St. John’s wort extract LI160 for the treatment of depression with atypical features – A double-blind, randomized, and placebo-controlled trial
| Autor: | Ulrich Schmidt, Michael Ploch, Ulrike Kuhn, Harald Murck, Marcus Mannel |
|---|---|
| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Adolescent Population Placebo-controlled study Placebo Statistics Nonparametric law.invention Young Adult Double-Blind Method Randomized controlled trial law Statistical significance Internal medicine mental disorders medicine Humans education Psychiatry Atypical depression Biological Psychiatry Aged Psychiatric Status Rating Scales Depressive Disorder education.field_of_study Depression Plant Extracts Middle Aged medicine.disease Antidepressive Agents Patient Health Questionnaire Psychiatry and Mental health Clinical Global Impression Female Psychology Hypericum |
| Zdroj: | Journal of Psychiatric Research. 44:760-767 |
| ISSN: | 0022-3956 |
| Popis: | Preliminary data suggest that hypericum extract LI160 is effective in atypical depression. Reported is the outcome of an 8-week double-blind, placebo-controlled, randomized trial of 600 mg LI160 vs. placebo in patients with vegetative features of atypical depression, i.e. hyperphagia or hypersomnia. One-hundred (100) patients with mild and 100 patients with moderate severity of a major depression according to ICD-10 were randomized. Patients needed to meet a score of 2 in at least one of the items 22-26 of the Hamilton-Depression-Rating-Scale (HAM-D) 28-item version and episode duration of at least 3 months. The primary outcome variable was the relative change of the HAM-D(17) from Baseline. Secondary outcome variables were the depression sub-score of the Patient Health Questionnaire (PHQ-9), the Clinical Global Impression (CGI), a patient's satisfaction scale, the Hamilton-Anxiety-Scale (HAM-A) and the sum score of atypical vegetative symptoms of the HAM-D(28). The percentage reduction of the HAM-D(17) for LI160 compared to placebo approached statistical significance (p=0.051) in the Full Analysis Set (FAS)-population. Using the conventional criterion of the absolute reduction of the HAM-D(17) significance was achieved (p |
| Databáze: | OpenAIRE |
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