An interventional study of d-cycloserine and Placebo in Cycloserine and Healthy Volunteer, sponsored by University of Oxford. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-23.
Sponsored by University of Oxford · Not applicable, Interventional, and Basic science
To investigate the effects of N-methyl-D-aspartate (NMDA) partial agonist DCS on emotional processing, memory and stress tasks
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.
University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.
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Exclusion Criteria:
oral, capsule, 250 mg
Drug: d-cycloserine
oral, capsule, lactose
Drug: Placebo
Single dose
Single dose
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.
Time frame: 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.
Time frame: 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.
Time frame: 3 hours after drug/placebo administration
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.
Time frame: 3 hours after drug/placebo administration
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).
Time frame: 3 hours after drug/placebo administration
Performance in an emotional recognition task
3 hours after drug/placebo administration
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
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.
Time frame: 3 hours after drug/placebo administration
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.
Time frame: 24 hours after drug/placebo administration
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.
Time frame: 24 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.
Time frame: 24 hours after drug/placebo administration
Change in subjective mood
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).
Time frame: 3 hours after drug/placebo administration
Change in subjective anxiety
State Anxiety Inventory. Standard questionnaire for subjectively felt anxiety. State anxiety: ranging from 20 to 80 (higher scores indicating higher state anxiety levels).
Time frame: 3 hours after drug/placebo administration
Change in subjective energy
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
Time frame: 3 hours after drug/placebo administration
Change in subjective state
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.
Time frame: 3 hours after drug/placebo administration
Change in subjective anxiety for 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).
Time frame: After cognitive stress task
Change in subjective mood for 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).
Time frame: After cognitive stress task
Change in subjective state for 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.
Time frame: After cognitive stress task
Physiological measures (Skin Conductance Response) for 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
Time frame: During cognitive stress task
Physiological measures (blood pressure) for 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.
Time frame: During cognitive stress task
Change in subjective mood
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).
Time frame: 24 hours after drug/placebo administration
Change in subjective anxiety
State Anxiety Inventory. Standard questionnaire for subjectively felt anxiety. State anxiety: ranging from 20 to 80 (higher scores indicating higher state anxiety levels).
Time frame: 24 hours after drug/placebo administration
Change in subjective energy
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
Time frame: 24 hours after drug/placebo administration
Change in subjective state
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.
Time frame: 24 hours after drug/placebo administration
Plan to share: Undecided
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