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Trial record 28 of 120 for:    Anti-Bacterial | CYCLOSERINE OR SEROMYCIN

The Effect of D-cycloserine on Emotional Processing

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03961464
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : May 23, 2019
Sponsor:
Information provided by (Responsible Party):
University of Oxford

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

Condition or disease Intervention/treatment Phase
Cycloserine Healthy Volunteer Drug: d-cycloserine Drug: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: The Effect of NMDA Receptor Partial Agonist D-cycloserine on Emotional Processing, Stress and Memory in Healthy Volunteers
Actual Study Start Date : August 10, 2018
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
Drug Information available for: Cycloserine

Arm Intervention/treatment
Experimental: d-cycloserine
oral, capsule, 250 mg
Drug: d-cycloserine
Single dose

Experimental: Placebo
oral, capsule, lactose
Drug: Placebo
Single dose




Primary Outcome Measures :
  1. Performance in a facial expression recognition task [ Time Frame: 3 hours after drug/placebo administration ]
    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.

  2. Performance in an emotional recall task [ Time Frame: 3 hours after drug/placebo administration ]
    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. Performance in an autobiographical memory task [ Time Frame: 3 hours after drug/placebo administration ]
    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.


Secondary Outcome Measures :
  1. Performance in an emotional categorisation task [ Time Frame: 3 hours after drug/placebo administration ]
    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.

  2. Performance in an emotional faces dot probe task [ Time Frame: 3 hours after drug/placebo administration ]
    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).

  3. Performance in an emotional recognition task [ Time Frame: 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 ]
    3 hours after drug/placebo administration

  4. Performance in a cognitive stress task [ Time Frame: 3 hours after drug/placebo administration ]
    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.

  5. Performance in a facial expression recognition task [ Time Frame: 24 hours after drug/placebo administration ]
    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.

  6. Performance in an emotional recall task [ Time Frame: 24 hours after drug/placebo administration ]
    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.

  7. Performance in an autobiographical memory task [ Time Frame: 24 hours after drug/placebo administration ]
    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.


Other Outcome Measures:
  1. Change in subjective mood [ Time Frame: 3 hours after drug/placebo administration ]
    Positive and Negative Affect Schedule. Standard questionnaire for subjectively felt positive and negative affect. Two scores: (1) Positive score: ranging from 10 to 50 (higher score representing greater extent of positive affect). (2) Negative score: ranging from 10 to 50 (higher score representing greater extent of negative affect).

  2. Change in subjective anxiety [ Time Frame: 3 hours after drug/placebo administration ]
    State Anxiety Inventory. Standard questionnaire for subjectively felt anxiety. State anxiety: ranging from 20 to 80 (higher scores indicating higher state anxiety levels).

  3. Change in subjective energy [ Time Frame: 3 hours after drug/placebo administration ]
    Zersen's Befindlichkeits-Skala. Standard questionnaire for subjectively felt mood and energy levels. Total score ranging from 0 to 112. Subscores: Mood (ranging from 0 to 94) and Energy (ranging from 0 to 18). Sum of subscores for mood and energy provide total score. Higher scores represent worse subjective mood and energy

  4. Change in subjective state [ Time Frame: 3 hours after drug/placebo administration ]
    Visual Analogue Scales of different subjective states (happy, sad, interested, anxious, stressed, hostile, nausea, dizziness, dry mouth, headache, alert, agitation). Minimum = 0 mm ("Not at all") , Maximum = 100 mm ("Extremely"). Greater scores represent greater extent of felt emotions/side effects.

  5. Change in subjective anxiety for cognitive stress task [ Time Frame: After cognitive stress task ]
    State Anxiety Inventory. Standard questionnaire for subjectively felt anxiety. State anxiety: ranging from 20 to 80 (higher scores indicating higher state anxiety levels).

  6. Change in subjective mood for cognitive stress task [ Time Frame: After cognitive stress task ]
    Positive and Negative Affect Schedule. Standard questionnaire for subjectively felt positive and negative affect. Two scores: (1) Positive score: ranging from 10 to 50 (higher score representing greater extent of positive affect). (2) Negative score: ranging from 10 to 50 (higher score representing greater extent of negative affect).

  7. Change in subjective state for cognitive stress task [ Time Frame: After cognitive stress task ]
    Visual Analogue Scales of different subjective states (happy, sad, interested, anxious, stressed, hostile, nausea, dizziness, dry mouth, headache, alert, agitation). Minimum = 0 mm ("Not at all") , Maximum = 100 mm ("Extremely"). Greater scores represent greater extent of felt emotions/side effects.

  8. Physiological measures (Skin Conductance Response) for cognitive stress task [ Time Frame: During cognitive stress task ]
    The skin conductance response (SCR), also known as the electrodermal response is the phenomenon that the skin momentarily becomes a better conductor of electricity when either external or internal stimuli

  9. Physiological measures (blood pressure) for cognitive stress task [ Time Frame: During cognitive stress task ]
    Systolic and diastolic blood pressure are the two values that determine whether participant's blood pressure is normal, too high or too low.

  10. Change in subjective mood [ Time Frame: 24 hours after drug/placebo administration ]
    Positive and Negative Affect Schedule. Standard questionnaire for subjectively felt positive and negative affect. Two scores: (1) Positive score: ranging from 10 to 50 (higher score representing greater extent of positive affect). (2) Negative score: ranging from 10 to 50 (higher score representing greater extent of negative affect).

  11. Change in subjective anxiety [ Time Frame: 24 hours after drug/placebo administration ]
    State Anxiety Inventory. Standard questionnaire for subjectively felt anxiety. State anxiety: ranging from 20 to 80 (higher scores indicating higher state anxiety levels).

  12. Change in subjective energy [ Time Frame: 24 hours after drug/placebo administration ]
    Zersen's Befindlichkeits-Skala. Standard questionnaire for subjectively felt mood and energy levels. Total score ranging from 0 to 112. Subscores: Mood (ranging from 0 to 94) and Energy (ranging from 0 to 18). Sum of subscores for mood and energy provide total score. Higher scores represent worse subjective mood and energy

  13. Change in subjective state [ Time Frame: 24 hours after drug/placebo administration ]
    Visual Analogue Scales of different subjective states (happy, sad, interested, anxious, stressed, hostile, nausea, dizziness, dry mouth, headache, alert, agitation). Minimum = 0 mm ("Not at all") , Maximum = 100 mm ("Extremely"). Greater scores represent greater extent of felt emotions/side effects.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961464


Locations
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United Kingdom
University of Oxford
Oxford, United Kingdom, OX3 7JZ
Sponsors and Collaborators
University of Oxford

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03961464     History of Changes
Other Study ID Numbers: R57491/RE001
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Oxford:
Emotion processing
Autobiographical memory
Stress

Additional relevant MeSH terms:
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Cycloserine
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action