Antidepressant Prophylaxis for Interferon-Induced Depress... | NCT00357045

Studies
Antidepressant Prophylaxis for Interferon-Induced Depression: Efficacy of Paroxetine

NCT00357045

Sponsor

Portland VA Medical Center

Status

Completed

Last Update Posted

Jul 27, 2006Estimated

Enrollment

Not provided

Phase

Phase 4

Conditions

Major Depression

Interventions

Paroxetine

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2003

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 25, 2006

First Submission Date that Met QC Criteria

Jul 25, 2006

First Posted Date

Jul 27, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2006

Last Update Posted Date

Jul 27, 2006Estimated

Name	Class
GlaxoSmithKline	INDUSTRY
Schering-Plough	INDUSTRY

Description Module

Brief Summary

Objectives:

To determine whether paroxetine can prevent major depression in patients with hepatitis C (HCV) who are receiving pegylated-interferon (Peg-IFN).
To determine whether paroxetine can prevent subsyndromal increases in depression and anxiety in patients with HCV who are receiving Peg-IFN.
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.
To determine whether paroxetine improves compliance with Peg-IFN therapy for HCV.
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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Paroxetine	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003866	Depressive Disorder
D019964	Mood Disorders
D001523	Mental Disorders

ID	Term
D010880	Piperidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds