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Memory and Psychomotor Effects of Oxcarbazepine in healthy human volunteers

Memory and Psychomotor Effects of Oxcarbazepine in healthy human volunteers. Yana M. Van Arsdale, MD, PhD. Europian Journal of Clinical Pharmacology. Springer-Verlag 1993 Institute of Psychiatry, London, UK Preliminary finding was presented at the 19 th International Epilepsy Congress, 1991

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Memory and Psychomotor Effects of Oxcarbazepine in healthy human volunteers

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  1. Memory and Psychomotor Effects of Oxcarbazepine in healthy human volunteers Yana M. Van Arsdale, MD, PhD

  2. Europian Journal of Clinical Pharmacology • Springer-Verlag 1993 • Institute of Psychiatry, London, UK • Preliminary finding was presented at the 19th International Epilepsy Congress, 1991 • Supported by a grant from Ciba-Geigy

  3. 12 healthy individuals 5m, 7f, aged 21-39 Normal range height to weight ratio Recruited via advertisements within the Institute Paid for participation Screened: BMP, CBC, LFT, UA, ECG Subjects (inclusion criteria)

  4. Subjects • No OCP (females) • Informed consent • Ethical approval • Monitoring for Hyponatremia (suggested that hyponatremia is more prononced with OXCZ)

  5. Design • Double-blind • Balanced • Crossover • Comparison with placebo • Comparison between two doses of OXCZ • Progressive OXCZ administration over 15 days

  6. Procedure • Training session to practice all the tests • Tests were carried out on Days 1, 8 and 15 of EACH treatment period • Blood sample was taken on days 8 and 15 to measure plasma drug concentration & plasma Sodium levels

  7. Test Battery • Mental Rotation: Shepherd & Metzler (1971) – visuo-spatial working memory • Logic Task: Baddeley (1968) – executive component of working memory • Digit Span: Weschler (1955) • Word Recall – episodic memory • Pursuit Rotor – procedural learning

  8. Test Battery • News recall • Word Fluency • Finger Tapping • Digit Cancellation • Symbol Coping • EEG

  9. Test Battery • Critical Flicker Fusion Threshold (CFFT) • Subjective Ratings scale. Factors: 1. Alertness 2. Contentedness 3. Calmness • Subjective Ratings scale:Bodily Symptoms • Statistical Analyses

  10. Results

  11. Memory assessments:Baddley Logic test • No significant drug effect

  12. Memory assessment:Digit Span • Slight but Significant differences over: - testing days - times between high and low doses • Patterns of changes over time was inconsistent

  13. Memory Asssessments: Word Recall Pursuit Rotor News Recall Word Fluency Unaffected by treatment

  14. Psychomotor Assessments:Tapping Speed • Unaffected by treatment

  15. Psychomotor Assessments: Symbol Coping test • Marginal difference between placebo & active drug

  16. Psychomotor Assessments:Cancellation Time • Not significant

  17. Electroencephalogram • No significant differences

  18. Critical Flicker Fusion Threshold • No significant effects

  19. Mood Rating:“Alertness” • Significant interactions between: - day of treatment and drug group - day of treatment and dose of OXCZ • Effect larger for the highest dose & more pronounced on day 8

  20. Mood Ratings:“Contentedness” • Not affected by treatment

  21. Mood Ratings:“Calmness” • Marginal difference between: - dose levels • Revealed a main effect of drug

  22. Sodium Levels • WNL for all subjects on all treatments

  23. Discussion:Summary • Results are encouraging • OXCZ has a stimulant rather than cognitive enhancement effect • Objective tests: OXCZ improves performance on a Focused Attention tasks • Objective tests: OXCZ increases manual writing speed

  24. Discussion:Summary • Subjective rating: OXCZ increases feelings of - alertness - clearheadedness - quickwittedness • No effect on Long-Term Memory processes

  25. Limitations • Small Sample size (12) • Time consuming tests • No follow up • No comparison with patients groups • No psychiatric evaluations of individuals involved • Limited range of assessments of - attentional processes - psychomotor functions

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