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

Study Overview
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Brief Summary
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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 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. Generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group Test of CANTAB, questionnaires and data collection forms Select most appropriate outcome measures Identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies It was not considered to randomise subjects to placebo.

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

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Isotretinoin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotretinoin therapy<br>0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice | Drug: Isotretinoin<br>* 0.5-1mg/kg daily for 4-6 months<br>* Other names: Accutane, Roaccutane, 13-cid retinoic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive change measured by delayed matching to sample (CANTAB) |  | 3 months on treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spacial recognition memory (CANTAB) |  | 0, 3 months and one month after stopping | 
| Change in Paired Associate learning (CANTAB) |  | 0, 3 months and one month after stopping | 
| Change in Spacial recognition memory |  | 0, 3months and one month after stopping | 
| Cambridge gambling task - changes |  | 0, 3months and one month after stopping | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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isotretinoin, hippocampus, memory, learning, CANTAB