A Placebo Controlled Trial on Add-on Modafinil on the Anti-psychotic Treatment Emergent Hyperglycemia and Hyperlipidemia

Abstract

Modafinil is non stimulant drug which is marketed for mainly Narcolepsy and daytime drowsiness. The clinical experience and Summary of Product Characteristics (SPC) of the drug also mentions Anorexia as one of the side effects. Anorexia can have a direct impact on the carbohydrate and fat intake, which may, in turn, regulate antipsychotic induced dyslipidemia and Hyperglycaemia.Aim:To compare the effects of Modafinil- ADDON with Placebo add on with olanzapine, Clozapine and Risperidone in drug naive subjects and people who were started on the drugs within 15days of assessment.Materials and Methods:Randomized, Double blind, Placebo controlled study, which was conducted at two centres, one at department of Psychiatry, S.V Medical College, Tirupati and the other at Asha hospitals, Hyderabad. Seventy two patient were randomised, sixty three patients have completed the total study period of three months. The dose of Modafinil was 200 mgs constantly as Flexible doses of Olanzapine, Clozapine and Risperidone as per clinical need was given. A baseline, three week and twelve week assessments of Fasting blood Glucose and fasting Serum cholesterol were made and the groups were compared on these parameters.Results:From baseline to week 3 there was a significant raise in Fasting serum cholesterol followed by a fall from week 3 to week 12 in the Modafinil addon group, though it could not be considered a drug for hypercholesteremia like Statins in controlling hyperlipidaemia. The implications of these findings were discussed.

Modafinil Augmentation of Atypical Antipsychotic Agents: Duplicate Publication, Self-plagiarism, Salami Publication, and Other Matters

“…We were surprised that the paper contained no data at all and that only one reference was cited in the bibliography. A little further investigation revealed that the paper bears striking similarities to two earlier publications[ 2 3 ] in the same journal; in fact, the present paper[ 1 ] appears to have been extracted almost verbatim from the original publication[ 2 ] with all references to the metabolic effects of atypical antipsychotics, and the effect of modafinil on weight removed for the creation of the present paper. [ 1 ] There is also extensive verbatim content overlap among the three papers.…”

“…[ 1 ] There is also extensive verbatim content overlap among the three papers. [ 1 2 3 ] Finally, all three papers describe the same study with only minor changes in outcome measures. In other words, the publication of these three papers constitutes duplicate publication, self-plagiarism, and salami publication, all of which violate publication ethics.…”

“…These two CYP enzymes are responsible for the metabolism of almost all the atypical antipsychotic drugs including the 3 drugs risperidone, olanzapine, and clozapine, which the patients received in the described study. [ 1 2 3 ] Physicians consequently need to be aware of the risk of relapse into psychosis as a delayed drug interaction between modafinil/armodafinil and atypical antipsychotics. [ 7 8 ] It would have helped had the authors included the assessment of efficacy among their outcome measures because attenuation of negative symptom burden and worsening of psychosis have both been examined in this regard.…”

“…On a parting note: The papers[ 1 2 3 ] declare no support or conflict of interest, but their text refers to unblinding of medication by the sponsors. Perhaps, this was an oversight on the part of the authors.…”

“…Perhaps, this was an oversight on the part of the authors. We realize that the authors of the papers[ 1 2 3 ] and the editors of the journal will view our letter with consternation and chagrin, and we hope that they will take our submission constructively. This letter was prepared as a group activity by E-Journal Club (eJCIndia),[ 10 ] an educational initiative for postgraduate students and academic faculty, launched by the Task Forces on Psychopharmacology and the Task Force on Workshops and Training, Indian Psychiatric Society, and the Department of Psychopharmacology, National Institute of Mental Health and Neurosciences, Bengaluru.…”