replacement therapy)
- Any past or current Axis 1 DSM-IV psychiatric disorder
- Significant medical condition
- Pulse < 60 beats per minute at baseline screening
- Current or past gastro-intestinal disorder or irritable bowel syndrome
- Current pregnancy or breastfeeding
Show all 12Show fewer
- Known lactate deficiency or any other problem absorbing lactose, galactose or glucose
- Current or past history of drug or alcohol dependency
- Participation in a psychological or medical study involving the use of medication within the last 3 months
- Previous participation in a study using the same, or similar, emotional processing tasks
- Smoker > 5 cigarettes per day
- Typically drinks > 6 caffeinated drinks per day
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University of Oxford
Oxford, Oxfordshire, OX3 7JZ
Wendy Howard, PhD, 01865618286, wendy.howard@psych.ox.ac.uk
About this study
Official title: The Effects of a Single Dose on Reward and Emotional Processing in Healthy Volunteers
There has been growing interest in the relationship between reward processing and clinical symptoms of depression such as anhedonia (loss of interest and response to pleasurable activities).
The aim of the study is to investigate the acute effects of a single dose of selegiline (an irreversible monoamine oxidase B inhibitor) on reward and emotional processing in healthy volunteers.
Read the detailed description
There has been growing interest in the relationship between reward processing and clinical symptoms of depression such as anhedonia (loss of interest and response to pleasurable activities). Studies in animals have suggested that the neurotransmitter, dopamine, plays a key role in reward processing. This has given rise to the suggestion that in depression, decrements in dopamine activity lead to impaired reward processing which cause symptoms such as anhedonia and low motivation.
Research in humans into dopamine and reward is limited by suitable pharmacological means to manipulate dopamine activity safely and effectively.
To our knowledge, no previous research has studied the effects of acute administration of the licensed drug, selegiline, on reward and emotional processing. However, a single dose of selegiline effectively inhibits monoamine oxidase B (MAO-B), which should lead to increased dopamine availability in the CNS. Therefore, selegiline may be a useful tool to explore the effect of modifying dopamine availability on reward processing. Acquiring such knowledge through this study could assist in the clinical use of MAO-B inhibition as a target to ameliorate symptoms such as anhedonia as well as increasing our general understanding of reward processing in healthy individuals.
The aim of this study is to explore the effects of acute administration of a standard (10mg) dose of selegiline on reward and emotional processing versus a placebo, in healthy volunteers. At this dose selegiline only has an -MAO-B function therefore the specific impact of MAO-B blockade on reward and emotional processing can be explored.
Research Question: What effect will the administration of a single dose of selegiline have on reward and emotional processing in healthy volunteers?
- Conditions
- Healthy
- Being tested
- Selegiline Hydrochloride 10 MG, Placebo
- Keywords
- Reward, Selegiline, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selegiline Hydrochloride 10 MGDrug
Single 10mg tablet of Selegiline Hydrochloride
PlaceboDrug
Single Placebo Tablet, identical appearance to experimental tablet.
| Study group | Role | What they receive |
|---|---|---|
| Selegiline Group | Experimental | 27 healthy participants who will be administered a single 10mg tablet of selegiline hydrochloride. Receives: Drug: Selegiline Hydrochloride 10 MG |
| Placebo Group | Placebo comparator | 27 healthy participants who will be administered a single lactose tablet (placebo) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total monetary amount won in reward learning task.
During this task participants have to repeatedly choose between 2 options. On each trial one of the options, if chosen by the participant, will result in the participant winning money. The participant simply has to learn which is the best option to choose so as to win as much money as possible.
Measured: Tested one hour after selegiline/placebo ingestion
Reaction times (milliseconds) in reward learning task
During this task participants have to repeatedly choose between 2 options. On each trial one of the options, if chosen by the participant, will result in the participant winning money. The participant simply has to learn which is the best option to choose so as to win as much money as possible.
Measured: Tested one hour after selegiline/placebo ingestion
Reward sensitivity in reward learning task
During this task participants have to repeatedly choose between 2 options. On each trial one of the options, if chosen by the participant, will result in the participant winning money. The participant simply has to learn which is the best option to choose so as to win as much money as possible.
