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Glutathione Levels and Compulsivity

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ClinicalTrials.gov Identifier: NCT02794389
Recruitment Status : Completed
First Posted : June 9, 2016
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:
The investigators will examine whether compulsivity in those who score above-average (but below clinical cut-off) on an eating disorder questionnaire can be altered by 9 days of N-acetyl cysteine (NAC). N-acetyl cysteine has been shown to be of some benefit in individuals with other compulsive disorders, such as trichotillomania and addiction, so this research investigates whether a short period of time taking N-acetyl cysteine changes compulsivity, measured using cognitive tasks and questionnaires.

Condition or disease Intervention/treatment Phase
Anorexia Nervosa Compulsive Behavior Drug: N-acetyl cysteine Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: How do Glutathione Levels Affect Compulsivity? A Double-blind, Placebo-controlled Study
Study Start Date : March 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: N-acetyl cysteine
1200mg for 2 days 2400mg for 7 days
Drug: N-acetyl cysteine
Placebo Comparator: Placebo
Magnesium stearate capsules
Drug: Placebo



Primary Outcome Measures :
  1. Change in scores on the Berg Card-Sort Task (a measure of set-shifting) when taking N-acetyl cysteine compared to placebo [ Time Frame: Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo. ]
    Improvement in scores on the Berg Card-Sort Task (a version of the Wisconsin Card Sorting Task) after NAC compared to placebo. Analyse using paired-sample t-tests on the perseverative error totals for each participant at each visit.


Secondary Outcome Measures :
  1. Change in scores on the Attention Switching Task when taking N-acetyl cysteine compared to placebo. [ Time Frame: Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo. ]
    Improvement in scores on the Attention Switching Task after NAC compared to placebo. Analyse using paired-sample t-tests.

  2. Change in score on the Affective Go/No-Go task (measuring attentional bias) when taking N-acetyl cysteine compared to placebo [ Time Frame: Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo. ]
    Improvement in scores on the Affective Go/No-Go task after NAC compared to placebo. Analyse using paired-sample t-tests.

  3. Change in scores on the Cambridge Gambling Task (measuring disadvantageous decision-making) when taking N-acetyl cysteine compared to placebo [ Time Frame: Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo. ]
    Change in scores on the Cambridge Gambling Task after NAC compared to placebo. Compare scores using paired-sample t-tests.

  4. Change in sequential learning task score (a measure of excessive habit-learning) when taking N-acetyl cysteine compared to placebo. [ Time Frame: Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo. ]
    Improvement in scores on the sequential learning task after NAC compared to placebo. Analyse by comparing beta weight of interaction effect between groups (NAC and placebo).

  5. Change in scores on delay discounting task when taking N-acetyl cysteine compared to placebo. [ Time Frame: Change between study visit on the 9th day of taking NAC, and the study visit on the 9th day of taking placebo. ]
    Change in scores on the delay discounting task after NAC compared to placebo. Analyse using paired-sample t-tests.

  6. To examine whether mood symptoms as indexed by the Hospital Anxiety and Depression Scale (HADS) change between baseline, N-acetyl cysteine administration and placebo administration. [ Time Frame: Change between screening visit, study visit on the 9th day of taking N-acetyl cysteine, and the study visit on the 9th day of taking placebo. ]
    Examine scores on HADS and see if they change over those 3 timepoints. Use paired-sample t-tests on the total score on the questionnaire. May also separate the sub-scales for anxiety and depression and perform paired t-tests on these too, if thought necessary.

  7. To examine whether eating disorder symptoms indexed by the EAT-26 change between baseline, N-acetyl cysteine administration, and placebo administration. [ Time Frame: Change between screening visit, study visit on the 9th day of taking N-acetyl cysteine, and the study visit on the 9th day of taking placebo. ]
    Examine scores on EAT-26 and see whether they change over those 3 timepoints. Use paired-sample t-tests.

  8. Examine change in score on the FERT when taking N-acetyl cysteine compared to placebo. [ Time Frame: After 9 days of taking N-acetyl cysteine and after 9 days of taking placebo. ]
    Change in performance on the FERT, analysed using an ANOVA to investigate whether there is an interaction effect in accuracy between emotion recognition and group (N-acetyl cysteine, placebo).

  9. Identify any difference in the side effect profile recorded daily during N-acetyl cysteine administration and placebo administration. [ Time Frame: After 9 days of taking N-acetyl cysteine and after 9 days of taking placebo. ]
    Significantly greater scores on side effect questionnaire during 9 days of NAC vs. placebo. Scores will be derived by totalling all side effects from all 9 days of each arm, with absent corresponding to a score of 0, mild corresponding to a score of 1, moderate corresponding to a score of 2, severe corresponding to a score of 3.

  10. Calculate the percentage of participants who correctly guess which treatment group they are in (N-acetyl cysteine vs. placebo). [ Time Frame: After 9 days of taking NAC and placebo for each participant. ]
    Examine the guesses made as to whether NAC/placebo was taken, and calculate percentages correct.



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

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Females aged 18 to 40 years.
  • Score between 9 and 19 on the EAT-26.
  • Participant is a fluent English speaker

Exclusion Criteria:

  • Any current psychotropic medications.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the study.
  • BMI below 18.5, indicating that they are underweight.
  • Any Axis I psychiatric disorder.
  • History of allergies to drugs or vaccines or any component of the NAC or placebo capsule (gelatine, magnesium stearate, NAC).
  • Pregnant, could be pregnant, breast feeding, or high risk of pregnancy (no reliable contraception use but sexual activity).
  • Has taken part in a psychological or medical experiment involving taking any kinds of drugs within the last 6 weeks.
  • Has had recent surgery.
  • Taking selenium, vitamin E, or NAC.
  • Current regular cigarette smoking of over 5 cigarettes per day.

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): NCT02794389


Locations
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United Kingdom
Department of Psychiatry, University of Oxford
Oxford, Oxfordshire, United Kingdom, OX3 7JX
Sponsors and Collaborators
University of Oxford
Investigators
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Principal Investigator: Phil J Cowen, Prof University of Oxford

Publications:

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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT02794389     History of Changes
Other Study ID Numbers: R44271/RE001
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by University of Oxford:
Acetylcysteine
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Compulsive Behavior
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Impulsive Behavior
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes