Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia (Morfeu)
National, Phase II/III, Multicenter, Randomized, Double-blind, Controlled, Parallel,Effect of Melatonin 3mg and 5mg Plus Cognitive Behavioral Therapy for Insomnia (CBT-I) Compared to the CBT-I Alone in the Treatment of Insomnia Disorder
Sponsor: Ache Laboratorios Farmaceuticos S.A.
This PHASE2/PHASE3 trial investigates Insomnia Disorder and is currently ongoing. Ache Laboratorios Farmaceuticos S.A. leads this study, which shows 10 recorded versions since 2018 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
10 versions recorded-
Sep 2024 — Present [monthly]
Unknown PHASE2/PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2/PHASE3
Status: Unknown Status → Unknown · Phase: PHASE2_PHASE3 → PHASE2/PHASE3
-
Nov 2022 — Jul 2024 [monthly]
Unknown Status PHASE2_PHASE3
Status: Recruiting → Unknown Status
-
Jan 2021 — Nov 2022 [monthly]
Recruiting PHASE2_PHASE3
-
Oct 2020 — Jan 2021 [monthly]
Recruiting PHASE2_PHASE3
▶ Show 5 earlier versions
-
Feb 2020 — Oct 2020 [monthly]
Recruiting PHASE2_PHASE3
-
Dec 2018 — Feb 2020 [monthly]
Recruiting PHASE2_PHASE3
Status: Not Yet Recruiting → Recruiting
-
Jun 2018 — Dec 2018 [monthly]
Not Yet Recruiting PHASE2_PHASE3
-
Feb 2017 — Jun 2018 [monthly]
Not Yet Recruiting PHASE2_PHASE3
-
Jan 2017 — Feb 2017 [monthly]
Not Yet Recruiting PHASE2_PHASE3
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Ache Laboratorios Farmaceuticos S.A.
For direct contact, visit the study record on ClinicalTrials.gov .