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

This study has been completed.
Sponsor:
Information provided by:
University of Aberdeen
ClinicalTrials.gov Identifier:
NCT01404130
First received: July 19, 2011
Last updated: July 26, 2011
Last verified: July 2011
  Purpose

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.

Condition Intervention Phase
Acne Vulgaris
Drug: Isotretinoin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory

Resource links provided by NLM:


Further study details as provided by University of Aberdeen:

Primary Outcome Measures:
  • Cognitive change measured by delayed matching to sample (CANTAB) [ Time Frame: 3 months on treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change in spacial recognition memory (CANTAB) [ Time Frame: 0, 3 months and one month after stopping ] [ Designated as safety issue: Yes ]
  • Change in Paired Associate learning (CANTAB) [ Time Frame: 0, 3 months and one month after stopping ] [ Designated as safety issue: Yes ]
  • Change in Spacial recognition memory [ Time Frame: 0, 3months and one month after stopping ] [ Designated as safety issue: Yes ]
  • Cambridge gambling task - changes [ Time Frame: 0, 3months and one month after stopping ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: September 2008
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Accutane, Roaccutane, 13-cid retinoic acid

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01404130

Locations
United Kingdom
Anthony Ormerod
Aberdeen, Aberdeenshire, United Kingdom, AB25 2AN
Sponsors and Collaborators
University of Aberdeen
Investigators
Principal Investigator: Anthony Ormerod, MB MD FRCP University of Aberdeen
  More Information

No publications provided

Responsible Party: Dr Anthony D Ormerod Principal Investigator, University of Aberden
ClinicalTrials.gov Identifier: NCT01404130     History of Changes
Other Study ID Numbers: 07/S0802/135
Study First Received: July 19, 2011
Last Updated: July 26, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Aberdeen:
isotretinoin
hippocampus
memory
learning
CANTAB

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Isotretinoin
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014