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Journal Article 2007; 28(Suppl 1): 117-133 PubMed PMID: 17262004 Citation  Keywords:  Antipsychotic Agents:adverse effects, Bipolar Disorder:drug therapy, Clinical Trials as Topic, Humans, Long-Term Care, Quality of Life, Schizophrenia:drug therapy, Treatment Outcome,.   

: Health-related quality of life (QoL) represents important measure of treatment outcome in mental disorders. Numerous studies indicate that QoL of people with schizophrenia and bipolar disorder is similar to that of patients with chronic physical conditions. It has been shown that schizophrenia patients can themselves reliably assess their QoL; in addition to the objective scales various self-reporting instruments are used. Patients with bipolar disorder have QoL consistently higher than patients with schizophrenia and similar to that found in people with unipolar depression. Quality of life can be negatively affected by drug-induced side-effects and subjective treatment response. The second-generation antipsychotics (SGA) have superior efficacy on QoL over classical antipsychotics in approximately half of the studies with schizophrenia; in the other half those groups are comparable. However, in none of the trials novel antipsychotics were inferior. All SGA (clozapine, olanzapine, risperidone, amisulpride, quetiapine, ziprasidone, or remoxipride) have been found to be beneficial for patients well-being. The most investigated drugs that convincingly improve QoL in schizophrenia are olanzapine and risperidone (including depot form). Results of several studies indicate that individual antipsychotics may differ in their effects on QoL, with suggested superiority of olanzapine. In bipolar disorder, SGA consistently showed their superiority over placebo in effects on QoL. The most studied SGA in bipolar disorder is olanzapine. More long-term controlled double-blind trials are needed to definitively uphold superiority and different effects of individual SGA on QoL of patients with schizophrenia and bipolar disorder....

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Journal Article 2005; 26(Suppl 1): 49-65 PubMed PMID: 16361988 Citation  Keywords:  Antidepressive Agents, Second-Generation:administration & dosage, Antipsychotic Agents:administration & dosage, Bipolar Disorder:drug therapy, Clinical Trials as Topic, Humans, Treatment Outcome,.   

: Conventional antipsychotic drugs, although efficacious in the treatment of mania, have not demonstrated a significant usefulness in the maintenance treatment of bipolar disorder. This has primarily been due to a tendency to induce depressive symptoms and depressive recurrences in this group of patients in the course of long-term administration. However, the picture has changed following the introduction of second-generation antipsychotics. These drugs have pro-depressant properties (if any) that are much weaker than conventional antipsychotics. Furthermore, their tolerability, especially in long-term treatment, is more favorable compared to classical antipsychotics. Clinical observations of the action profile of second-generation antipsychotic drugs in the treatment of schizophrenia have pointed to a possibility of these agents possessing mood-stabilizing properties. The first such suggestion was made by Zarate (1995) in connection with clozapine. The prevention of manic and depressive recurrences in bipolar disorder is a hallmark of the definition of mood-stabilizers....

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Journal Article 2005; 26(Suppl 1): 27-47 PubMed PMID: 16361987 Citation  Keywords:  Antidepressive Agents, Second-Generation:therapeutic use, Antipsychotic Agents:therapeutic use, Bipolar Disorder:drug therapy, Clinical Trials as Topic, Depressive Disorder:diet therapy, Humans, Treatment Outcome,.   

: Antidepressants have insufficient effect in 20-40% of patients treated for depressive disorders. This is particularly true for psychotic and agitated depression. When administered on a long-term basis, antidepressants cause a switch into mania in 25-40% of patients and induce rapid cycling. Classical antipsychotics have exhibited good therapeutic efficacy in the treatment of various forms of depression, especially psychotic and agitated forms, albeit burdened with many, above all extrapyramidal, side effects. When administered over long periods of time, classical antipsychotics may have a depressogenic effect. Second-generation antipsychotics have started to be increasingly used in this indication for a variety of reasons including: their antidepressant effect attributable to raised concentrations of catecholamines in the prefrontal cortex, their impact on serotonin transmission, their antipsychotic effect due to their mode of action including the mesolimbic blockade of dopamine D2 receptors, and the low incidence of extrapyramidal and other side effects. The following text encompasses the results of controlled trials using second-generation antipsychotics in the treatment of acute depressive disorders....

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Journal Article 2002; 23(Suppl 1): 88-91 PubMed PMID: 12019359 Citation  Keywords:  Adult, Blood Pressure:drug effects, Circadian Rhythm:physiology, Clinical Trials as Topic, Electromagnetic Fields:adverse effects, Heart Rate:drug effects, Humans, Male, Melatonin:analogs & derivatives, Telephone,.   

