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

July 26, 2011 updated by: University of Aberdeen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Aberdeenshire
      • Aberdeen, Aberdeenshire, United Kingdom, AB25 2AN
        • Anthony Ormerod

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Investigators

  • Principal Investigator: Anthony Ormerod, MB MD FRCP, University of Aberdeen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

July 19, 2011

First Submitted That Met QC Criteria

July 26, 2011

First Posted (Estimate)

July 27, 2011

Study Record Updates

Last Update Posted (Estimate)

July 27, 2011

Last Update Submitted That Met QC Criteria

July 26, 2011

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07/S0802/135

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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