Trial Outcomes & Findings for Efficacy and Safety of Escitalopram for Prevention of Depression Induced by Peg-Interferon in Hepatitis C Patients (NCT NCT00166296)

Last Updated: 2020-08-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

133 participants

Primary outcome timeframe

First three months of interferon treatment.

Results posted on

2020-08-17

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	67	66
Overall Study ANALYZED	66	63
Overall Study COMPLETED	60	57
Overall Study NOT COMPLETED	7	9

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1	3
Overall Study Adverse Event	2	4
Overall Study Lost to Follow-up	4	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=67 Participants Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Placebo n=66 Participants Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Total n=133 Participants Total of all reporting groups
Age, Customized Between 18 and 65 years	67 participants n=5 Participants	66 participants n=7 Participants	133 participants n=5 Participants
Age, Continuous	46.7 years STANDARD_DEVIATION 10.6 • n=5 Participants	44.8 years STANDARD_DEVIATION 10.8 • n=7 Participants	45.8 years STANDARD_DEVIATION 10.7 • n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	25 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	39 Participants n=5 Participants	41 Participants n=7 Participants	80 Participants n=5 Participants
Region of Enrollment Spain	67 participants n=5 Participants	66 participants n=7 Participants	133 participants n=5 Participants

PRIMARY outcome

Timeframe: First three months of interferon treatment.

Population: One of 67 patients allocated to the escitalopram group and 3 of 66 in placebo did not receive the first dose of study medications. Consequently, 66 patients treated with escitalopram and 63 with placebo were included in the intention to treat analysis, with a procedure of last observation carried forward (LOCF).

Outcome measures

Outcome measures
Measure	Escitalopram n=66 Participants Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Placebo n=63 Participants Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
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.	5 Participants	2 Participants

PRIMARY outcome

Timeframe: Six months after the end of interferon treatment

Population: Patients with available data for viral response 6 months after completion of interferon treatment were compared between treatment groups.

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.

Outcome measures

Outcome measures
Measure	Escitalopram n=53 Participants Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Placebo n=54 Participants Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Number of Participants With Sustained Hepatitis C Viral Response (Negativization of Serum Hepatitis C Virus Ribonucleic Acid).	36 Participants	38 Participants

SECONDARY outcome

Timeframe: 12 weeks after interferon treatment onset

The MADRS is a 10-item scale, clinician-administered, which is sensitive to symptom change during antidepressant treatment. It has been frequently used to measure depressive symptoms during interferon-alpha therapy and exhibits improved internal consistency in patients with co-morbid medical conditions compared with other clinician-administered questionnaires. Items are rated on a scale of 0-6. Scores range from 0 to 60, higher scores meaning higher levels of depression.

Outcome measures

Outcome measures
Measure	Escitalopram n=66 Participants Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Placebo n=63 Participants Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Total Score in the Montgomery-Asberg Depression Rating Scale	3.82 Scores on a scale Standard Error 0.57	4.38 Scores on a scale Standard Error 0.63

SECONDARY outcome

Timeframe: 12 weeks after interferon treatment onset

The Hospital Anxiety and Depression Scale (HADS) is 14-item scale, patient-administered, that allows two independent scores of depression and anxiety. It has been specially designed to apply in patients with comorbid medical conditions as it excludes somatic or vegetative symptoms from the depression subscale. We present data of de depression subscale. The seven-item Depression subscale yields a score of 0-21, with higher scores meaning higher levels of depressive symptoms.

Outcome measures

Outcome measures
Measure	Escitalopram n=66 Participants Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Placebo n=63 Participants Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.	2.25 Scores on a Scale Standard Error 0.34	2.13 Scores on a Scale Standard Error 0.33

Adverse Events

Escitalopram

Serious events: 0 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Crisanto Diez-Quevedo

Hospital Universitari Germans Trias i Pujol, Autonomous University of Barcelona

Phone: +34934978814

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Escitalopram n=66 participants at risk Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment	Placebo n=66 participants at risk；n=63 participants at risk Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
Blood and lymphatic system disorders Anemia	7.6% 5/66 • First three months of antiviral treatment	12.7% 8/63 • First three months of antiviral treatment
Psychiatric disorders Anxiety	15.2% 10/66 • First three months of antiviral treatment	17.5% 11/63 • First three months of antiviral treatment
Respiratory, thoracic and mediastinal disorders Breathing problems	24.2% 16/66 • First three months of antiviral treatment	39.7% 25/63 • First three months of antiviral treatment
Gastrointestinal disorders Diarrhea	19.7% 13/66 • First three months of antiviral treatment	15.9% 10/63 • First three months of antiviral treatment
General disorders Dizziness	13.6% 9/66 • First three months of antiviral treatment	4.8% 3/63 • First three months of antiviral treatment
Gastrointestinal disorders Dry mouth	21.2% 14/66 • First three months of antiviral treatment	27.0% 17/63 • First three months of antiviral treatment
General disorders Fatigue	48.5% 32/66 • First three months of antiviral treatment	50.8% 32/63 • First three months of antiviral treatment
General disorders Fever	10.6% 7/66 • First three months of antiviral treatment	9.5% 6/63 • First three months of antiviral treatment
General disorders Flu-like symptoms	13.6% 9/66 • First three months of antiviral treatment	19.0% 12/63 • First three months of antiviral treatment
Skin and subcutaneous tissue disorders Hair loss	13.6% 9/66 • First three months of antiviral treatment	9.5% 6/63 • First three months of antiviral treatment
Nervous system disorders Headache	27.3% 18/66 • First three months of antiviral treatment	30.2% 19/63 • First three months of antiviral treatment
Psychiatric disorders Irritability	15.2% 10/66 • First three months of antiviral treatment	22.2% 14/63 • First three months of antiviral treatment
Blood and lymphatic system disorders Leukopenia / neutropenia	10.6% 7/66 • First three months of antiviral treatment	6.3% 4/63 • First three months of antiviral treatment
Gastrointestinal disorders Loss of appetite	21.2% 14/66 • First three months of antiviral treatment	15.9% 10/63 • First three months of antiviral treatment
Musculoskeletal and connective tissue disorders Muscle or joint pain	33.3% 22/66 • First three months of antiviral treatment	50.8% 32/63 • First three months of antiviral treatment
Gastrointestinal disorders Nausea or vomiting	34.8% 23/66 • First three months of antiviral treatment	33.3% 21/63 • First three months of antiviral treatment
Reproductive system and breast disorders Sexual dysfunction	13.6% 9/66 • First three months of antiviral treatment	4.8% 3/63 • First three months of antiviral treatment
Psychiatric disorders Sleep disorders	34.8% 23/66 • First three months of antiviral treatment	36.5% 23/63 • First three months of antiviral treatment