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Journal Article 2010; 31(6): 801-806 PubMed PMID: 21196929 Citation  Keywords:  Adult, Antidepressive Agents:therapeutic use, Anxiety:drug therapy, Blood Glucose:metabolism, Blood Pressure:drug effects, Body Weight:drug effects, Depression:drug therapy, Diabetes Mellitus, Type 1:blood, Double-Blind Method, Female, Hemoglobin A, Glyco.   

OBJECTIVE: Depression is a common disorder among diabetic patients and affects negatively the treatment of their basic disease. The aim of the study was to assess, whether antidepressant medication could positively influence glycemic control of diabetes type 1 in depressive or anxious patients.

METHODS: A six-month, double-blinded, randomized, placebo-controlled study was performed to investigate the reaction of type 1diabetic patients (n=21) to treatment of depression and anxiety symptoms using antidepressant drug sertraline. The patients were given sertraline (100 mg/day) or placebo. The evolution of mental change was assessed using Zung Self-Rating Depression Scale (SDS), Hamilton Anxiety Rating Scale (HAMA) and Hamilton Depression Rating Scale (HAMD) along with development of somatic parameters commonly assessed in diabetic patients, especially glycosylated hemoglobin, insulin dose and body weight. The level of active substance in serum of the patients was also measured.

RESULTS: Mental state improved at the level of statistical significance of p<0.001 in both patients using antidepressant and placebo. From somatic parameters, body weight and systolic blood pressure increased statistically significantly also in both groups of patients.

CONCLUSIONS: The mental state of most patients who successfully completed the study improved regardless of the fact if they were using antidepressant or placebo. No statistically significant connections between the mental and somatic changes were found. This finding points out to the placebo effect of the medication, to the importance of a contact with patients, but also to the need to concentrate on their mental state....

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Journal Article 2007; 28(4): 360-366 PubMed PMID: 17693960 Citation  Keywords:  Bottle Feeding, Chronotherapy, Circadian Rhythm:physiology, Dietary Carbohydrates:administration & dosage, Double-Blind Method, Feeding Behavior:physiology, Humans, Infant, Infant Formula:administration & dosage, Infant, Newborn, Prospective Studies, Slee.   

UNLABELLED: Some 30% of pre-weaning infants present problems of sleep during the night, especially those who are bottle-fed. The solution is for them to be breast-fed for as long as possible, or, if this is not possible, for the formula milk to reproduce breast-milk's natural circadian variations in the concentrations of tryptophan and those nucleotides which have a beneficial effect in consolidating the circadian sleep-wake cycle.

OBJECTIVE: To study in pre-weaning infants the effect on nocturnal sleep of the administration of formula milk dissociated into its day/night components.

MATERIALS AND METHODS: A prospective study was carried out on 30 pre-weaning infants of 4-20 weeks in age who preferentially showed sleep problems. The day dissociated formula, administered from 06:00-18:00, had lower levels of tryptophan and carbohydrates, and higher levels of proteins together with cytosine-5P, guanosine-5P, and inosine-5P. The night dissociated formula, administered from 18:00-06:00, had lower levels of proteins and medium-chain triglycerides, higher levels of tryptophan and carbohydrates, together with adenosine-5P and uridine-5P. In a random, double-blind, design, three one-week diets were administered: Diet A (Control): normal initiation milk; Diet B: 06:00-18:00 normal initiation milk, 18:00-06:00 dissociated night formula; and Diet C: day/night formulas with the schedule given above. The sleep patterns were analyzed by means of actimeters (Actiwatch). Statistical analysis consisted of an ANOVA with a Scheffe F-test, taking a value of p<0.05 to be statistically significant.

RESULTS: The children receiving the week of Diet C (with the day/night formulas in synchrony with the environment) showed increased hours of actual sleep (7.68 +/- 0.54 h vs. 6.77 +/- 0.12 h for the Diet A control) and improved sleep latency (0.44 +/- 0.04 h vs. 0.60 +/- 0.08 h for the Diet A control). The same children receiving the Diet B in another different week showed an improvement in sleep efficiency (76.43 +/- 3.4% vs. the Diet A control 69.86 +/- 0.94%) and sleep latency (0.45 +/- 0.04 h vs. the Diet A control 0.60 +/- 0.08h) The parents also reported, in response to follow-up questions, an improvement in the sleep of their infants during the Diet C week.

CONCLUSION: Day/night infant formula milks designed according to the principles of chrononutrition help to consolidate the sleep/wake rhythm in bottle-fed infants....

