Selegiline and Reward Processing

October 16, 2019 updated by: University of Oxford

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.

Study Overview

Status

Unknown

Conditions

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 Type

Interventional

Enrollment (Anticipated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 38 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18-40 years of age
  • Able to give informed consent for study participation
  • Sufficient fluency in English to understand and complete the neuropsychological tasks

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Selegiline Group
27 healthy participants who will be administered a single 10mg tablet of selegiline hydrochloride.
Single 10mg tablet of Selegiline Hydrochloride
Placebo Comparator: Placebo Group
27 healthy participants who will be administered a single lactose tablet (placebo)
Single Placebo Tablet, identical appearance to experimental tablet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Tested one hour after selegiline/placebo ingestion
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.
Tested one hour after selegiline/placebo ingestion
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.
Tested one hour after selegiline/placebo ingestion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction Time (milliseconds) on the Faces Dot Probe Task (FDOT)
Time Frame: Tested one hour after selegiline/placebo ingestion
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.
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
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.
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
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.
Tested one hour after selegiline/placebo ingestion
Percentage Accuracy(%) on facial expression recognition task (FERT)
Time Frame: Tested one hour after selegiline/placebo ingestion
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.
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
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.
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
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.
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
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.
Tested one hour after selegiline/placebo ingestion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2019

Primary Completion (Anticipated)

September 10, 2020

Study Completion (Anticipated)

September 10, 2020

Study Registration Dates

First Submitted

September 24, 2019

First Submitted That Met QC Criteria

October 16, 2019

First Posted (Actual)

October 17, 2019

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

October 16, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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