The Effect of D-cycloserine on Emotional Processing

NCT03961464 | Completed

• 1 other identifier: R57491/RE001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the effects of N-methyl-D-aspartate (NMDA) partial agonist DCS on emotional processing, memory and stress tasks

Conditions

Cycloserine; Healthy Volunteer

Keywords

Emotion processing; Autobiographical memory; Stress

Outcome Measures

Primary Outcomes (3)

• Performance in a facial expression recognition task

  Participants are presented with individual pictures of facial expressions of emotions. Each presented face displays one of six basic emotions (anger, disgust, fear, happiness, sadness, or surprise). Each emotional expression is presented at different levels of intensity which have been created by combining shape and texture features of the two extremes "neutral" (0%) and "full prototypical emotion" (100%) to varying degrees. Examples of neutral facial expressions are presented as well. Participants are instructed to correctly classify each facial expression as angry, disgusted, fearful, happy, sad, surprised or neutral both as quickly and as accurately as possible. Responses are made by pushing one out of seven labelled keys on a response box. Hit rates, false alarm rates, and reaction times for correct classifications are measured separately for each emotion.

  3 hours after drug/placebo administration

• Performance in an emotional recall task

  Following a delay period after the emotional categorisation task (about 15 min), emotional recall memory is assessed. Participants are asked to recall and write down as many words as possible from the emotional categorization task. Numbers of correctly and incorrectly recalled positive and negative words are measured.

  3 hours after drug/placebo administration

• Performance in an autobiographical memory task

  The autobiographical memory cues are presented visually on computer screen in a fixed order, with positive, negative, and neutral words alternating, each word will be presented only once. Participants are instructed that, for each cue word, they should respond with a memory of an autobiographical event which had lasted less than 1 day and which had occurred at a specific time and place. They are told that the event could have occurred recently or a long time ago and could have been important or trivial but that no responses should be repeated for a subsequent word. Correct and incorrect examples are given. Responses are tape-recorded for subsequent coding.

  3 hours after drug/placebo administration

Secondary Outcomes (7)

• Performance in an emotional categorisation task

  3 hours after drug/placebo administration

• Performance in an emotional faces dot probe task

  3 hours after drug/placebo administration

• Performance in an emotional recognition task

  Emotional recognition memory is assessed by presenting participants with the original personality descriptors plus an equal number of matched distractor words (50% positive, 50% negative). Participants are asked to ind

• Performance in a cognitive stress task

  3 hours after drug/placebo administration

• Performance in a facial expression recognition task

  24 hours after drug/placebo administration

Other Outcomes (13)

• Change in subjective mood

  3 hours after drug/placebo administration

• Change in subjective anxiety

  3 hours after drug/placebo administration

• Change in subjective energy

  3 hours after drug/placebo administration

Study Arms (2)

d-cycloserine

EXPERIMENTAL

oral, capsule, 250 mg

Drug: d-cycloserine

Placebo

EXPERIMENTAL

oral, capsule, lactose

Drug: Placebo

Interventions

d-cycloserine DRUG

Single dose

d-cycloserine

Placebo DRUG

Single dose

Placebo

Eligibility Criteria

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

You may qualify if:

• Male or female
• Willing and able to give informed consent for participation in the study
• Body mass index (BMI) within the range of 19-30kg/m2
• Sufficiently fluent English to understand and complete the task

You may not qualify if:

• Currently take any psychoactive medication.
• Have taken any CNS-active medication during the last 6 weeks.
• Currently take any medication with cycloserine, ethionamide or isoniazid
• Have suffered from any past or current psychiatric disorder (e.g. depression, anxiety)
• Have lifetime history of epilepsy or other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
• Have history of heart disease, significant hypertension
• Have history of Megaloblastic Anaemia, Sideroblastic Anaemia
• Have history of kidney disease with reduction in kidney function
• Have severe renal impairment
• Have suffered from lactose intolerance
• Are currently pregnant, breastfeeding or trying to get pregnant
• Have a current or past history of drug or alcohol dependency
• Have participated in a psychological or medical study involving the use of medication within the last 3 months
• Have previously participated in a study using the same, or similar, emotional processing tasks
• Smoke more than 5 cigarettes per day

Sponsors & Collaborators

• University of Oxford: lead

Study Sites (1)

University of Oxford

Oxford, OX3 7JZ, United Kingdom

Location

MeSH Terms

Interventions

Cycloserine

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2019
• First Posted: May 23, 2019
• Study Start: August 10, 2018
• Primary Completion: December 5, 2018
• Study Completion: December 5, 2018
• Last Updated: May 23, 2019

Record last verified: 2018-06

Locations

GB (1)