Major Depressive DisorderPhase 2NCT00166296

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

A Phase 2 study testing Escitalopram in people with Major Depressive Disorder and Hepatitis C, Chronic, run by Germans Trias i Pujol Hospital at 15 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder, Hepatitis C, Chronic
What is being tested?: Escitalopram
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 133 participants
Where: 15 sitesSpain
Study dates: Mar 2005to Oct 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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).

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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-).

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

Spain15 sites

Fundacion Hospital Alcorcon
Alcorcón
Hospital Nuestra Señora de Sonsoles
Ávila
Hospital Universitari Germans Trias i Pujol
Badalona, 08916
Hospital del Mar
Barcelona
Hospital Puerta de Hierro
Madrid
Hospital Ramon y Cajal
Madrid
Hospital Universitario La Paz
Madrid
Hospital Universitario La Princesa
Madrid
Hospital Parc Tauli
Sabadell
Hospital Universitario de Salamanca
Salamanca
Hospital Consorci Sanitari de Terrassa
Tarrasa
Hospital Clínico Universitario
Valencia
Hospital General Universitario
Valencia
Hospital La Fe
Valencia
Hospital Miguel Servet
Zaragoza

Other trials in Spain

About this study

Official title: Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Read the detailed description

Chronic hepatitis C is a prevalent condition, and the main cause of chronic liver diseases, including cirrhosis and cancer. Nowadays, interferon-alfa in combination with ribavirin is the main treatment option for this condition. In the last years, interferon molecule has been modified in order to improve tolerance into pegylated interferon.

Interferon-alfa has been associated with a high prevalence of psychiatric side effects, especially major depression (up to 25% of the cases), which is one of the main concerns about using this treatment. In fact, major depression is one of the main reasons of treatment withdrawal and treatment failure.

Major depression induced by interferon-alfa can be successfully treated with antidepressants, but we don't know if antidepressants can also prevent the development of major depression, and if this can be a safe intervention. In the literature, there is only one controlled trial about this issue, in cancer patients, and some open studies in hepatitis C.

In order to evaluate the efficacy, and safety, of an antidepressant (escitalopram) for preventing peginterferon's induced depressive episodes in patients with chronic hepatitis C, we have designed this 14-weeks placebo-controlled, double-blind, randomized clinical trial. Study interventions will be started two weeks before peginterferon + ribavirin's treatment onset.

Subjects included in the study will be patients with chronic hepatitis C who are going to be treated with peginterferon-alfa2a + ribavirin, and without mental disorders requiring active psychotropic treatment.

The main variables studied will be the appearance of a major depressive episode, following Diagnostic \& Statistical Manual of Mental Disorders (DSM-IV) criteria, and the total score on the Montgomery-Asberg Depression Rating Scale, along three assessment points at 4, 8 and 12 weeks of treatment with interferon. There will also be a follow-up period of up to 6 months after treatment with interferon is completed.

Conditions: Major Depressive Disorder, Hepatitis C, Chronic
Being tested: Escitalopram, Placebo
Keywords: Major depressive disorder, chemically induced., Peginterferon alfa-2a., Escitalopram., Chronic hepatitis C, psychology., Prophylactic treatment.
Medical subject headings: Depressive Disorder, Major, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EscitalopramDrug
Also called Cipralex
15 mg/day starting 2 weeks before and 12 weeks during interferon therapy
PlaceboDrug
Placebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.

Study groups in NCT00166296
Study group	Role	What they receive
Escitalopram	Experimental	Escitalopram, 15 mg/day Receives: Drug: Escitalopram
Placebo pill	Placebo comparator	Placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Six months after the end of interferon treatment

Secondary outcomes (2)

Total Score in the Montgomery-Asberg Depression Rating Scale
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.
Measured: 12 weeks after interferon treatment onset
Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.
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.
Measured: 12 weeks after interferon treatment onset

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2005Oct 2007

First posted14 Sep 2005 (estimated)
Study startMar 2005
Primary completionOct 2007
Study completionOct 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 133 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00166296
Sponsor's protocol ID: PSQHEPGTP1
Other IDs: EudraCT number: 2004-002982-19
Status last verified: Aug 2020
First submitted: 9 Sep 2005
Last updated: 17 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 21034680

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Efficacy and Safety of Escitalopram for the Prevention of Depressive Episodes Induced by Peg-Interferon Alpha2a and Ribavirin in Chronic Hepatitis C Patients. Randomized, Double-Blind, Placebo-Controlled Clinical Trial
ClinicalTrials.gov ID: NCT00166296
Acronym / sponsor ID: PSQHEPGTP1
Conditions: Major Depressive Disorder, Hepatitis C, Chronic
Keywords: Major depressive disorder, chemically induced., Peginterferon alfa-2a., Escitalopram., Chronic hepatitis C, psychology., Prophylactic treatment.
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 133 participants (actual)
Lead sponsor: Germans Trias i Pujol HospitalUniversity, hospital or other
Collaborators: Hoffmann-La Roche, H. Lundbeck A/S
Study start: Mar 2005
Primary completion: Oct 2007 (actual)
Study completion: Oct 2007 (actual)
First posted: 14 Sep 2005 (estimated)
Results: Posted 30 Mar 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Escitalopram	Experimental	Drug: EscitalopramEscitalopram, 15 mg/day
Placebo pill	Placebo comparator	Drug: PlaceboPlacebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (9 listed)

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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
EscitalopramAlso: Cipralex15 mg/day starting 2 weeks before and 12 weeks during interferon therapy	Drug	Escitalopram
PlaceboPlacebo, 15 mg/day, starting 2 weeks before and for 12 weeks during interferon therapy.	Drug	Placebo pill

Primary outcome

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.
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.
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
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.

2 secondary outcomes

Total Score in the Montgomery-Asberg Depression Rating Scale
Time frame: 12 weeks after interferon treatment onset
Total Score in the Depression Subscale of the Hospital Anxiety and Depression Scale.
Time frame: 12 weeks after interferon treatment onset

Results and safety

Results posted to the registry on 30 Mar 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Escitalopram	67	60
Placebo	66	57

Primary outcome: 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.. Number. Unit: Participants

Measure	Escitalopram n = 66	Placebo n = 63
Value	5	2

Escitalopram vs Placebo: Odds Ratio (OR): 0.400 (95% CI 0.075 to 2.141), p = 0.441, Fisher Exact

Population analysed: 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).

Primary outcome: 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. Number. Unit: Participants

Measure	Escitalopram n = 53	Placebo n = 54
Value	36	38

Escitalopram vs Placebo: p >0.05, Chi-squared

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

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: First three months of antiviral treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Escitalopram	0 of 66 (0%)	60 of 66 (90.9%)	Not reported
Placebo	0 of 63 (0%)	58 of 66 (87.9%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21034680Diez-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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Crisanto Diez-Quevedo, MD principal investigator

Germans Trias i Pujol Hospital

Ramon Planas, MD principal investigator

Germans Trias i Pujol Hospital

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Escitalopram in people with Major Depressive Disorder and Hepatitis C, Chronic, run by Germans Trias i Pujol Hospital at 15 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00166296, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.