Trial of Citalopram for the Prevention of Depression

NCT00317746 | Completed Phase 3 DMC

• 2 other identifiers: CTN194Schering #2229
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Depression; HIV Infections; Hepatitis C

Keywords

HIV/HCV Co-infection; Depression; Citalopram

Outcome Measures

Primary Outcomes (2)

• The primary outcome is the average proportion of PEG-IFN and ribavirin doses received in participants receiving citalopram compared with placebo

  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.

  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.

  24 weeks

• Substudies aimed at understanding the pathogenesis of neuropsychiatric side effects and neurocognitive function in this population will be performed.

  24 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo + PEG-interferon-alfa2b + ribavirin

Drug: Placebos

Citalopram

EXPERIMENTAL

Citalopram + PEG-interferon-alpha2b + ribavirin

Drug: Citalopram

Interventions

Citalopram DRUG

Citalopram

Placebos DRUG

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HIV+ adults with chronic HCV infection requiring therapy and with no contraindications to PEG-IFN/ribavirin will be enrolled.

You may not qualify if:

• Subjects with prior suicide attempt, active depression, treatment with antidepressants within 6 months of study entry or with other psychiatric disorders will be excluded.

Sponsors & Collaborators

• Marina Klein: lead
• Ontario HIV Treatment Network: collaborator
• Schering-Plough: collaborator
• CIHR Canadian HIV Trials Network: collaborator

Study Sites (1)

Immunodeficiency Service Montreal Chest Institute McGill University Health Centre

Montreal, Quebec, H2X 2P4, Canada

Location

Related Publications (1)

• 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.

  PMID: 25143025 DERIVED

MeSH Terms

Conditions

Depression; HIV Infections; Hepatitis C

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Marina B Klein, MD

  Immunodeficiency Service Montreal Chest Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Study Principal Investigator

Study Record Dates

• First Submitted: April 21, 2006
• First Posted: April 25, 2006
• Study Start: November 1, 2006
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

CA (1)