OBJECTIVES: It is quite likely that non-visible electromagnetic fields (EMF) may affect melatonin production. Some studies confirmed this hypothesis and showed that extremely low EMF altered pineal function in animals and humans. Thus, it is reasonable to suppose that EMF emitted by cellular phones may also influence secretion of melatonin. The present study sought to evaluate possible effect of the exposure to EMF emitted by cellular phone on 6-hydroxymelatonin sulfate (6-OHMS) excretion, which reflects melatonin levels in blood.

MATERIAL AND METHODS: The examined group consisted of 9 healthy males aged 19-29 years. The experiment was performed under controlled conditions (the light intensity-50 lx till midnight and 0 lx during night). Each person was examined twice: on a day without exposure (control day, C-day) and on a day with continuous exposure (60 min. exposure from cellular phone, frequency 900 MHz, pulsed with 217 Hz, pulse with 576 micros, SAR 1.23 W/kg, E-day). From 7 p.m. to 8 p.m. they used a cellular phone. The subjects did not know which day was E-day, and which was C-day. From 8 p.m. till midnight the subjects listened to music and than they slept till 7 a.m. next day. Urine samples were collected at 7 p.m., at midnight, and at 7 a.m. in the same way in C-day as in E-day. Sample were frozen for later ELISA analysis of 6-OHMS. The 6-OHMS ELISA kit from Immuno-Biological Laboratories (Hamburg) was used for measurement of 6-OHMS. The data were analysed using Wilcoxon matched-pairs signed-ranks test for each subject and for the whole group. We compared 6-OHMS level on the E-day and on the C-day separately for 3 time-points - 7 p.m., midnight, 7 a.m.

RESULTS: Mean 6-OHMS level in both experiments did not differ significantly for any of the respective time points. Circadian variations of 6-OHMS level were detected in all subjects.

CONCLUSIONS: The results of our investigation has demonstrated that EMF emitted by cellular phones has no distinct influence on the melatonin level....

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Journal Article 2002; 23(Suppl 1): 30-38 PubMed PMID: 12019349 Citation  Keywords:  Antineoplastic Agents:therapeutic use, Antioxidants:metabolism, Clinical Trials as Topic, Humans, Melatonin:metabolism, Neoplasms:drug therapy, Pineal Gland:physiology,.   

: The aim of this article is provide a survey of the current knowledge relating to the analysis of melatonin and its administration to cancer patients. On the basis of this compilation of data it can be discussed under which conditions melatonin may be used for diagnostic and/or therapeutic purposes in clinical oncology. Melatonin is depressed in patients with cancers of different origins during the phase of primary tumour growth whereas a normal or sometimes elevated pineal melatonin secretory activity is found during early stages of tumour development or when recidivations arise. The clinical studies of Lissoni show that melatonin, particularly if combined with interleukin-2, is able to favourably influence the course of advanced malignant disease leading to a prolonged survival as well as to an improved quality of life. These findings require to be verified by independent and controlled replication studies. If they can be confirmed it should be attempted to administer melatonin to patients with earlier stages of cancer parallel to standard oncological treatment regimens. In such trials it should be tested whether a substitutional therapy in patients with endogenously depressed melatonin may favourably affect the course of the disease both in quantitative (inhibitory effect on tumour growth and spread) and qualitative terms (improved performance status)....

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Journal Article 2002; 23(Suppl 1): 20-23 PubMed PMID: 12019347 Citation  Keywords:  Aged, Alzheimer Disease:complications, Antioxidants:therapeutic use, Circadian Rhythm:drug effects, Clinical Trials as Topic, Humans, Melatonin:therapeutic use, Sleep Wake Disorders:drug therapy,.   

: About 45% of Alzheimer's disease (AD) patients have disruptions in their sleep and sundowning agitation. Since melatonin secretion is greatly inhibited in AD patients we have used melatonin to treat sleep disorders in AD patients since 1995. In a first study [21] we reported, in 7 out of 10 dementia patients treated with melatonin (3 mg p.o. at bed time), a decreased sundowning. In a second study [22] we examined 14 AD patients who received 9 mg melatonin daily for 22 to 35 months, observing a significant improvement of sleep quality with stabilization of behavioral and cognitive parameters. In a third study [23] we reported two monozygotic twins with AD and similar cognitive impairment, one of them receiving 6 mg melatonin at bedtime daily for 3 years. Melatonin treatment improved sleep quality and suppressed sundowning. We now report the effect of melatonin (4-month-long treatment with 6 mg/day) in 45 AD patients with sleep disturbances. Melatonin improved sleep and suppressed sundowning, an effect seen regardless of the concomitant medication employed to treat cognitive or behavioral signs of AD. Melatonin treatment seems to constitute a selection therapy to ameliorate sundowning and to slow evolution of cognitive impairment in AD patients....

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