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Journal Article 2007; 28(1): 33-38 PubMed PMID: 17277734 Citation  Keywords:  Adult, Antidepressive Agents:therapeutic use, Anxiety:physiopathology, Combined Modality Therapy, Double-Blind Method, Female, Humans, Male, Middle Aged, Panic Disorder:physiopathology, Prefrontal Cortex:physiopathology, Serotonin Uptake Inhibitors:therap.   

BACKGROUND: Transcranial magnetic stimulation (rTMS) can modulate cortical activity. The goal of our study was to assess whether rTMS would facilitate effect of serotonin reuptake inhibitors in patients with panic disorder.

METHOD: Fifteen patients suffering from panic disorder resistant to serotonin reuptake inhibitor (SRI) therapy were randomly assigned to either active or to sham rTMS. The aim of the study was to compare the 2 and 4 weeks efficacy of the 10 sessions 1 Hz rTMS with sham rTMS add on SRI therapy. We use 1 Hz, 30 minutes rTMS, 110% of motor threshold administered over the right dorso-lateral prefrontal cortex (DLPFC). The same time schedule was used for sham administration. Fifteen patients finished the study,. Psychopathology was assessed using the rating scales CGI, HAMA, PDSS and BAI before the treatment, immediately after the experimental treatment and 2 weeks after the experimental treatment by an independent reviewer.

RESULTS: Both groups improved during the study period but the treatment effect did not differ between groups in any of the instruments.

CONCLUSION: Low frequency rTMS administered over the right dorso-lateral prefrontal cortex after 10 sessions did not differ from sham rTMS add on serotonin reuptake inhibitors in patients with panic disorder....

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Journal Article 2007; 28(Suppl 1): 49-70 PubMed PMID: 17262007 Citation  Keywords:  Antipsychotic Agents:therapeutic use, Double-Blind Method, Humans, Placebos, Randomized Controlled Trials as Topic, Recurrence, Research Design, Schizophrenia:drug therapy, Treatment Outcome,.   

: Fourteen long-term (duration at least 26 months) double-blind, randomized studies comparing second-generation antipsychotics (SGAs) with placebo, conventional antipsychotics, or two or more SGAs, published after 2002 have been reviewed and are summarized in this chapter. Methodological problems and factors influencing results such as patient populations involved, outcome criteria, and dosages of evaluated drugs are discussed....

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Controlled Clinical Trial 2006; 27(3): 373-380 PubMed PMID: 16816833 Citation  Keywords:  Bottle Feeding, Chronobiology Phenomena:physiology, Circadian Rhythm:physiology, Double-Blind Method, Feeding Behavior:physiology, Female, Humans, Infant, Infant Formula:pharmacology, Infant Nutritional Physiological Phenomena, Infant, Newborn, Male, Nucl.   

: On the basis of the circadian nutritional variations present in breast milk, and of the implications for the sleep/wake cycle of the nutrients present in infant formula milks, we designed a formula milk nutritionally dissociated into a Day/Night composition. The goal was to improve the bottle-fed infant's sleep/wake circadian rhythm. A total of 21 infants aged 4-20 weeks with sleeping difficulties were enrolled in the three-week duration study. The sleep analysis was performed using an actimeter (Actiwatch) placed on an ankle of each infant to uninterruptedly record movements during the three weeks. The dissociated Day milk, designed to be administered from 06:00 to 18:00, contained low levels of tryptophan (1.5g/100g protein) and carbohydrates, high levels of proteins, and the nucleotides Cytidine 5 monophosphate, Guanosine 5 monophosphate and Inosine 5 monophosphate. The dissociated Night milk, designed to be administered from 18.00 to 06.00, contained high levels of tryptophan (3.4g/100g protein) and carbohydrates, low levels of protein, and the nucleotides Adenosine 5 monophosphate and Uridine 5 monophosphate. Three different milk-feeding experiments were performed in a double-blind procedure covering three weeks. In week 1 (control), the infants received both by day and by night a standard formula milk; in week 2 (inverse control), they received the dissociated milk inversely (Night/Day instead of Day/Night); and in week 3, they received the Day/Night dissociated formula concordant with the formula design. When the infants were receiving the Day/Night dissociated milk in concordance with their environment, they showed improvement in all the nocturnal sleep parameters analyzed: total hours of sleep, sleep efficiency, minutes of nocturnal immobility, nocturnal awakenings, and sleep latency. In conclusion, the use of a chronobiologically adjusted infant formula milk seems to be effective in improving the consolidation of the circadian sleep/wake cycle in bottle-fed infants....

