IPEG Guideline on Statistical Design and Analysis for Pharmacodynamic Trials

Ferber, Georg; K, Abt; Fichte, K; Luthringer, R.

doi:10.1159/000026567

Cited by 39 publications

(32 citation statements)

References 19 publications

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“…To this end, reference is made to the corresponding IPEG guidelines [71], which provide a set of recommendations for the investigation of the PD characteristics of a compound (e.g. time or dose effects) in the early phases of clinical drug development.…”

Section: Pharmaco-eeg – Statistical Analysismentioning

confidence: 99%

Guidelines for the Recording and Evaluation of Pharmaco-EEG Data in Man: The International Pharmaco-EEG Society (IPEG)

Jobert¹,

Wilson

Ruigt³

et al. 2012

Neuropsychobiology

145

132

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The International Pharmaco-EEG Society (IPEG) presents updated guidelines summarising the requirements for the recording and computerised evaluation of pharmaco-EEG data in man. Since the publication of the first pharmaco-EEG guidelines in 1982, technical and data processing methods have advanced steadily, thus enhancing data quality and expanding the palette of tools available to investigate the action of drugs on the central nervous system (CNS), determine the pharmacokinetic and pharmacodynamic properties of novel therapeutics and evaluate the CNS penetration or toxicity of compounds. However, a review of the literature reveals inconsistent operating procedures from one study to another. While this fact does not invalidate results per se, the lack of standardisation constitutes a regrettable shortcoming, especially in the context of drug development programmes. Moreover, this shortcoming hampers reliable comparisons between outcomes of studies from different laboratories and hence also prevents pooling of data which is a requirement for sufficiently powering the validation of novel analytical algorithms and EEG-based biomarkers. The present updated guidelines reflect the consensus of a global panel of EEG experts and are intended to assist investigators using pharmaco-EEG in clinical research, by providing clear and concise recommendations and thereby enabling standardisation of methodology and facilitating comparability of data across laboratories.

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Section: Pharmaco-eeg – Statistical Analysismentioning

confidence: 99%

Guidelines for the Recording and Evaluation of Pharmaco-EEG Data in Man: The International Pharmaco-EEG Society (IPEG)

Jobert¹,

Wilson

Ruigt³

et al. 2012

Neuropsychobiology

145

132

View full text Add to dashboard Cite

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“…Statistical analysis was based on the concept of descriptive data analysis (DDA) as proposed by Abt [40] and Ferber et al [41] for controlled clinical trials. The pre-determined null hypothesis for the confirmatory statement was: there is no difference between trazodone and placebo in regard to sleep efficiency (maximum error probability alpha = 0.05).…”

Section: Biometric Planning and Evaluationmentioning

confidence: 99%

Insomnia Related to Dysthymia: Polysomnographic and Psychometric Comparison with Normal Controls and Acute Therapeutic Trials with Trazodone

et al. 2001

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Utilizing polysomnography (PSG) and psychometry, objective and subjective sleep and awakening quality was investigated in 11 patients (mean age 50 ± 14) with nonorganic insomnia (F 51.0) related to dysthymia (F 34.1) as compared with 11 age- and sex-matched normal controls. Patients demonstrated decreased sleep efficiency and sleep stage S2 as well as increased sleep latency to S1, S2 and S3, wakefulness within the total sleep period, number of awakenings, S1 and REM sleep. There was no intergroup difference in REM latency. Subjective sleep quality and the total score of the Self-Assessment Scale for Sleep and Awakening Quality (SSA) were deteriorated as were evening and morning well-being, mood, affectivity and drowsiness. Noopsychic measures showed deteriorated numerical memory, fine motor activity and reaction time variability. In a placebo-controlled crossover design study, the acute effects of 100 mg trazodone¹, a serotonin reuptake inhibitor with a sedative action due to 5HT₂ and α₁ receptor blockade, were investigated in the patients. As compared with placebo, trazodone induced an increase in slow-wave sleep (S3 + 4), a lengthening of REM latency, a decrease in REM sleep and a normalization of the periodic leg movement (PLM) index. In the morning, there was a minimal increase in somatic complaints and a decrease in critical flicker frequency and systolic blood pressure. In conclusion, our study demonstrated that dysthymia induced significant changes in objective and subjective sleep and awakening quality, which were counteracted by 100 mg trazodone, thus suggesting a key-lock principle in the treatment of nonorganic insomnia related to dysthymia with this drug.

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“…Statistical analysis was based on the concept of descriptive data analysis as proposed by Abt et al [42] and by Ferber et al [43] for controlled clinical trials, concentrating on differences between the adaptation and placebo night as well as between the placebo and ropinirole night.…”

Section: Plm Indices Were Subdivided Into Plm/h Of Time In Bed (mentioning

confidence: 99%

Sleep Laboratory Studies in Restless Legs Syndrome Patients as Compared with Normals and Acute Effects of Ropinirole

et al. 2000

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The restless legs syndrome (RLS) is a common sensorimotor disorder which leads to severe sleep disturbances and showed a prevalence of 7.9% in our sleep laboratory. The aim of this study was to investigate periodic leg movements (PLM), arousal and respiratory variables in 12 untreated RLS patients and to measure the acute effects of 0.5 mg ropinirole, a nonergoline dopamine agonist, as compared with placebo. In the target variable PLM/h of total sleep time (PLM/h TST), RLS patients showed an increased value of 40/h (normal 0–5/h). Further, we found an increased number of PLM (368), PLM/h of time in bed (49/h), PLM/h of REM sleep (11), PLM/h of non-REM sleep (46) and PLM/h awake (61). The arousal index was also increased (32/h; normal 0–25/h), as were arousals due to PLM. In the confirmatory part of our descriptive data analysis, ropinirole 0.5 mg significantly improved, as compared with placebo, the index PLM/h TST by 75%. In the descriptive part, all the other PLM variables were improved as well. Arousals due to PLM decreased, while spontaneous arousals increased. Respiratory variables, which had a priori been in the normal range, showed a slight but significant improvement after the dopamine agonist. Thus, 0.5 mg ropinirole significantly improved the target variable PLM/h TST, along with objective and subjective sleep quality and morning noopsychic performance, as described in the preceding paper. Our data encourage further sleep studies including all above-mentioned variables in a larger group of RLS/PLM during sleep patients as well as long-term efficacy trials.

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IPEG Guideline on Statistical Design and Analysis for Pharmacodynamic Trials

Cited by 39 publications

References 19 publications

Guidelines for the Recording and Evaluation of Pharmaco-EEG Data in Man: The International Pharmaco-EEG Society (IPEG)

Guidelines for the Recording and Evaluation of Pharmaco-EEG Data in Man: The International Pharmaco-EEG Society (IPEG)

Insomnia Related to Dysthymia: Polysomnographic and Psychometric Comparison with Normal Controls and Acute Therapeutic Trials with Trazodone

Sleep Laboratory Studies in Restless Legs Syndrome Patients as Compared with Normals and Acute Effects of Ropinirole

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