Prophylactic Effects of Agomelatine for Poststroke Depression

NCT05426304 | Unknown Phase 4

• 1 other identifier: PRAISED
• Study Type: interventional
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Depression; Acute Ischemic Stroke

Keywords

poststroke depression, prevention, agomelatine

Outcome Measures

Primary Outcomes (1)

• rate of PSD within 180 days

  PSD is defined as Hamilton Depression Rating Scale-17 (HAMD-17) ≥7 or diagnosis of depression by DSM-V.

  180 days

Secondary Outcomes (14)

• rate of recurrence of ischemic stroke within 90 days

  90±7 days

• variation of HAMD-17 score from baseline

  14±3 days, 28±3 days, 90±7 days, and 180±7 days

• rate of sleep disorder

  180 days

• variation of Pittsburgh Sleep Quality Index (PSQI) score from baseline

  14±3 days, 28±3 days, 90±7 days and 180±7 days

• variation of Stroke Specific Quality of Life (SS-QOL) score from baseline

  28±3 days, 90±7 days, and 180±7 days

Study Arms (2)

Agomelatine

EXPERIMENTAL

The Agomelatine group will be received agomelatine (25 mg/day) for 180 days.

Drug: Agomelatine

Placebo

PLACEBO COMPARATOR

The Placebo group will be received placebo (25 mg/day) for 180 days.

Drug: Placebo Tablets

Interventions

Agomelatine DRUG

agomelatine 25 mg/day for 180 days

Also known as: Agomelatine Tablets

Agomelatine

Placebo Tablets DRUG

placebo 25 mg/day for 180 days

Also known as: Placebo Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged 18\~75 years;
• within 7 days after stroke onset;
• CT or MRI showed lesions involving the frontal lobe;
• mRS≤2 before onset for recurrent ischemic stroke;
• HAMD-17\<8 before enrollment;
• NIHSS\<16;
• be consious and able to complete the relevant assessment scales.

You may not qualify if:

• hemorrhagic stroke;
• with major depressive disorder, or have taken antidepressants within 30 days before stroke onset, or HAMD-17 ≥8;
• with other mental illnesses;
• history of drug abuse or alcohol dependence in the past 1 year
• with life-threatening illnesses or disorders which may affect the completion of the relevant assessment scale (e.g., hearing, language, visual impairment, etc.)
• with cognitive impairment who cannot complete the relevant assessment scale
• with serious neurodegeneration diseases (such as Parkinson's disease, Alzheimer's disease, etc.)
• infection or carriers of hepatitis B virus (HBV) or hepatitis C virus (HCV)
• serum ALT level ≥ 2 times of the upper limit of the reference interval or TBIL level \> 1.5 times of the upper limit of the reference interval
• renal dysfunction (creatinine clearance \< 90 ml/min/1.73 m2)
• allergic to or contra-indicated to agomelatine
• lactose intolerance
• pregnant or breast-feeding women
• withdraw from other clinical trials within 4 weeks or participating in other clinical trials

Sponsors & Collaborators

• First Affiliated Hospital, Sun Yat-Sen University: lead

Related Publications (17)

• Zhao FY, Yue YY, Li L, Lang SY, Wang MW, Du XD, Deng YL, Wu AQ, Yuan YG. Clinical practice guidelines for post-stroke depression in China. Braz J Psychiatry. 2018 Jul-Sep;40(3):325-334. doi: 10.1590/1516-4446-2017-2343. Epub 2018 Feb 1.

  PMID: 29412338 BACKGROUND

• Hackett ML, Pickles K. Part I: frequency of depression after stroke: an updated systematic review and meta-analysis of observational studies. Int J Stroke. 2014 Dec;9(8):1017-25. doi: 10.1111/ijs.12357. Epub 2014 Aug 12.

  PMID: 25117911 BACKGROUND

• Robinson RG, Jorge RE. Post-Stroke Depression: A Review. Am J Psychiatry. 2016 Mar 1;173(3):221-31. doi: 10.1176/appi.ajp.2015.15030363. Epub 2015 Dec 18.

  PMID: 26684921 BACKGROUND

• Villa RF, Ferrari F, Moretti A. Post-stroke depression: Mechanisms and pharmacological treatment. Pharmacol Ther. 2018 Apr;184:131-144. doi: 10.1016/j.pharmthera.2017.11.005. Epub 2017 Nov 9.

  PMID: 29128343 BACKGROUND

• Feng C, Fang M, Liu XY. The neurobiological pathogenesis of poststroke depression. ScientificWorldJournal. 2014 Mar 4;2014:521349. doi: 10.1155/2014/521349. eCollection 2014.

