MedTrace Logo

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

NCT01404130 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2011-07-27

No results posted yet for this study

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.

Conditions

  • Acne Vulgaris

Interventions

DRUG

Isotretinoin

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

Sponsors & Collaborators

  • University of Aberdeen

    lead OTHER

Principal Investigators

  • Anthony Ormerod, MB MD FRCP · University of Aberdeen

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404130 on ClinicalTrials.gov