Measured: Tested one hour after selegiline/placebo ingestion
Secondary outcomes (7)
Reaction Time (milliseconds) on the Faces Dot Probe Task (FDOT)
The FDOT assesses attention to positive versus negative stimuli using a reaction time measure. Two faces are presented vertically on the computer screen and replaced by a pair of dots, to which the participant has to respond by indicating whether the dots are vertically or horizontally aligned. On some trials, one of the two faces presented has an emotional expression (fearful or happy). On half of the trials, the faces are presented very briefly and immediately replaced by a jumbled face mask. The reaction time to respond to the dots can be used as a measure of attention to the emotional faces.
Measured: Tested one hour after selegiline/placebo ingestion
Reaction time (milliseconds) in an Emotional Categorisation Task (ECAT)
The ECAT assesses speed to respond to positive and negative self-referent personality descriptors. Sixty personality characteristics (30 per valence) selected to be disagreeable (eg, sneering, untidy, hostile) or agreeable (eg, cheerful, honest, optimistic) are presented. The participants are asked whether they would like or dislike to be referred to as each characteristic.
Measured: Tested one hour after selegiline/placebo ingestion
Performance (number of words recalled) in an emotional recall task (EREC)
The EREC is a surprise free recall task to assess the incidental encoding of emotional stimuli. Participants are asked to recall as many of the words previously presented in the ECAT task (See Outcome Measure 4) as they can. The relative recall of positive versus negative words gives a measure of emotional biases in memory. This task is not computerised - participants write the recalled words on paper.
Measured: Tested one hour after selegiline/placebo ingestion
Percentage Accuracy(%) on facial expression recognition task (FERT)
The FERT assesses the interpretation of facial expressions. Faces with seven different basic emotions (happiness, fear, anger, disgust, sadness, surprise, neutral) are displayed on the screen and participants are required to indicate the expression on the face via a button-press. Different intensity levels of each emotion are presented, which increases the ambiguity of the facial expression and the sensitivity of the task.
Measured: Tested one hour after selegiline/placebo ingestion
Reaction times (milliseconds) on facial expression recognition task (FERT)
The FERT assesses the interpretation of facial expressions. Faces with seven different basic emotions (happiness, fear, anger, disgust, sadness, surprise, neutral) are displayed on the screen and participants are required to indicate the expression on the face via a button-press. Different intensity levels of each emotion are presented, which increases the ambiguity of the facial expression and the sensitivity of the task.
Measured: Tested one hour after selegiline/placebo ingestion
Percentage accuracy (%) in an Emotional Recognition Memory Task (EMEM)
The EMEM measures recognition memory for affective words. Participants are presented with a series of words comprising the pleasant and unpleasant personality words that were previously presented to them in the ECAT, and a set of previously unseen distracter words. For each word, participants are required to report whether they have previously seen the word.
Measured: Tested one hour after selegiline/placebo ingestion
Reaction times (milliseconds) in Emotional Recognition Memory Task (EMEM)
The EMEM measures recognition memory for affective words. Participants are presented with a series of words comprising the pleasant and unpleasant personality words that were previously presented to them in the ECAT, and a set of previously unseen distracter words. For each word, participants are required to report whether they have previously seen the word.
Measured: Tested one hour after selegiline/placebo ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start18 Sep 2019
- Primary completion10 Sep 2020 (estimated)
- Study completion10 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo controlled trial. 27 participants will be allocated to receive a single 10mg of selegiline and the same number will receive a single dose of placebo (lactose tablet.)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Harmer, PhD, Principal investigator, University of Oxford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130087
- Sponsor's protocol ID
- R64689/RE001
- Status last verified
- Sep 2019
- First submitted
- 24 Sep 2019
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vrieze E, Pizzagalli DA, Demyttenaere K, Hompes T, Sienaert P, de Boer P, Schmidt M, Claes S. Reduced reward learning predicts outcome in major depressive disorder. Biol Psychiatry. 2013 Apr 1;73(7):639-45. doi: 10.1016/j.biopsych.2012.10.014. Epub 2012 Dec 8.