  PMID: 24744682 BACKGROUND

• Gu J, Huang H, Chen K, Huang G, Huang Y, Xu H. Are they necessary? Preventive therapies for post-stroke depression: A meta-analysis of RCTs. Psychiatry Res. 2020 Feb;284:112670. doi: 10.1016/j.psychres.2019.112670. Epub 2019 Oct 31.

  PMID: 31740211 BACKGROUND

• Kim JS, Lee EJ, Chang DI, Park JH, Ahn SH, Cha JK, Heo JH, Sohn SI, Lee BC, Kim DE, Kim HY, Kim S, Kwon DY, Kim J, Seo WK, Lee J, Park SW, Koh SH, Kim JY, Choi-Kwon S; EMOTION investigators. Efficacy of early administration of escitalopram on depressive and emotional symptoms and neurological dysfunction after stroke: a multicentre, double-blind, randomised, placebo-controlled study. Lancet Psychiatry. 2017 Jan;4(1):33-41. doi: 10.1016/S2215-0366(16)30417-5.

  PMID: 28012485 BACKGROUND

• FOCUS Trial Collaboration. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. Lancet. 2019 Jan 19;393(10168):265-274. doi: 10.1016/S0140-6736(18)32823-X. Epub 2018 Dec 5.

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  PMID: 17303771 BACKGROUND

• Robinson RG, Jorge RE, Moser DJ, Acion L, Solodkin A, Small SL, Fonzetti P, Hegel M, Arndt S. Escitalopram and problem-solving therapy for prevention of poststroke depression: a randomized controlled trial. JAMA. 2008 May 28;299(20):2391-400. doi: 10.1001/jama.299.20.2391.

  PMID: 18505948 BACKGROUND

• Almeida OP, Waterreus A, Hankey GJ. Preventing depression after stroke: Results from a randomized placebo-controlled trial. J Clin Psychiatry. 2006 Jul;67(7):1104-9. doi: 10.4088/jcp.v67n0713.

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• Chollet F, Tardy J, Albucher JF, Thalamas C, Berard E, Lamy C, Bejot Y, Deltour S, Jaillard A, Niclot P, Guillon B, Moulin T, Marque P, Pariente J, Arnaud C, Loubinoux I. Fluoxetine for motor recovery after acute ischaemic stroke (FLAME): a randomised placebo-controlled trial. Lancet Neurol. 2011 Feb;10(2):123-30. doi: 10.1016/S1474-4422(10)70314-8. Epub 2011 Jan 7.

  PMID: 21216670 BACKGROUND

• Tsai CS, Wu CL, Chou SY, Tsang HY, Hung TH, Su JA. Prevention of poststroke depression with milnacipran in patients with acute ischemic stroke: a double-blind randomized placebo-controlled trial. Int Clin Psychopharmacol. 2011 Sep;26(5):263-7. doi: 10.1097/YIC.0b013e32834a5c64.

  PMID: 21811172 BACKGROUND

• Niedermaier N, Bohrer E, Schulte K, Schlattmann P, Heuser I. Prevention and treatment of poststroke depression with mirtazapine in patients with acute stroke. J Clin Psychiatry. 2004 Dec;65(12):1619-23. doi: 10.4088/jcp.v65n1206.

  PMID: 15641866 BACKGROUND

• Berg A, Palomaki H, Lehtihalmes M, Lonnqvist J, Kaste M. Poststroke depression: an 18-month follow-up. Stroke. 2003 Jan;34(1):138-43. doi: 10.1161/01.str.0000048149.84268.07.

  PMID: 12511765 BACKGROUND

• Quera-Salva MA, Lemoine P, Guilleminault C. Impact of the novel antidepressant agomelatine on disturbed sleep-wake cycles in depressed patients. Hum Psychopharmacol. 2010 Apr;25(3):222-9. doi: 10.1002/hup.1112.

  PMID: 20373473 BACKGROUND

• Chern CM, Liao JF, Wang YH, Shen YC. Melatonin ameliorates neural function by promoting endogenous neurogenesis through the MT2 melatonin receptor in ischemic-stroke mice. Free Radic Biol Med. 2012 May 1;52(9):1634-47. doi: 10.1016/j.freeradbiomed.2012.01.030. Epub 2012 Feb 10.

  PMID: 22330064 BACKGROUND

MeSH Terms

Conditions

Depression; Ischemic Stroke

Interventions

agomelatine; Placebo Effect

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Effect Modifier, Epidemiologic; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jinsheng Zeng

  First Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Jinsheng Zeng

CONTACT

13322800657; zengjs@pub.guangzhou.gd.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: June 21, 2022
• Study Start: October 1, 2022
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: July 27, 2022

Record last verified: 2022-07