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

NCT01404130 | Completed Phase 4

• 1 other identifier: 07/S0802/135
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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

1. 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. 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. 3.Test of CANTAB, questionnaires and data collection forms
4. 4.Select most appropriate outcome measures
5. 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

Keywords

isotretinoin; hippocampus; memory; learning; CANTAB

Outcome Measures

Primary Outcomes (1)

• Cognitive change measured by delayed matching to sample (CANTAB)

  3 months on treatment

Secondary Outcomes (4)

• Change in spacial recognition memory (CANTAB)

  0, 3 months and one month after stopping

• Change in Paired Associate learning (CANTAB)

  0, 3 months and one month after stopping

• Change in Spacial recognition memory

  0, 3months and one month after stopping

• Cambridge gambling task - changes

  0, 3months and one month after stopping

Study Arms (1)

Isotretinoin therapy

EXPERIMENTAL

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

Drug: Isotretinoin

Interventions

Isotretinoin DRUG

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

Also known as: Accutane, Roaccutane, 13-cid retinoic acid

Isotretinoin therapy

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Anthony Ormerod

Aberdeen, Aberdeenshire, AB25 2AN, United Kingdom

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Isotretinoin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Retinoids; Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors

Study Officials

• Anthony Ormerod, MB MD FRCP

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2011
• First Posted: July 27, 2011
• Study Start: September 1, 2008
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: July 27, 2011

Record last verified: 2011-07

Locations

GB (1)