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

Phase 4

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: Isotretinoin

• Registration Number: NCT01404130
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2011-07
• Study First Submitted: 2011-07-19
• Study First Submitted QC: 2011-07-26
• Last Update Submitted: 2011-07-26
• Study First Posted: 2011-07-27
• Last Update Posted: 2011-07-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Isotretinoin therapy	Isotretinoin	0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice

Primary Outcome Measures

Name	Time	Method
Cognitive change measured by delayed matching to sample (CANTAB)	3 months on treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Anthony Ormerod; 🇬🇧 Aberdeen, Aberdeenshire, United Kingdom