The Effect of D-cycloserine on Emotional Processing

NCT ID: NCT03961464

Last Updated: 2019-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-10
• Study Completion Date: 2018-12-05

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.

Conditions

Cycloserine; Healthy Volunteer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

d-cycloserine

oral, capsule, 250 mg

Group Type: EXPERIMENTAL

d-cycloserine

Intervention Type: DRUG

Single dose

Placebo

oral, capsule, lactose

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Single dose

Interventions

d-cycloserine

Single dose

Intervention Type: DRUG

Placebo

Single dose

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Oxford

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

R57491/RE001

Identifier Type: -

Identifier Source: org_study_id