PubMed 23228328Admon R, Pizzagalli DA. Dysfunctional Reward Processing in Depression. Curr Opin Psychol. 2015 Aug 1;4:114-118. doi: 10.1016/j.copsyc.2014.12.011.
PubMed 26258159Krystal JH, Sanacora G, Duman RS. Rapid-acting glutamatergic antidepressants: the path to ketamine and beyond. Biol Psychiatry. 2013 Jun 15;73(12):1133-41. doi: 10.1016/j.biopsych.2013.03.026.
PubMed 23726151Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.
PubMed 19397926Heinonen EH, Anttila MI, Nyman LM, Pyykko KA, Vuorinen JA, Lammintausta RA. Inhibition of platelet monoamine oxidase type B by selegiline. J Clin Pharmacol. 1997 Jul;37(7):597-601. doi: 10.1002/j.1552-4604.1997.tb04341.x.
PubMed 9243352
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Single Dose on Reward and Emotional Processing in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04130087
- Acronym / sponsor ID
- R64689/RE001
- Conditions
- Healthy
- Keywords
- Reward, Selegiline, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 10 Sep 2020 (estimated)
- Study completion
- 10 Sep 2020 (estimated)
- First posted
- 17 Oct 2019 (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.
There has been growing interest in the relationship between reward processing and clinical symptoms of depression such as anhedonia (loss of interest and response to pleasurable activities).
The aim of the study is to investigate the acute effects of a single dose of selegiline (an irreversible monoamine oxidase B inhibitor) on reward and emotional processing in healthy volunteers.
Detailed description
There has been growing interest in the relationship between reward processing and clinical symptoms of depression such as anhedonia (loss of interest and response to pleasurable activities). Studies in animals have suggested that the neurotransmitter, dopamine, plays a key role in reward processing. This has given rise to the suggestion that in depression, decrements in dopamine activity lead to impaired reward processing which cause symptoms such as anhedonia and low motivation.
Research in humans into dopamine and reward is limited by suitable pharmacological means to manipulate dopamine activity safely and effectively.
To our knowledge, no previous research has studied the effects of acute administration of the licensed drug, selegiline, on reward and emotional processing. However, a single dose of selegiline effectively inhibits monoamine oxidase B (MAO-B), which should lead to increased dopamine availability in the CNS. Therefore, selegiline may be a useful tool to explore the effect of modifying dopamine availability on reward processing. Acquiring such knowledge through this study could assist in the clinical use of MAO-B inhibition as a target to ameliorate symptoms such as anhedonia as well as increasing our general understanding of reward processing in healthy individuals.
The aim of this study is to explore the effects of acute administration of a standard (10mg) dose of selegiline on reward and emotional processing versus a placebo, in healthy volunteers. At this dose selegiline only has an -MAO-B function therefore the specific impact of MAO-B blockade on reward and emotional processing can be explored.
Research Question: What effect will the administration of a single dose of selegiline have on reward and emotional processing in healthy volunteers?
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo controlled trial. 27 participants will be allocated to receive a single 10mg of selegiline and the same number will receive a single dose of placebo (lactose tablet.)
| Arm | Type | Receives |
|---|---|---|
| Selegiline Group | Experimental | Drug: Selegiline Hydrochloride 10 MG27 healthy participants who will be administered a single 10mg tablet of selegiline hydrochloride. |
| Placebo Group | Placebo comparator | Drug: Placebo27 healthy participants who will be administered a single lactose tablet (placebo) |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-40 years of age
- Able to give informed consent for study participation
- Sufficient fluency in English to understand and complete the neuropsychological tasks
Key exclusion criteria (12 listed)
- Current usage of other regular medication (including the contraceptive pill, the Depo-Provera injection or the progesterone implant, and hormone replacement therapy)
- Any past or current Axis 1 DSM-IV psychiatric disorder
- Significant medical condition
- Pulse < 60 beats per minute at baseline screening
- Current or past gastro-intestinal disorder or irritable bowel syndrome
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 |
|---|---|---|
| Selegiline Hydrochloride 10 MGSingle 10mg tablet of Selegiline Hydrochloride | Drug | Selegiline Group |
| PlaceboSingle Placebo Tablet, identical appearance to experimental tablet. | Drug | Placebo Group |
Primary outcome
Total monetary amount won in reward learning task.
