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Status unknownNCT04484558Updated Jul 23, 2020

Anxiety and Depression Disorder in Patient Treated With rTPA for Mangment of Acute Ischemic Stroke

An observational study in Acute Stroke, Anxiety Disorders and Depression, sponsored by Assiut University. Status unknown at 1 site in Egypt. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-07-23.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
40
Ages
40 Years to 75 Years
Sex
All
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Study summary

In fact theWorld Health Organization estimates that 2-3% in general populations of countries across the world tend to be affected by severe mental disorders (1) Thrombolytic therapy seems to be of great importance in achieving better quality of life in ischemic stroke patients who respond to this therapy(rTPA).

Read the detailed description

There is a substantial body of evidenc suggesting a strong relation between neurotrophic factors and depression and anxiety pathogenesis (2,8) Brain-derived neurotrophic factor (BDNF), a member of the neurotrophic family known to regulate neuronal plasticity and survival , may play an important role in the pathophysiology of depression and anxiety (3,9).

Different studies indicated patients who were exposed to traumatic events have anxiety comorbidity and lower levels of serum BDNF compared to those without a history of traumatic events (4) .

BDNF has an antidepressant and anxiolytic effect which suggest that BDNF is implicated in the regulation of anxiety-related behaviors. which leads to a valine-to-methionine change in the proBDNF protein, was associated with lower activity-dependent secretion of BDNF (5)and has been implicated with increased susceptibility to neuropsychiatric disorders including depression, anxiety-related dysfunction, and bipolar disorder , all these studies suggest that BDNF is likely to be an important etiological factor in memory, depression and anxiety disorders (6,10).

BDNF arises from a precursor, proBDNF, which is cleaved to produce the mature protein through the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can regulate the action of BDNFarises from a precursor, proBDNF, which is cleaved to produce the mature protein through the tissue plasminogen activator (tPA) pathway, and represents one mechanism that can regulate the action of BDNF (7).

The purpose of this study is to examine the quality of life after stroke of patients treated with thrombolysis .

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Conditions studied

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In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's planned enrollment of 40 is below the median of 160 across 1,692 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Data will be collected from the clinical interpretation of the patients at presentation and from the recent patients' medical records which have the full medical histories and examinations. All patients will be subjected to full neurological history and examination. The results of the above mentioned laboratory, investigations will be included in future analysis and interpretation of patients' abnormal neurological findings.

Inclusion criteria

  1. age more than 40.
  2. None of the pt had history of other psychiatric illness.
  3. male and female.

Exclusion criteria

Exclusion Criteria:

  • 1-smoker. 2-substance abuser or dependence. 3-History of other psychiatric illness. 4-History of other neurological illness.
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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • DrugActilyse

    Infusion

    Also known as: rTpA

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What researchers measure

Primary outcomes

  1. Detection and measureing anxiety and depressive symptoms in ischemic stroke patients treated with rtpA .

    Hamilton depression and anxiety rating scale

    Time frame: 15 minutes

Secondary outcomes

  1. Measuring quality of life in patients with ischemic stroke treated wih rtpA .

    Quality of life questionnaire

    Time frame: 10 minutes

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • Musumeci G, Sciarretta C, Rodriguez-Moreno A, Al Banchaabouchi M, Negrete-Diaz V, Costanzi M, Berno V, Egorov AV, von Bohlen Und Halbach O, Cestari V, Delgado-Garcia JM, Minichiello L. TrkB modulates fear learning and amygdalar synaptic plasticity by specific docking sites. J Neurosci. 2009 Aug 12;29(32):10131-43. doi: 10.1523/JNEUROSCI.1707-09.2009. PubMed 19675247 ↗
  • Noble EE, Billington CJ, Kotz CM, Wang C. The lighter side of BDNF. Am J Physiol Regul Integr Comp Physiol. 2011 May;300(5):R1053-69. doi: 10.1152/ajpregu.00776.2010. Epub 2011 Feb 23. PubMed 21346243 ↗
  • Kauer-Sant'Anna M, Tramontina J, Andreazza AC, Cereser K, da Costa S, Santin A, Yatham LN, Kapczinski F. Traumatic life events in bipolar disorder: impact on BDNF levels and psychopathology. Bipolar Disord. 2007 Jun;9 Suppl 1:128-35. doi: 10.1111/j.1399-5618.2007.00478.x. PubMed 17543031 ↗
  • Li Y, Luikart BW, Birnbaum S, Chen J, Kwon CH, Kernie SG, Bassel-Duby R, Parada LF. TrkB regulates hippocampal neurogenesis and governs sensitivity to antidepressive treatment. Neuron. 2008 Aug 14;59(3):399-412. doi: 10.1016/j.neuron.2008.06.023. Erratum In: Neuron. 2008 Nov 26;60(4):730. PubMed 18701066 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04484558
Lead sponsor
Assiut University
Responsible party
Ebtsam Tawfik (Principal investigator, Assiut University) — Principal investigator
First posted
Jul 23, 2020
Start date
Jan 1, 2020
Primary completion
Dec 1, 2020 (estimated)
Completion
Dec 1, 2021 (estimated)
Last update
Jul 23, 2020

Study contacts

Ebtsam Mohamed Tawfik
Contact
ebtsamtawfik393@gmail.com
+0201001297992

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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