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CycloserineNCT03961464

The Effect of D-cycloserine on Emotional Processing

A study testing d-cycloserine in people with Cycloserine and Healthy Volunteer, run by University of Oxford at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cycloserine, Healthy Volunteer
What is being tested?
d-cycloserine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteUnited Kingdom
Study dates
10 Aug 2018to 5 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • University of Oxford

    Oxford, OX3 7JZ

Other trials in United Kingdom

About this study

Official title: The Effect of NMDA Receptor Partial Agonist D-cycloserine on Emotional Processing, Stress and Memory in Healthy Volunteers

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

Read the 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.

Being tested
d-cycloserine, Placebo
Keywords
Emotion processing, Autobiographical memory, Stress

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • d-cycloserineDrug

    Single dose

  • PlaceboDrug

    Single dose

Study groups in NCT03961464
Study groupRoleWhat they receive
d-cycloserineExperimentaloral, capsule, 250 mg
Receives: Drug: d-cycloserine
PlaceboExperimentaloral, capsule, lactose
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 hours after drug/placebo administration

  2. 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.

    Measured: 3 hours after drug/placebo administration

  3. 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.

    Measured: 3 hours after drug/placebo administration

Secondary outcomes (7)
  1. Performance in an emotional categorisation task

    Participants are presented with positive and negative personality descriptors and are asked to classify the valence of each word. These words describe either extremely agreeable/positive characteristics (e.g. "cheerful", "honest", "optimistic") or extremely disagreeable/negative characteristics (e.g. "domineering", "untidy", "hostile") and are presented individually in the centre of the screen. Participants are instructed to imagine themselves overhearing someone describing them with each of the words and to indicate as quickly and accurately as possible whether they would like or dislike to be described with each of the words. Responses are made by pressing a correspondingly labelled key on a button box. Reaction times for correct classifications are measured separately for positive and negative words.

    Measured: 3 hours after drug/placebo administration

  2. Performance in an emotional faces dot probe task

    Pictures of positive and negative emotional stimuli (happy and fearful facial expressions) are presented individually together with a matched neutral stimulus (neutral face). On each trial, one stimulus is shown above and the other below a central fixation point. Subsequently, a probe appears behind one of the stimuli and participants have to correctly classify the probe as quickly and as accurately as possible. Stimuli can be masked (i.e. presented very briefly and followed by a jumbled face) or unmasked (i.e. presented for a longer period without a subsequent masking stimulus). Reaction times for correct responses are recorded and vigilance scores are calculated for masked and unmasked positive and negative stimuli by subtracting reaction time data from trials when the probe appeared in the same position as the emotional stimulus (congruent trials) from trials when the probe appeared in the opposite position to the emotional stimulus (incongruent trials).

    Measured: 3 hours after drug/placebo administration

  3. Performance in an emotional recognition task

    3 hours after drug/placebo administration

    Measured: 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

  4. Performance in a cognitive stress task

    The computer stress task is designed to induce psychological stress.It is presented as a series of mental arithmetic, verbal and visuospatial challenges on the screen which participants are required to solve. In the stress condition, there is a time limit for completing each challenge, which is displayed on the screen as a time bar. To induce a high failure rate, the timing for each challenge is set depending on individual's previous performance at 10% less than the time that it took to previously correctly solve challenges. The difficulty of the challenges is automatically varied to ensure that participants are getting only 20-40% of the challenges correctly completed within the time. To ensure a high failure rate, some of the verbal challenges (anagrams) are impossible to solve. Participants are given feedback on their performance on the screen which indicates that they are performing badly.

    Measured: 3 hours after drug/placebo administration

  5. 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.

    Measured: 24 hours after drug/placebo administration

  6. Performance in an emotional recall task

    Participants are asked to recall and write down as many words as possible from yesterday's emotional categorization task. Numbers of correctly and incorrectly recalled positive and negative words are measured.

    Measured: 24 hours after drug/placebo administration

  7. 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.

    Measured: 24 hours after drug/placebo administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start10 Aug 2018
  3. Primary completion5 Dec 2018
  4. Study completion5 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961464
Sponsor's protocol ID
R57491/RE001
Status last verified
Jun 2018
First submitted
4 Mar 2019
Last updated
23 May 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing d-cycloserine in people with Cycloserine and Healthy Volunteer, run by University of Oxford at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Performance in a facial expression recognition task (time frame: 3 hours after drug/placebo administration). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2019.

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