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DepressionPhase 4PRAISEDNCT05426304

Prophylactic Effects of Agomelatine for Poststroke Depression

A Phase 4 study testing Agomelatine in people with Depression and Acute Ischemic Stroke, run by First Affiliated Hospital, Sun Yat-Sen University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Depression, Acute Ischemic Stroke
What is being tested?
Agomelatine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
420 participants
Where
No sites listed yet
Study dates
1 Oct 2022to 31 May 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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
  • unsuitable for inclusion considered by the investigators

Trial locations and contacts

No sites are listed yet.

Jinsheng Zeng contact

13322800657

zengjs@pub.guangzhou.gd.cn

About this study

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Agomelatine in the Prevention of Poststroke Depression

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.

Read the detailed 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.

Being tested
Agomelatine, Placebo Tablets
Keywords
poststroke depression, prevention, agomelatine
Medical subject headings
Depression, Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AgomelatineDrug

    Also called Agomelatine Tablets

    agomelatine 25 mg/day for 180 days

  • Placebo TabletsDrug

    Also called Placebo Placebo

    placebo 25 mg/day for 180 days

Study groups in NCT05426304
Study groupRoleWhat they receive
AgomelatineExperimentalThe Agomelatine group will be received agomelatine (25 mg/day) for 180 days.
Receives: Drug: Agomelatine
PlaceboPlacebo comparatorThe Placebo group will be received placebo (25 mg/day) for 180 days.
Receives: Drug: Placebo Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 180 days

Secondary outcomes (14)

  1. rate of recurrence of ischemic stroke within 90 days

    1. Acute onset of focal neurological deficit, a few can be comprehensive neurological deficit. 2. Brain CT/MRI confirms the corresponding infarct focus in the brain, or the symptoms and signs continue for more than 24h, or cause death within 24h. 3. Exclude non-ischemic causes.
    2. brain ct/mri confirmed the corresponding infarct focus in the brain, or the symptoms and signs continued for more than 24h, or caused death within 24h.
    3. exclude non ischemic causes.

    Measured: 90±7 days

  2. variation of HAMD-17 score from baseline

    range from 0 to 50; the higher, the worse

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

  3. rate of sleep disorder

    range from 0 to 21; > 7, having sleep disorder

    Measured: 180 days

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

    range from 0 to 21; the higher, the worse; > 7, having sleep disorder

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

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

    range from 50 to 248; the higher, the better

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

  6. variation of Modified Rankin Scale (mRS) score from baseline

    range from 0 to 5; the higher, the worse

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

  7. variation of National Institutes of Health Stroke Scale (NIHSS) from baseline

    range from 0 to 42; the higher, the worse

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

  8. variation of Montreal Cognitive Assessment (MOCA) from baseline

    range from 0 to 30; the lower, the worse

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

  9. variation of Mini Mental State Examination (MMSE) score from baseline

    range from 0 to 30; the lower, the worse

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

  10. variation of Epworth Sleepiness Scale (ESS) from baseline

    range from 9 to 63; the higher, the worse

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

  11. rate of all-caused mortality

    death due to all causes

    Measured: 180 days

  12. variation of Fatigue Severity Scale (FSS) from baseline

    range from 0 to 24; >=24, having drowsiness tendency

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

  13. rate of vascular events

    defined as the composite of stroke, transient ischemic attack (TIA), myocardial infarction and vascular death

    Measured: 180 days

  14. rate of liver injury

    defend as the level of ALT 2 times higher than the upper limit of normal range

    Measured: 28±3 days, 90±7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jun 2022
  2. Study start1 Oct 2022 (estimated)
  3. Primary completion31 May 2024 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
420 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05426304
Sponsor's protocol ID
PRAISED
Acronym
PRAISED
Status last verified
Jul 2022
First submitted
2 May 2022
Last updated
27 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 29412338

  • 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.

    PubMed 25117911

  • 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.

    PubMed 26684921

  • 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.

    PubMed 29128343

  • 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.

    PubMed 24744682

  • 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.

    PubMed 31740211

  • 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.

    PubMed 28012485

  • 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.

    PubMed 30528472

  • Williams LS, Kroenke K, Bakas T, Plue LD, Brizendine E, Tu W, Hendrie H. Care management of poststroke depression: a randomized, controlled trial. Stroke. 2007 Mar;38(3):998-1003. doi: 10.1161/01.STR.0000257319.14023.61. Epub 2007 Feb 15.

    PubMed 17303771

  • 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.

    PubMed 18505948

  • 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.

    PubMed 16889454

  • 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.

    PubMed 21216670

  • 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.

    PubMed 21811172

  • 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.

    PubMed 15641866

  • 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.

    PubMed 12511765

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Agomelatine in people with Depression and Acute Ischemic Stroke, run by First Affiliated Hospital, Sun Yat-Sen University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jinsheng Zeng (13322800657, zengjs@pub.guangzhou.gd.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

rate of PSD within 180 days (time frame: 180 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05426304, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.

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