Prophylactic Effects of Agomelatine for Poststroke Depression

Status Not yet recruiting

Clinical Trial Summary

The incidence of depression in stroke patients with frontal lobe involvement was reported to be as high as 42%. Agomelatin, a type 1/2 melatonin receptor agonist and serotonin 2C receptor antagonist, is effective in treatment of depression, but whether it can prevent poststroke depression (PSD) remains unknown. The PRAISED trial is a multicenter, randomized, double-blind trial and is designed to evaluate the efficacy and safety of agomelatine in the prevention of PSD in stroke patients with frontal lobe involvement. The primary outcome is the rate of post-stroke depression for 180 days.

Clinical Trial Description

This PRAISED trial is a multicenter, randomized, double-blind trial to evaluate the efficacy and safety of agomelatine in the prevention of PSD in patients with acute ischemic stroke. The sample size is 420. The participants will be randomized to receive a 6-month treatment of agomelatine 25mg/d or placebo 25mg/d. The primary end point is the proportion of PSD within 180 days. PSD is defined as the Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by the Diagnostic and Statistical Manual of mental disorders-V (DSM-V). The second end point are rate of recurrence of ischemic stroke within 90 days, modified Rankin Scale (mRS), National Institutes of Health Stroke Scale (NIHSS), vascular death, transient ischemic attack (TIA)/stroke or myocardial infarction during the 6-months, cognitive function(Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Epworth Sleepiness Scale (ESS), Stroke Specific Quality Of Life (SS-QOL) scale, adherence to medication, adverse events. The study consists of five visits including the day of randomization, day 14±3 days, day 28±3 days, day 90±7 days, day 180±7 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05426304
Study type	Interventional
Source	First Affiliated Hospital, Sun Yat-Sen University
Contact	Jinsheng Zeng
Phone	13322800657
Email	zengjs@pub.guangzhou.gd.cn
Status	Not yet recruiting
Phase	Phase 4
Start date	October 1, 2022
Completion date	May 31, 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05777044` - The Effect of Hatha Yoga on Mental Health	N/A
Recruiting	`NCT04977232` - Adjunctive Game Intervention for Anhedonia in MDD Patients	N/A
Recruiting	`NCT04680611` - Severe Asthma, MepolizumaB and Affect: SAMBA Study
Recruiting	`NCT04043052` - Mobile Technologies and Post-stroke Depression	N/A
Completed	`NCT04512768` - Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy	N/A
Recruiting	`NCT03207828` - Testing Interventions for Patients With Fibromyalgia and Depression	N/A
Completed	`NCT04617015` - Defining and Treating Depression-related Asthma	Early Phase 1
Recruiting	`NCT06011681` - The Rapid Diagnosis of MCI and Depression in Patients Ages 60 and Over
Completed	`NCT04476446` - An Expanded Access Protocol for Esketamine Treatment in Participants With Treatment Resistant Depression (TRD) Who do Not Have Other Treatment Alternatives	Phase 3
Recruiting	`NCT02783430` - Evaluation of the Initial Prescription of Ketamine and Milnacipran in Depression in Patients With a Progressive Disease	Phase 2/Phase 3
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT04598165` - Mobile WACh NEO: Mobile Solutions for Neonatal Health and Maternal Support	N/A
Completed	`NCT03457714` - Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
Recruiting	`NCT05956912` - Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
Completed	`NCT05588622` - Meru Health Program for Cancer Patients With Depression and Anxiety	N/A
Recruiting	`NCT05234476` - Behavioral Activation Plus Savoring for University Students	N/A
Active, not recruiting	`NCT05006976` - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study	N/A
Enrolling by invitation	`NCT03276585` - Night in Japan Home Sleep Monitoring Study
Terminated	`NCT03275571` - HIV, Computerized Depression Therapy & Cognition	N/A
Completed	`NCT03167372` - Pilot Comparison of N-of-1 Trials of Light Therapy	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Prophylactic Effects of Agomelatine for Poststroke Depression — PRAISED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms