142
Participants
Start Date
May 16, 2017
Primary Completion Date
August 9, 2018
Study Completion Date
August 9, 2018
Trazodone 20 mg
"Oral administration of trazodone 20 mg (corresponding to 10 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 60 mg.~After the 8-week treatment period, patients will receive trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution) three times a day for 1-week tapering period in double blind conditions."
Trazodone 10 mg
"Oral administration of trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 30 mg.~In order to maintain the study double-blind conditions,patients randomized in this group will be co-administered with placebo oral solution (5 drops).~After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions."
Placebo
"Oral administration of placebo oral solution (10 drops) three times a day, for 8-week treatment.~After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions."
Budai Irgalmasrendi Korhaz Belgyógyászati Centrum, Budapest
Semmelweis Egyetem AOK I. sz. Belgyogyaszati Klinika, Budapest
Markhot Ferenc Oktatokorhaz es Rendelointezet Diabetesz Gondozo, Eger
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz I. sz. Belgyogyaszati Osztaly, Gyula
Bacs-Kiskun Megyei Korhaz II. sz. Belgyogyaszati Osztaly, Kecskemét
Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Sz. Belgyogyaszati Klinika, Szeged
NEUROHK s.r.o., Choceň
Litnea s.r.o. Neurologicka ambulance, Litoměřice
Neurosanatio s.r.o., Litomyšl
MP-neuro s.r.o. Poliklinika Modry pavilon, Ostrava
Nemocnice Pardubickeho kraje a.s. Pardubicka nemocnice Neurologická klinika, Pardubice
Diabetologicka ambulance Milan Kvapil s.r.o., Prague
Vestra Clinics s.r.o., Rychnov Nad Knežnou
Silmedic Sp. z o.o., Katowice
Pro Familia Altera Sp. z o.o., Katowice
NZOZ Neuromed M. i M. Nastaj Sp. P., Lublin
RCMed Oddział Sochaczew, Sochaczew
"Jeka Sławomir Niepubliczny Zakład Opieki Zdrowotnej Nasz Lekarz Praktyka Grupowa Lekarzy Rodzinnych z Przychodnia Specjalistyczna", Torun
NBR Polska Tomasz Klodawski, Warsaw
Medycyna Kliniczna, Warsaw
Collaborators (1)
Chiltern International Inc.
INDUSTRY
Aziende Chimiche Riunite Angelini Francesco S.p.A
INDUSTRY