Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients

NCT00166296 | Completed Phase 2 Results

• 2 other identifiers: PSQHEPGTP1EudraCT number: 2004-002982-19
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 15

Brief Summary

The purpose of this study is to determine whether the use of an antidepressant (escitalopram) can prevent depressive episodes that appear during the treatment with peg-interferon and ribavirin in patients with chronic hepatitis C.

Conditions

Major Depressive Disorder; Hepatitis C, Chronic

Keywords

Major depressive disorder, chemically induced.; Peginterferon alfa-2a.; Escitalopram.; Chronic hepatitis C, psychology.; Prophylactic treatment.

Outcome Measures

Primary Outcomes (2)

• Number of Participants Who Developed a Major Depressive Episode According to Diagnostic & Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) Criteria During the First 12 Weeks of Antiviral Treatment.

  At least five of the symptoms have been present during the same 1-week period: depressed mood, loss of interest or pleasure, weight or appetite changes, insomnia, agitation or retardation, fatigue, feelings of worthlessness or guilt, diminished ability to think or concentrate, recurrent thoughts of death. At least one of the symptoms is either depressed mood or loss of interest. Diagnoses were made by a trained psychiatrist who applied the mood disorders module from the Structured Clinical Interview for DSM-IV Axis I Disorders, non-patient edition (SCID-I/NP) at each study evaluation.

  First three months of interferon treatment.

• Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).

  Number of participants with negativization of serum hepatitis C Virus Ribonucleic Acid (HCV RNA) 6 months after concluding antiviral therapy (sustained viral response). Negativization was defined as the absence of detectable levels of serum HCV RNA using a polymerase chain reaction.

  Six months after the end of interferon treatment

Secondary Outcomes (2)

• Total Score in the Montgomery-Asberg Depression Rating Scale

  12 weeks after interferon treatment onset

• Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.

  12 weeks after interferon treatment onset

Study Arms (2)

Escitalopram

EXPERIMENTAL

Escitalopram, 15 mg/day

Drug: Escitalopram

Placebo pill

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Escitalopram DRUG

15 mg/day starting 2 weeks before and 12 weeks during interferon therapy

Also known as: Cipralex

Escitalopram

Placebo DRUG

Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.

Placebo pill

Eligibility Criteria

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

You may qualify if:

• Patients with chronic hepatitis C who are going to initiate treatment with peginterferon alfa2a + ribavirin.
• Age 18-65 years.
• Signed informed consent.
• If female, they are not in fertile period or they use barrier contraceptives.
• Patients able to understand and fill written questionnaires.

You may not qualify if:

• Hepatic cirrhosis or carcinoma.
• Less than 4000/mm3 leucocytes, or less than 70000/mm3 platelets.
• Hemoglobin less than 11 g/dL (females) or 12 (males).
• Any risk factor for hemolysis.
• Comorbid severe medical conditions (kidney, immune system, lung, heart, thyroid, etc).
• Baseline mental disorders that require antidepressants (depressive disorders and anxiety disorders).
• Other baseline mental disorders (delirium, substance use disorders).
• Mental disorders at any time (dementia, psychotic disorders, bipolar disorders.
• Contraindications of escitalopram (hypersensibility, diabetes, patients using serotoninergic agents, drugs that enhance the risk of bleeding, or monoamineoxidase inhibitors -MAOIs-).

Sponsors & Collaborators

• Germans Trias i Pujol Hospital: lead
• Hoffmann-La Roche: collaborator
• H. Lundbeck A/S: collaborator

Study Sites (15)

Fundacion Hospital Alcorcon

Alcorcón, Spain

Location

Hospital Nuestra Señora de Sonsoles

Ávila, Spain

Location

Hospital Universitari Germans Trias i Pujol

Badalona, 08916, Spain

Location

Hospital del Mar

Barcelona, Spain

Location

Hospital Puerta de Hierro

Madrid, Spain

Location

Hospital Ramon y Cajal

Madrid, Spain

Location

Hospital Universitario La Paz

Madrid, Spain

Location

Hospital Universitario La Princesa

Madrid, Spain

Location

Hospital Parc Tauli

Sabadell, Spain

Location

Hospital Universitario de Salamanca

Salamanca, Spain

Location

Hospital Consorci Sanitari de Terrassa

Tarrasa, Spain

Location

Hospital Clínico Universitario

Valencia, Spain

Location

Hospital General Universitario

Valencia, Spain

Location

Hospital La Fe

Valencia, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

Related Publications (1)

• Diez-Quevedo C, Masnou H, Planas R, Castellvi P, Gimenez D, Morillas RM, Martin-Santos R, Navines R, Sola R, Giner P, Ardevol M, Costa J, Diago M, Pretel J. Prophylactic treatment with escitalopram of pegylated interferon alfa-2a-induced depression in hepatitis C: a 12-week, randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2011 Apr;72(4):522-8. doi: 10.4088/JCP.09m05282blu. Epub 2010 Oct 5.

  PMID: 21034680 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major; Hepatitis C, Chronic

Interventions

Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; 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

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

The low depression rate found may have underpowered the study. Selection of a much less depressive sample than in other studies. Limitation to the first 12 weeks of antiviral treatment.

Results Point of Contact

• Title: Crisanto Diez-Quevedo
• Organization: Hospital Universitari Germans Trias i Pujol, Autonomous University of Barcelona

cdiezquevedo.germanstrias@gencat.cat

+34934978814

Study Officials

• Crisanto Diez-Quevedo, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

• Ramon Planas, MD

  Germans Trias i Pujol Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 14, 2005
• Study Start: March 1, 2005
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: August 17, 2020
• Results First Posted: March 30, 2011

Record last verified: 2020-08

Locations

ES (15)