Frequency of Anxiety and Depression in Chronic Hepatitis C Patients Recieving Direct-Acting Antiviral Agents

NCT03894696 | Unknown

• 1 other identifier: DAAs and psychiatry
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective of this study is to prospectively analyse psychiatric outcomes, specifically depression and anxiety in patients with hepatitis C virus infection who are initiated on DAA therapy (sofosbuvir based regimen).

Conditions

Chronic Hepatitis c

Outcome Measures

Primary Outcomes (1)

• frequency of anxiety and depression in chronic HCV patients recieving DAAs.

  to detect occurance of psychatric disorders specifically anxiety and depression in chronic HCV patients treated with DAAs ( sofosbuvir based regimens).

  6 months .

Interventions

Direct Acting Antivirals DRUG

follow up chronic HCV patients recieving DAAs to detect anxiety and depression

Eligibility Criteria

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

Study Population

Patients fulfilling the inclusion criteria will attend the hepatitis outpatient clinic of Al-Rajhi Liver Hospital. Selected patients will be followed up for 6 months.

You may qualify if:

• years and older Chronic Hepatitis C infection Naive patients who will start a 12-week DAA therapy Acceptance to share in study

You may not qualify if:

• Recieving antipsychotic . Previous failure of DAA agents. Significant life-threatening diseases HCV related liver cirrhosis. Non HCV related liver disease

Sponsors & Collaborators

• Assiut University: lead

Related Publications (17)

• Sockalingam S, Sheehan K, Feld JJ, Shah H. Psychiatric care during hepatitis C treatment: the changing role of psychiatrists in the era of direct-acting antivirals. Am J Psychiatry. 2015 Jun;172(6):512-6. doi: 10.1176/appi.ajp.2015.14081041. No abstract available.

  PMID: 26029803 BACKGROUND

• Tang LS, Masur J, Sims Z, Nelson A, Osinusi A, Kohli A, Kattakuzhy S, Polis M, Kottilil S. Safe and effective sofosbuvir-based therapy in patients with mental health disease on hepatitis C virus treatment. World J Hepatol. 2016 Nov 8;8(31):1318-1326. doi: 10.4254/wjh.v8.i31.1318.

  PMID: 27872683 BACKGROUND

• Rowan PJ, Bhulani N. Psychosocial assessment and monitoring in the new era of non-interferon-alpha hepatitis C virus treatments. World J Hepatol. 2015 Sep 8;7(19):2209-13. doi: 10.4254/wjh.v7.i19.2209.

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• Younossi ZM, Stepanova M, Henry L, Nader F, Younossi Y, Hunt S. Adherence to treatment of chronic hepatitis C: from interferon containing regimens to interferon and ribavirin free regimens. Medicine (Baltimore). 2016 Jul;95(28):e4151. doi: 10.1097/MD.0000000000004151.

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• Banerjee D, Reddy KR. Review article: safety and tolerability of direct-acting anti-viral agents in the new era of hepatitis C therapy. Aliment Pharmacol Ther. 2016 Mar;43(6):674-96. doi: 10.1111/apt.13514. Epub 2016 Jan 20.

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  BACKGROUND

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MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dina khaled

CONTACT

00201096006362; dr.dina567@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident at gastroenterology and tropical medicine -Assiut university

Study Record Dates

• First Submitted: March 26, 2019
• First Posted: March 28, 2019
• Study Start: August 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: May 1, 2020
• Last Updated: July 8, 2019

Record last verified: 2019-07