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

Primary Purpose

Acne Vulgaris

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Isotretinoin
Sponsored by
University of Aberdeen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Vulgaris focused on measuring isotretinoin, hippocampus, memory, learning, CANTAB

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Anthony Ormerod

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Isotretinoin therapy

Arm Description

0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice

Outcomes

Primary Outcome Measures

Cognitive change measured by delayed matching to sample (CANTAB)

Secondary Outcome Measures

Change in spacial recognition memory (CANTAB)
Change in Paired Associate learning (CANTAB)
Change in Spacial recognition memory
Cambridge gambling task - changes

Full Information

First Posted
July 19, 2011
Last Updated
July 26, 2011
Sponsor
University of Aberdeen
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1. Study Identification

Unique Protocol Identification Number
NCT01404130
Brief Title
A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
Official Title
A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aberdeen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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. Generate data for sample size calculation for a larger study to determine the changes in memory over time in drug and control group Test of CANTAB, questionnaires and data collection forms Select most appropriate outcome measures Identify therapy sensitive cognitive tasks which would be used in future functional brain imaging studies It was not considered to randomise subjects to placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
isotretinoin, hippocampus, memory, learning, CANTAB

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotretinoin therapy
Arm Type
Experimental
Arm Description
0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Other Intervention Name(s)
Accutane, Roaccutane, 13-cid retinoic acid
Intervention Description
0.5-1mg/kg daily for 4-6 months
Primary Outcome Measure Information:
Title
Cognitive change measured by delayed matching to sample (CANTAB)
Time Frame
3 months on treatment
Secondary Outcome Measure Information:
Title
Change in spacial recognition memory (CANTAB)
Time Frame
0, 3 months and one month after stopping
Title
Change in Paired Associate learning (CANTAB)
Time Frame
0, 3 months and one month after stopping
Title
Change in Spacial recognition memory
Time Frame
0, 3months and one month after stopping
Title
Cambridge gambling task - changes
Time Frame
0, 3months and one month after stopping

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult subjects age 16 and over with acne vulgaris 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: Subjects already on treatment with isotretinoin Subjects with below normal intelligence who would not understand the CANTAB psychological tests Subjects with neurological disease e.g. epilepsy or pre-existing mental health problems Pregnant females or females not taking preventive precautions Subjects on sedative or psycho-active medications that could interfere with the outcomes tested
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony Ormerod, MB MD FRCP
Organizational Affiliation
University of Aberdeen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anthony Ormerod
City
Aberdeen
State/Province
Aberdeenshire
ZIP/Postal Code
AB25 2AN
Country
United Kingdom

12. IPD Sharing Statement

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

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