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Trial record 15 of 165 for:    ISOTRETINOIN

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01404130
Recruitment Status : Completed
First Posted : July 27, 2011
Last Update Posted : July 27, 2011
Sponsor:
Information provided by:
University of Aberdeen

Tracking Information
First Submitted Date  ICMJE July 19, 2011
First Posted Date  ICMJE July 27, 2011
Last Update Posted Date July 27, 2011
Study Start Date  ICMJE September 2008
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
Cognitive change measured by delayed matching to sample (CANTAB) [ Time Frame: 3 months on treatment ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2011)
  • Change in spacial recognition memory (CANTAB) [ Time Frame: 0, 3 months and one month after stopping ]
  • Change in Paired Associate learning (CANTAB) [ Time Frame: 0, 3 months and one month after stopping ]
  • Change in Spacial recognition memory [ Time Frame: 0, 3months and one month after stopping ]
  • Cambridge gambling task - changes [ Time Frame: 0, 3months and one month after stopping ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
Official Title  ICMJE A Pilot Study of the Effects of Isotretinoin on Cognition, Learning and Memory
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. 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acne Vulgaris
Intervention  ICMJE Drug: Isotretinoin
0.5-1mg/kg daily for 4-6 months
Other Name: Accutane, Roaccutane, 13-cid retinoic acid
Study Arms  ICMJE Experimental: Isotretinoin therapy
0.5-1mg /kg titrated by clinical need and tolerance of each patient according to normal clinical practice
Intervention: Drug: Isotretinoin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2011)
18
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01404130
Other Study ID Numbers  ICMJE 07/S0802/135
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Anthony D Ormerod Principal Investigator, University of Aberden
Study Sponsor  ICMJE University of Aberdeen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anthony Ormerod, MB MD FRCP University of Aberdeen
PRS Account University of Aberdeen
Verification Date July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP