DepressionPhase 3PICCONCT00317746
Trial of Citalopram for the Prevention of Depression
A Phase 3 study testing Citalopram in people with Depression and HIV Infections, run by Marina Klein at 1 site in Canada.
Trial summary
With the improved prognosis of human immunodeficiency virus (HIV) infection, end stage liver disease due to hepatitis C (HCV) now represents a major cause of morbidity and mortality in people with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, HIV Infections, Hepatitis C
- What is being tested?
- Citalopram
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2006to Mar 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN/ribavirin will be enrolled.
Who cannot join
- Subjects with prior suicide attempt, active depression, treatment with antidepressants within 6 months of study entry or with other psychiatric disorders will be excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Immunodeficiency Service Montreal Chest Institute McGill University Health Centre
Montreal, Quebec, H2X 2P4
About this study
Official title: A Randomized, Placebo Controlled Trial of Citalopram for the Prevention of Depression and Its Consequences in HIV-Hepatitis C Co-infected Individuals Initiating Pegylated Interferon/Ribavirin Therapy
With the improved prognosis of human immunodeficiency virus (HIV) infection, end stage liver disease due to hepatitis C (HCV) now represents a major cause of morbidity and mortality in people with HIV. Treatment for HCV has become increasingly important as a means of preventing the consequences of chronic HCV infection. Paradoxically, co-infected patients have low rates of treatment initiation and completion in large part because they have a high risk of developing neuropsychiatric symptoms while receiving PEG-interferon (PEG-IFN). There are a large number of co-infected individuals in Canada who could benefit from HCV therapy if tolerability could be improved. This trial will address whether prophylactic use of antidepressants in HIV-HCV infected patients initiating HCV therapy can prevent the development of neuropsychiatric side effects and thus permit more patients to receive full treatment for HCV.
Read the detailed description
Trial design:
This study is a Canadian multicentre randomized, double-blind placebo controlled trial. We will evaluate whether prophylactic citalopram compared to symptomatic treatment of depression can significantly increase the amount of HCV therapy received in co-infected patients during the first 24 weeks. Post study follow-up will extend until 6 months after cessation of HCV therapy (up to 72 weeks) to capture information on SVR (sustained virologic response) for HCV. 76 patients will be randomized in a 1:1 ratio to citalopram or placebo. Patients will be stratified by study centre and HCV genotype. Citalopram (or placebo) will begin 3 weeks before HCV treatment at an initial dose of 10 mg per day then be increased to 20 mg per day after one week and continued throughout treatment with PEG-IFN/ribavirin (up to 48 weeks) and then tapered to discontinuation at completion of HCV therapy. The management of depression emerging in study participants is mandated in the protocol to ensure that the original treatment assignments remain blinded while allowing for all subjects to remain in the study and mimics what would take place in clinical practice.
Analysis:
The analyses will follow the intention-to-treat approach. Random regression modelling will be employed to analyse longitudinal data on adherence to prescribed PEG-IFN and ribavirin dosage at weeks 12 and 24. Survival analyses will be used to compare the two treatment groups with respect to the time to the development of depressions.
Implications:
Prophylactic antidepressants may not only prevent overt depression but may also diminish the development of sub-clinical depressed mood. Effective prevention of a broad range of neuropsychiatric symptoms by use of citalopram has the potential to diminish morbidity associated with PEG-IFN treatment and consequently allow a greater number of patients to complete full therapy. In addition, such an approach may help patients remain adherent to their HIV therapy during the course of HCV treatment which could have long-term personal and public health implications by preventing the emergence of HIV resistance. Furthermore, if shown to be an effective strategy for preventing neuropsychiatric symptoms, treatment for HCV may become more accessible to the large number of patients who may not have ready access to the frequent and intensive psychiatric monitoring, necessary for the early detection and treatment of depression that manifests on PEG-IFN.
- Conditions
- Depression, HIV Infections, Hepatitis C
- Being tested
- Citalopram, Placebos
- Keywords
- HIV/HCV Co-infection, Depression, Citalopram
- Medical subject headings
- Depression, HIV Infections, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CitalopramDrug
PlacebosDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo + PEG-interferon-alfa2b + ribavirin Receives: Drug: Placebos |
| Citalopram | Experimental | Citalopram + PEG-interferon-alpha2b + ribavirin Receives: Drug: Citalopram |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the average proportion of PEG-IFN and ribavirin doses received in participants receiving citalopram compared with placebo
Measured: week 24
A second major objective is to compare arms with respect to the rate of moderate-to-severe depressive symptoms during the first 24 weeks of therapy.
Measured: week 12 and week 24
Secondary outcomes (2)
Secondary measures will assess impact of citalopram versus placebo on anxiety, neurocognitive function, quality of life and adherence to therapy. HCV and HIV control will also be examined.
Measured: 24 weeks
Substudies aimed at understanding the pathogenesis of neuropsychiatric side effects and neurocognitive function in this population will be performed.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2006 (estimated)
- Study startNov 2006
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marina Klein
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario HIV Treatment Network, Schering-Plough, CIHR Canadian HIV Trials Network
- Responsible party
- Sponsor-investigator, Marina Klein, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Marina B Klein, MD, Principal investigator, Immunodeficiency Service Montreal Chest Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00317746
- Sponsor's protocol ID
- CTN194
- Other IDs
- Schering #2229
- Acronym
- PICCO
- Status last verified
- May 2017
- First submitted
- 21 Apr 2006
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Klein MB, Lee T, Brouillette MJ, Sheehan NL, Walmsley S, Wong DK, Conway B, Hull M, Cooper C, Haidar S, Vezina S, Annable L, Young S, Zubyk W, Singer J. Citalopram for the prevention of depression and its consequences in HIV-hepatitis C coinfected individuals initiating pegylated interferon/ribavirin therapy: a multicenter randomized double-blind placebo-controlled trial. HIV Clin Trials. 2014 Jul-Aug;15(4):161-75. doi: 10.1310/hct1504-161.
PubMed 25143025
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo Controlled Trial of Citalopram for the Prevention of Depression and Its Consequences in HIV-Hepatitis C Co-infected Individuals Initiating Pegylated Interferon/Ribavirin Therapy
- ClinicalTrials.gov ID
- NCT00317746
- Acronym / sponsor ID
- PICCO / CTN194
- Conditions
- Depression, HIV Infections, Hepatitis C
- Keywords
- HIV/HCV Co-infection, Depression, Citalopram
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Marina KleinUniversity, hospital or other
- Collaborators
- Ontario HIV Treatment Network, Schering-Plough, CIHR Canadian HIV Trials Network
- Study start
- Nov 2006
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 25 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
With the improved prognosis of human immunodeficiency virus (HIV) infection, end stage liver disease due to hepatitis C (HCV) now represents a major cause of morbidity and mortality in people with HIV. Treatment for HCV has become increasingly important as a means of preventing the consequences of chronic HCV infection. Paradoxically, co-infected patients have low rates of treatment initiation and completion in large part because they have a high risk of developing neuropsychiatric symptoms while receiving PEG-interferon (PEG-IFN). There are a large number of co-infected individuals in Canada who could benefit from HCV therapy if tolerability could be improved. This trial will address whether prophylactic use of antidepressants in HIV-HCV infected patients initiating HCV therapy can prevent the development of neuropsychiatric side effects and thus permit more patients to receive full treatment for HCV.
