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Completed

NCT Number: NCT01404130

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Anthony Ormerod

Aberdeen, Aberdeenshire, AB25 2AN, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subjects age 16 and over with acne vulgaris
  • 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

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

Treatment and study plan

isotretinoin

Drug

0.5-1mg/kg daily for 4-6 months

Other names: Accutane, Roaccutane, 13-cid retinoic acid

Primary outcomes

  1. Cognitive change measured by delayed matching to sample (CANTAB)

    Time frame: 3 months on treatment

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Aberdeen

Other

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Jul 27, 2011
Registry last updated
Jul 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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