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Journal Article 2006; 27(3): 327-332 PubMed PMID: 16816829 Citation  Keywords:  Adult, Antidepressive Agents, Second-Generation:therapeutic use, Combined Modality Therapy, Double-Blind Method, Drug Resistance, Electric Stimulation Therapy:methods, Female, Humans, Male, Neuropsychological Tests, Obsessive-Compulsive Disorder:therapy, .   

BACKGROUND: The goal of our study is to assess whether transcranial magnetic stimulation (rTMS) would facilitate the effect of antidepressant in OCD patients.

METHOD: The aim of the randomized, double-blind, sham controlled study was to compare the 2 and 4 week efficacy of the 10 sessions rTMS with sham rTMS in serotonin reuptake inhibitor resistant OCD patient. Thirty three right-handed patients were randomly assigned to either active rTMS or to sham rTMS. Active rTMS with the frequency of 1 Hz at 110% of motor threshold (MT) was administered over the left dorso-lateral prefrontal cortex. The same time schedule was used for sham administration. Thirty patients finished the study, three patients' dropped out at the beginning. Psychopathology was assessed by CGI, HAMA, Y-BOCS and BAI before the treatment, immediately after the experimental treatment, and 2 weeks after the experimental treatment by an independent reviewer.

RESULTS: Both groups improved during the study period but the treatment effect did not differ between them in any of the instruments.

CONCLUSION: Low frequency rTMS administered over the left dorso-lateral prefrontal cortex during 10 daily sessions did not differ from sham rTMS in facilitating the effect of serotonin reuptake inhibitors in OCD patients....

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Journal Article 2006; 27(1-2): 209-213 PubMed PMID: 16648775 Citation  Keywords:  Adult, Double-Blind Method, Female, Humans, Male, Neuropsychological Tests, Psychiatric Status Rating Scales, Schizophrenia:therapy, Schizophrenic Psychology, Transcranial Magnetic Stimulation,.   

: The high-frequency repetitive transcranial magnetic stimulation (HF-rTMS) over the prefrontal cortex is a promising method for the treatment of negative symptoms of schizophrenia. Using double-blind sham-controlled parallel design, we evaluated the effect of HF-rTMS over the left dorsolateral prefrontal cortex (DLPFC) on negative symptoms in patients with schizophrenia. Sixteen schizophrenia patients with predominantly negative symptoms on stable antipsychotic medication were treated with 20 Hz rTMS (90% of motor threshold, 2000 stimuli per session) over ten days within 2 weeks with six weeks follow-up. The effect was assessed using PANSS, CGI, MADRS and neuropsychological tests. We failed to find any significant effect of active rTMS. Sham rTMS showed a trend for improvement over time on positive and negative subscales of PANSS and MADRS. Between-group comparisons failed to reveal any significant differences on any rating scales except a positive subscale of PANSS after 8 weeks. Results from our study did not confirm that HF-rTMS over the left DLPCF affects the negative symptoms of schizophrenia and alternative rTMS approaches are discussed....

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Comment 2005; 26(6): 757-758 PubMed PMID: 16380670 Citation  Keywords:  Circadian Rhythm:drug effects, Diabetes Mellitus, Type 2:blood, Double-Blind Method, Humans, Hydrocortisone:blood, Hypoglycemic Agents:pharmacology, Hypothalamo-Hypophyseal System:drug effects, PPAR gamma:agonists, Pituitary-Adrenal System:drug effects, T.   

OBJECTIVES: PPAR-gamma agonists are able to inhibit pituitary tumour development and tumoral hormonal secretion in rodents both in vitro and in vivo. Their use for treatment of Cushing Disease (CD) has been suggested but the clinical experience with the two PPAR-gamma agonists commercially available (rosiglitazone and pioglitazone) was not impressive. Short-time treatment has been proposed to be the cause of unsuccessful results on CD in humans. We report here the effect on early-morning plasma cortisol levels of a long-time treatment with rosiglitazone at the highest approved dose.

METHODS: Because PPAR-gamma receptors are located in normal corticotroph cells we tested in a placebo-controlled study the influence of rosiglitazone on cortisol secretion. The study enrolled 30 newly diagnosed type 2 patients which were assigned to receive either rosiglitazone (8 mg/day) or placebo. Plasma morning cortisol (8.00 a.m.) was measured at the baseline and at the end of the study.

RESULTS: Rosiglitazone vs placebo did not modify the early morning plasma levels of cortisol (13 microg/dl [3-21] vs 11 microg/dl [7-23] [median and range]) after 26 weeks of treatment.

CONCLUSION: The discrepancy between in vitro and animal data on one side and clinical data on the other side warrant further investigations into the mechanisms of action of PPAR-gamma agonists on ACTH secretion before other clinical studies will be conducted....

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