Detailed description
Trial design:
This study is a Canadian multicentre randomized, double-blind placebo controlled trial. We will evaluate whether prophylactic citalopram compared to symptomatic treatment of depression can significantly increase the amount of HCV therapy received in co-infected patients during the first 24 weeks. Post study follow-up will extend until 6 months after cessation of HCV therapy (up to 72 weeks) to capture information on SVR (sustained virologic response) for HCV. 76 patients will be randomized in a 1:1 ratio to citalopram or placebo. Patients will be stratified by study centre and HCV genotype. Citalopram (or placebo) will begin 3 weeks before HCV treatment at an initial dose of 10 mg per day then be increased to 20 mg per day after one week and continued throughout treatment with PEG-IFN/ribavirin (up to 48 weeks) and then tapered to discontinuation at completion of HCV therapy. The management of depression emerging in study participants is mandated in the protocol to ensure that the original treatment assignments remain blinded while allowing for all subjects to remain in the study and mimics what would take place in clinical practice.
Analysis:
The analyses will follow the intention-to-treat approach. Random regression modelling will be employed to analyse longitudinal data on adherence to prescribed PEG-IFN and ribavirin dosage at weeks 12 and 24. Survival analyses will be used to compare the two treatment groups with respect to the time to the development of depressions.
Implications:
Prophylactic antidepressants may not only prevent overt depression but may also diminish the development of sub-clinical depressed mood. Effective prevention of a broad range of neuropsychiatric symptoms by use of citalopram has the potential to diminish morbidity associated with PEG-IFN treatment and consequently allow a greater number of patients to complete full therapy. In addition, such an approach may help patients remain adherent to their HIV therapy during the course of HCV treatment which could have long-term personal and public health implications by preventing the emergence of HIV resistance. Furthermore, if shown to be an effective strategy for preventing neuropsychiatric symptoms, treatment for HCV may become more accessible to the large number of patients who may not have ready access to the frequent and intensive psychiatric monitoring, necessary for the early detection and treatment of depression that manifests on PEG-IFN.
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 |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlacebosPlacebo + PEG-interferon-alfa2b + ribavirin |
| Citalopram | Experimental | Drug: CitalopramCitalopram + PEG-interferon-alpha2b + ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN/ribavirin will be enrolled.
Key exclusion criteria (1 listed)
- Subjects with prior suicide attempt, active depression, treatment with antidepressants within 6 months of study entry or with other psychiatric disorders will be excluded.
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 |
|---|---|---|
| Citalopram | Drug | Citalopram |
| Placebos | Drug | Placebo |
Primary outcome
The primary outcome is the average proportion of PEG-IFN and ribavirin doses received in participants receiving citalopram compared with placebo
Time frame: week 24
A second major objective is to compare arms with respect to the rate of moderate-to-severe depressive symptoms during the first 24 weeks of therapy.
Time frame: week 12 and week 24
2 secondary outcomes
Secondary measures will assess impact of citalopram versus placebo on anxiety, neurocognitive function, quality of life and adherence to therapy. HCV and HIV control will also be examined.
Time frame: 24 weeks
Substudies aimed at understanding the pathogenesis of neuropsychiatric side effects and neurocognitive function in this population will be performed.
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2017.
- Derived from this study: PubMed 25143025Klein MB, Lee T, Brouillette MJ, Sheehan NL, Walmsley S, Wong DK, Conway B, Hull M, Cooper C, Haidar S, Vezina S, Annable L, Young S, Zubyk W, Singer J. Citalopram for the prevention of depression and its consequences in HIV-hepatitis C coinfected individuals initiating pegylated interferon/ribavirin therapy: a multicenter randomized double-blind placebo-controlled trial. HIV Clin Trials. 2014 Jul-Aug;15(4):161-75. doi: 10.1310/hct1504-161.
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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.
Marina B Klein, MD principal investigator
Immunodeficiency Service Montreal Chest Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Citalopram in people with Depression and HIV Infections, run by Marina Klein at 1 site in Canada.
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 1 inclusion and 1 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome is the average proportion of PEG-IFN and ribavirin doses received in participants receiving citalopram compared with placebo (time frame: week 24). 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 NCT00317746, 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 22 May 2017.