Trial of Citalopram for the Prevention of Depression (PICCO)
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ClinicalTrials.gov Identifier: NCT00317746 |
Recruitment Status
:
Completed
First Posted
: April 25, 2006
Last Update Posted
: May 22, 2017
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression HIV Infections Hepatitis C | Drug: Citalopram Drug: Placebos | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 76 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Study Start Date : | November 2006 |
Actual Primary Completion Date : | March 2012 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: Placebo
Placebo + PEG-interferon-alfa2b + ribavirin
|
Drug: Placebos |
Experimental: Citalopram
Citalopram + PEG-interferon-alpha2b + ribavirin
|
Drug: Citalopram |
- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN/ribavirin will be enrolled.
Exclusion Criteria:
- Subjects with prior suicide attempt, active depression, treatment with antidepressants within 6 months of study entry or with other psychiatric disorders will be excluded.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00317746
Canada, Quebec | |
Immunodeficiency Service Montreal Chest Institute McGill University Health Centre | |
Montreal, Quebec, Canada, H2X 2P4 |
Principal Investigator: | Marina B Klein, MD | Immunodeficiency Service Montreal Chest Institute |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Marina Klein, Study Principal Investigator, McGill University Health Center |
ClinicalTrials.gov Identifier: | NCT00317746 History of Changes |
Other Study ID Numbers: |
CTN194 Schering #2229 |
First Posted: | April 25, 2006 Key Record Dates |
Last Update Posted: | May 22, 2017 |
Last Verified: | May 2017 |
Keywords provided by Marina Klein, McGill University Health Center:
HIV/HCV Co-infection Depression Citalopram |
Additional relevant MeSH terms:
Depression Depressive Disorder Hepatitis Hepatitis C HIV Infections Behavioral Symptoms Mood Disorders Mental Disorders Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections Lentivirus Infections |
Retroviridae Infections Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Interferons Ribavirin Peginterferon alfa-2b Citalopram Dexetimide Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action |