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

This study has been completed.

Study NCT00166296 Information provided by Germans Trias i Pujol Hospital

First Received on September 9, 2005. Last Updated on March 4, 2011 History of Changes

Results First Received: February 8, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Major Depressive Disorder. Hepatitis C, Chronic
Interventions:	Drug: Escitalopram Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited among chronic hepatitis C patients between 18 and 65 years old, referred by general practitioners between March 2005 and July 2006 to gastroenterology outpatient units in 15 academic general hospitals in Spain, who were suitable to initiate treatment with pegylated interferonalfa-2a and ribavirin.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Escitalopram	Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Placebo	Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment

Participant Flow: Overall Study

	Escitalopram	Placebo
STARTED	67 ^[1]	66 ^[1]
ANALYZED	66 ^[2]	63 ^[2]
COMPLETED	60 ^[3]	57 ^[3]
NOT COMPLETED	7	9
Withdrawal by Subject	1	3
Adverse Event	2	4
Lost to Follow-up	4	2

[1]	Randomized patients
[2]	Patients who did receive at least the first dose of study medications, included in the analysis
[3]	Patients who completed both trial medication and interferon+ribavirin treatment for 12 weeks

Baseline Characteristics

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Reporting Groups

	Description
Escitalopram	Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Placebo	Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment

Baseline Measures

	Escitalopram	Placebo	Total
Number of Participants [units: participants]	67	66	133
Age [units: participants]
Between 18 and 65 years	67	66	133
Age [units: years] Mean ± Standard Deviation	46.7 ± 10.6	44.8 ± 10.8	45.8 ± 10.7
Gender [units: participants]
Female	28	25	53
Male	39	41	80
Region of Enrollment [units: participants]
Spain	67	66	133

Outcome Measures

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1. Primary:

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. [ Time Frame: First three months of interferon treatment. ]

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2. Primary:

Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid). [ Time Frame: Six months after the end of interferon treatment ]

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3. Secondary:

Total Score in the Montgomery-Asberg Depression Rating Scale [ Time Frame: 12 weeks after interferon treatment onset ]

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4. Secondary:

Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale. [ Time Frame: 12 weeks after interferon treatment onset ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Crisanto Diez-Quevedo
Organization: Hospital Universitari Germans Trias i Pujol, Autonomous University of Barcelona
phone: +34934978814
e-mail: cdiezquevedo.germanstrias@gencat.cat

Publications of Results:

Diez-Quevedo C, Masnou H, Planas R, Castellví P, Giménez D, Morillas RM, Martín-Santos R, Navinés R, Solá R, Giner P, Ardévol 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. 2010 Oct 5; [Epub ahead of print]

Responsible Party:	Crisanto Diez-Quevedo, Germans Trias i Pujol Hospital
ClinicalTrials.gov Identifier:	NCT00166296 History of Changes
Other Study ID Numbers:	PSQHEPGTP1, EudraCT number: 2004-002982-19
Study First Received:	September 9, 2005
Results First Received:	February 8, 2011
Last Updated:	March 4, 2011
Health Authority:	Spain: Spanish Agency of Medicines