A single-site, double-blind, placebo-controlled, dose-ranging study of YKP10A--a putative, new antidepressant
| Autor: | David J. Brunswick, Jay D. Amsterdam, Miriam Hundert |
|---|---|
| Rok vydání: | 2002 |
| Předmět: |
Adult
Male medicine.medical_specialty Phenylalanine Administration Oral Anxiety Placebo Severity of Illness Index law.invention Placebos Randomized controlled trial Double-Blind Method law Internal medicine Sleep Initiation and Maintenance Disorders Severity of illness medicine Humans Psychiatry Adverse effect Biological Psychiatry Depression (differential diagnoses) Pharmacology Depressive Disorder Dose-Response Relationship Drug Headache Middle Aged Dose-ranging study Antidepressive Agents Clinical trial Treatment Outcome Antidepressant Female Psychology Digestive System |
| Zdroj: | Progress in neuro-psychopharmacologybiological psychiatry. 26(7-8) |
| ISSN: | 0278-5846 |
| Popis: | Background: YKP10A is a novel, new antidepressant that may affect dopamine neurotransmission. We present results from the first Phase II clinical trial of YKP10A antidepressant activity in patients with major depression. Methods: This was a single-site, placebo-controlled, dose-ranging study. Patients with major depression were randomly assigned to one of four double-blind treatment conditions: YKP10A 100–300 mg/day, YKP10A 400–600 mg/day, YKP10A 700–900 mg/day, or placebo for 8 weeks. Results: 43 patients were screened and 35 were randomized. Nineteen patients (54.3%) completed the entire 8-week study. Five YKP10A-treated patients (19%) discontinued treatment for adverse events. Thirty-eight percent of patients in the medium dose YKP10A group had a reduction in baseline HAM-D17 score ≥50% compared with the low-dose (13%), high-dose (13%), and placebo (29%) groups. A similar nonsignificant ‘signal’ for therapeutic activity was also seen in the medium-dose YKP10A group on the HAM-D 28 and the Montgomery–Asberg Depression Rating Scale (MADRS). Headaches, nervousness, agitation, insomnia, and gastrointestinal complaints were the most commonly reported side effects. Two cases of hypomania were observed. Limitations: This preliminary, single-site study was not powered to detect a statistically significant difference from placebo among treatment groups. Conclusion: YKP10A may have antidepressant activity at a daily dose range of 400–600 mg. |
| Databáze: | OpenAIRE |
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