Clinical trial NCT03961464: The Effect of D-cycloserine on Emotional Processing
Official title: The Effect of NMDA Receptor Partial Agonist D-cycloserine on Emotional Processing, Stress and Memory in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cycloserine
Healthy Volunteer
Keywords: Emotion processing
Autobiographical memory
Stress
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2019-05-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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

Detailed description: The aim of the present study is to assess the effect of DCS on emotional processing relevant to antidepressant drug activity. For this, 40 healthy volunteers will be recruited to the study and randomized to receive a single session of 250mg DCS or placebo. 3 hours and 24 hours after active drug/placebo administration, the effects of emotional processing via the use of cognitive tasks will be assessed. Also, given the important role of DCS in memory and stress, we also include tasks to explore changes in autobiographical memory and in psychological and physiological measures of stress and arousal.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Have dyslexia (given the nature of the computer tasks)

Primary outcomes:
measure: Performance in a facial expression recognition task
timeFrame: 3 hours after drug/placebo administration
measure: Performance in an emotional recall task
timeFrame: 3 hours after drug/placebo administration
measure: Performance in an autobiographical memory task
timeFrame: 3 hours after drug/placebo administration
Secondary outcomes:
measure: Performance in an emotional categorisation task
timeFrame: 3 hours after drug/placebo administration
measure: Performance in an emotional faces dot probe task
timeFrame: 3 hours after drug/placebo administration
measure: Performance in an emotional recognition task
timeFrame: 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
measure: Performance in a cognitive stress task
timeFrame: 3 hours after drug/placebo administration
measure: Performance in a facial expression recognition task
timeFrame: 24 hours after drug/placebo administration
measure: Performance in an emotional recall task
timeFrame: 24 hours after drug/placebo administration
measure: Performance in an autobiographical memory task
timeFrame: 24 hours after drug/placebo administration
Other outcomes:
measure: Change in subjective mood
timeFrame: 3 hours after drug/placebo administration
measure: Change in subjective anxiety
timeFrame: 3 hours after drug/placebo administration
measure: Change in subjective energy
timeFrame: 3 hours after drug/placebo administration
measure: Change in subjective state
timeFrame: 3 hours after drug/placebo administration
measure: Change in subjective anxiety for cognitive stress task
timeFrame: After cognitive stress task
measure: Change in subjective mood for cognitive stress task
timeFrame: After cognitive stress task
measure: Change in subjective state for cognitive stress task
timeFrame: After cognitive stress task
measure: Physiological measures (Skin Conductance Response) for cognitive stress task
timeFrame: During cognitive stress task
measure: Physiological measures (blood pressure) for cognitive stress task
timeFrame: During cognitive stress task
measure: Change in subjective mood
timeFrame: 24 hours after drug/placebo administration
measure: Change in subjective anxiety
timeFrame: 24 hours after drug/placebo administration
measure: Change in subjective energy
timeFrame: 24 hours after drug/placebo administration
measure: Change in subjective state
timeFrame: 24 hours after drug/placebo administration
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
Study officials:
References: