Clinical trial NCT00357045: Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine
Official title: Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine; THE HEPDEP II STUDY
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depression
Lead sponsor: Portland VA Medical Center
Sponsor class: FED
Collaborators: name: GlaxoSmithKline
name: Schering-Plough
First posted: 2006-07-27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Objectives:

1. To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN).
2. To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN.
3. To determine whether paroxetine can prevent a significant change in the health related quality of life in patients with HCV who are receiving Peg-IFN.
4. To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.
5. To determine whether paroxetine enables patients to complete Peg-IFN therapy for HCV who might otherwise require a dose reduction or discontinuation because of neuropsychiatric side effects.


Eligibility criteria: Inclusion Criteria:

* 18 or older
* diagnosis of hepatitis C
* agree to participate in the study with written informed consent
* plan to undergo treatment with Peg-IFN + Ribavirin
* compensated liver disease (hemoglobin value \> 12 gm/dL for females or \> 13 gm/dL for males, WBC \> 3000/mm3, platelets \> 70,000/mm3, albumin \> 3.0 g/dL or within 20% of LLN, Serum creatinine \< 1.4 mg/dL, thyroid stimulating hormone within normal limits
* confirmation from female patients that adequate contraception is being practiced during treatment period and for 6 months after discontinuation of therapy
* confirmation from male patients that acceptable contraception is being practiced

Exclusion Criteria:

* hypersensitivity to IFN, RBV, or paroxetine
* chronic liver disease other than chronic HCV
* hemolytic anemia from any cause including hemoglobinopathies
* evidence of advance liver disease
* any preexisting medical condition that could interfere with participation in the protocol
* evidence of cardiac ischemia, a significant unstable cardiac arrhythmia, heart failure, recent coronary artery surgery, uncontrolled HTN, unstable angina, or MI within past 12 months
* clinically significant retinal abnormalities
* substance abuse (must have abstained from abusing substance for at least 6 months)
* diagnosis of major depression in the past 6 weeks
* currently receiving full therapeutic dose of antidepressant medications
* diagnosis of bipolar disorder
* active psychotic condition
* active delirium
* pregnant female patients, men whose sexual partner is currently pregnant, and men and women who are not practicing adequate contraception
* female patients who are actively breast feeding
* patients with a known history of non-compliance with medical treatment

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Salem VA Medical Center
name: J. K. Moles, M.D.
role: PRINCIPAL_INVESTIGATOR
References: