Selegiline and Reward Processing

NCT04130087 | Unknown

• 1 other identifier: R64689/RE001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Healthy

Keywords

Reward; Selegiline; Cognition

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Tested one hour after selegiline/placebo ingestion

Secondary Outcomes (7)

• Reaction Time (milliseconds) on the Faces Dot Probe Task (FDOT)

  Tested one hour after selegiline/placebo ingestion

• Reaction time (milliseconds) in an Emotional Categorisation Task (ECAT)

  Tested one hour after selegiline/placebo ingestion

• Performance (number of words recalled) in an emotional recall task (EREC)

  Tested one hour after selegiline/placebo ingestion

• Percentage Accuracy(%) on facial expression recognition task (FERT)

  Tested one hour after selegiline/placebo ingestion

• Reaction times (milliseconds) on facial expression recognition task (FERT)

  Tested one hour after selegiline/placebo ingestion

Study Arms (2)

Selegiline Group

EXPERIMENTAL

27 healthy participants who will be administered a single 10mg tablet of selegiline hydrochloride.

Drug: Selegiline Hydrochloride 10 MG

Placebo Group

PLACEBO COMPARATOR

27 healthy participants who will be administered a single lactose tablet (placebo)

Drug: Placebo

Interventions

Selegiline Hydrochloride 10 MG DRUG

Single 10mg tablet of Selegiline Hydrochloride

Selegiline Group

Placebo DRUG

Single Placebo Tablet, identical appearance to experimental tablet.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX3 7JZ, United Kingdom

RECRUITING

Related Publications (5)

• 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.

  PMID: 23228328 BACKGROUND

• Admon 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.

  PMID: 26258159 BACKGROUND

• Krystal 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.

  PMID: 23726151 BACKGROUND

• Machado-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.

  PMID: 19397926 BACKGROUND

• Heinonen 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.

  PMID: 9243352 BACKGROUND

MeSH Terms

Interventions

Selegiline

Intervention Hierarchy (Ancestors)

Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Catherine Harmer, PhD

  University of Oxford

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mayowa Oyesanya, MD

CONTACT

01865 613 176; mayowa.oyesanya@conted.ox.ac.uk

Wendy Howard, PhD

CONTACT

01865 618 286; wendy.howard@psych.ox.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A randomisation code will be drawn up by a researcher not involved in the study using a randomisation tool online (https://www.sealedenvelope.com/simple-randomiser/v1/lists). The study randomisation code will be kept in a sealed envelope in a dedicated cabinet in Neurosciences Building of The Department of Psychiatry. At the end of the study, the randomisation blind will be broken by the principal investigator by opening the randomisation code envelope. Blinding will be achieved by identical encapsulation of the selegiline and the placebo using the Departmental Standard Operating Procedure for drug encapsulation.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.)

Study Record Dates

• First Submitted: September 24, 2019
• First Posted: October 17, 2019
• Study Start: September 18, 2019
• Primary Completion: September 10, 2020
• Study Completion: September 10, 2020
• Last Updated: October 17, 2019

Record last verified: 2019-09

Locations

GB (1)