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A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory

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. Identifier: NCT01404130
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : July 27, 2011
Information provided by:
University of Aberdeen

Brief Summary:

This prospective study tested the effects of isotretinoin in a cohort of patients receiving standard therapy for acne vulgaris. Subjects completed questionnaires and standardised computer based cognitive testing using CANTAB to test for cognitive effects particularly on learning and memory. Test were conducted before starting isotretinoin, after 3 months and again a month after finishing therapy. This was carried out as a pilot study to

  1. Test the hypothesis that oral isotretinoin, over its 4-month treatment time, will result in a decline in learning and memory as measured using the CANTAB series of test.
  2. Generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group
  3. Test of CANTAB, questionnaires and data collection forms
  4. Select most appropriate outcome measures
  5. Identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies It was not considered to randomise subjects to placebo.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: Isotretinoin Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
Study Start Date : September 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acne Memory

Arm Intervention/treatment
Experimental: Isotretinoin therapy
0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice
Drug: Isotretinoin
0.5-1mg/kg daily for 4-6 months
Other Name: Accutane, Roaccutane, 13-cid retinoic acid

Primary Outcome Measures :
  1. Cognitive change measured by delayed matching to sample (CANTAB) [ Time Frame: 3 months on treatment ]

Secondary Outcome Measures :
  1. Change in spacial recognition memory (CANTAB) [ Time Frame: 0, 3 months and one month after stopping ]
  2. Change in Paired Associate learning (CANTAB) [ Time Frame: 0, 3 months and one month after stopping ]
  3. Change in Spacial recognition memory [ Time Frame: 0, 3months and one month after stopping ]
  4. Cambridge gambling task - changes [ Time Frame: 0, 3months and one month after stopping ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Adult subjects age 16 and over with acne vulgaris
  2. Cases should be candidates for isotretinoin therapy should have severe acne not responding to treatment and at risk of scarring and have discussed the risks, pregnancy prevention program and benefits of this treatment according to normal clinical practise

Exclusion Criteria:

  1. Subjects already on treatment with isotretinoin
  2. Subjects with below normal intelligence who would not understand the CANTAB psychological tests
  3. Subjects with neurological disease e.g. epilepsy or pre-existing mental health problems
  4. Pregnant females or females not taking preventive precautions
  5. Subjects on sedative or psycho-active medications that could interfere with the outcomes tested

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 identifier (NCT number): NCT01404130

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United Kingdom
Anthony Ormerod
Aberdeen, Aberdeenshire, United Kingdom, AB25 2AN
Sponsors and Collaborators
University of Aberdeen
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Principal Investigator: Anthony Ormerod, MB MD FRCP University of Aberdeen
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Responsible Party: Dr Anthony D Ormerod Principal Investigator, University of Aberden Identifier: NCT01404130    
Other Study ID Numbers: 07/S0802/135
First Posted: July 27, 2011    Key Record Dates
Last Update Posted: July 27, 2011
Last Verified: July 2011
Keywords provided by University of Aberdeen:
Additional relevant MeSH terms:
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Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Dermatologic Agents