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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04484558
• Other study ID #: 01001297992
• Status: Recruiting
• Start date: January 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: July 2020
• Source: Assiut University
• Contact: Ebtsam Mohamed Tawfik
• Phone: +0201001297992
• Email: ebtsamtawfik393[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2020
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

1. age more than 40.

2. None of the pt had history of other psychiatric illness.

3. male and female.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Acute Stroke
• Anxiety Disorders
• Depression
• Depressive Disorder
• Stroke

Intervention

Drug:
• Actilyse
Infusion

Locations

Country	Name	City	State
Egypt	Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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 — View Citation

Musumeci G, Sciarretta C, Rodríguez-Moreno A, Al Banchaabouchi M, Negrete-Díaz V, Costanzi M, Berno V, Egorov AV, von Bohlen Und Halbach O, Cestari V, Delgado-García 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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection and measureing anxiety and depressive symptoms in ischemic stroke patients treated with rtpA .	Hamilton depression and anxiety rating scale	15 minutes
Secondary	Measuring quality of life in patients with ischemic stroke treated wih rtpA .	Quality of life questionnaire	10 minutes