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

Acne Vulgaris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01404130
• Other study ID #: 07/S0802/135
• Status: Completed
• Phase: Phase 4
• First received: July 19, 2011
• Last updated: July 26, 2011
• Start date: September 2008
• Est. completion date: November 2010

Study information

• Verified date: July 2011
• Source: University of Aberdeen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Isotretinoin
0.5-1mg/kg daily for 4-6 months

Locations

Country	Name	City	State
United Kingdom	Anthony Ormerod	Aberdeen	Aberdeenshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Aberdeen

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cognitive change measured by delayed matching to sample (CANTAB)		3 months on treatment	Yes
Secondary	Change in spacial recognition memory (CANTAB)		0, 3 months and one month after stopping	Yes
Secondary	Change in Paired Associate learning (CANTAB)		0, 3 months and one month after stopping	Yes
Secondary	Change in Spacial recognition memory		0, 3months and one month after stopping	Yes
Secondary	Cambridge gambling task - changes		0, 3months and one month after stopping	Yes