Time frame: Tested one hour after selegiline/placebo ingestion
During this task participants have to repeatedly choose between 2 options. On each trial one of the options, if chosen by the participant, will result in the participant winning money. The participant simply has to learn which is the best option to choose so as to win as much money as possible.
Reaction times (milliseconds) in reward learning task
Time frame: Tested one hour after selegiline/placebo ingestion
During this task participants have to repeatedly choose between 2 options. On each trial one of the options, if chosen by the participant, will result in the participant winning money. The participant simply has to learn which is the best option to choose so as to win as much money as possible.
Reward sensitivity in reward learning task
Time frame: Tested one hour after selegiline/placebo ingestion
During this task participants have to repeatedly choose between 2 options. On each trial one of the options, if chosen by the participant, will result in the participant winning money. The participant simply has to learn which is the best option to choose so as to win as much money as possible.
7 secondary outcomes
Reaction Time (milliseconds) on the Faces Dot Probe Task (FDOT)
Time frame: Tested one hour after selegiline/placebo ingestion
Reaction time (milliseconds) in an Emotional Categorisation Task (ECAT)
Time frame: Tested one hour after selegiline/placebo ingestion
Performance (number of words recalled) in an emotional recall task (EREC)
Time frame: Tested one hour after selegiline/placebo ingestion
Percentage Accuracy(%) on facial expression recognition task (FERT)
Time frame: Tested one hour after selegiline/placebo ingestion
Reaction times (milliseconds) on facial expression recognition task (FERT)
Time frame: Tested one hour after selegiline/placebo ingestion
Percentage accuracy (%) in an Emotional Recognition Memory Task (EMEM)
Time frame: Tested one hour after selegiline/placebo ingestion
Reaction times (milliseconds) in Emotional Recognition Memory Task (EMEM)
Time frame: Tested one hour after selegiline/placebo ingestion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Background: PubMed 23228328Vrieze E, Pizzagalli DA, Demyttenaere K, Hompes T, Sienaert P, de Boer P, Schmidt M, Claes S. Reduced reward learning predicts outcome in major depressive disorder. Biol Psychiatry. 2013 Apr 1;73(7):639-45. doi: 10.1016/j.biopsych.2012.10.014. Epub 2012 Dec 8.
- Background: PubMed 26258159Admon R, Pizzagalli DA. Dysfunctional Reward Processing in Depression. Curr Opin Psychol. 2015 Aug 1;4:114-118. doi: 10.1016/j.copsyc.2014.12.011.
- Background: PubMed 23726151Krystal JH, Sanacora G, Duman RS. Rapid-acting glutamatergic antidepressants: the path to ketamine and beyond. Biol Psychiatry. 2013 Jun 15;73(12):1133-41. doi: 10.1016/j.biopsych.2013.03.026.
- Background: PubMed 19397926Machado-Vieira R, Salvadore G, Diazgranados N, Zarate CA Jr. Ketamine and the next generation of antidepressants with a rapid onset of action. Pharmacol Ther. 2009 Aug;123(2):143-50. doi: 10.1016/j.pharmthera.2009.02.010. Epub 2009 May 3.
- Background: PubMed 9243352Heinonen EH, Anttila MI, Nyman LM, Pyykko KA, Vuorinen JA, Lammintausta RA. Inhibition of platelet monoamine oxidase type B by selegiline. J Clin Pharmacol. 1997 Jul;37(7):597-601. doi: 10.1002/j.1552-4604.1997.tb04341.x.
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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.
Catherine Harmer, PhD 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 Selegiline Hydrochloride 10 MG in people with Healthy, 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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mayowa Oyesanya, MD (01865 613 176, mayowa.oyesanya@conted.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total monetary amount won in reward learning task. (time frame: Tested one hour after selegiline/placebo ingestion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04130087, which also lists 5 linked publications.
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 17 Oct 2019.