Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)

DRUG USE INVESTIGATION OF EFFEXOR(REGISTERED) SR CAPSULES

SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE

Study Overview

• Status: Completed
• Conditions: Depression/Depressed State
• Intervention / Treatment: Drug: venlafaxine

Detailed Description

This study will be conducted under the central registration system until the number of subjects who meet the conditions for registration reaches the target number of subjects. 12 weeks from the start date. The patients who completed the 12-week treatment with this product will be observed up until Week 52.

• Study Type: Observational
• Enrollment (Actual): 1408

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The patients who meet the inclusion criteria and who were registered to this study within 14 days including the start date of treatment with this product will be subjects for this study

Description

Inclusion Criteria:

• Patients with no experience of using this product who will be administered this product for the first time

Exclusion Criteria:

• Exclusion criteria are not provided in this study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
venlafaxine; Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first	Drug: venlafaxine; The usual adult starting dosage for oral use is 37.5 mg of venlafaxine once daily, which is increased to 75 mg once daily after a meal from 1 week later. The dose may be adjusted within a range not exceeding 225 mg/day according to the patient's age and symptoms. However, the dose should be increased by 75 mg/day at intervals of not less than 1 week.; Other Names: Effexor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Drug Reactions	An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Effexor in a participant who received Effexor. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Effexor was assessed by the physician.	12 weeks from the start date (up until 52 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points	HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or from 0 to 4 (9 items), and the total score ranges from 0 to 52, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.	12 weeks from the start date ( up until 52 weeks)
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points	MADRS is a clinician-administered rating scale that assesses the overall severity of depressive symptoms. The MADRS had a 10-item checklist (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are scored from 0 to 6, and the total score ranges from 0 to 60, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.	12 weeks from the start date ( up until 52 weeks)
Clinical Global Impressions-Severity	CGI-S is a 7-point clinician-administered rating scale that assesses overall severity of the current illness state. The score ranges from 1 to 7, higher scores indicating more affected: "1: normal, not at all ill," "2: borderline mentally ill," "3: mildly ill," "4: moderately ill," "5: markedly ill," "6: severely ill," or "7: among the most extremely ill patients." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.	12 weeks from the start date (up until 52 weeks)
Changes in the Clinical Global Impressions-Improvement	CGI-I is a 7-point clinician-administered rating scale that assesses overall improvement of the disease/condition. The score ranges from 1 to 7, higher scores indicating more affected: was assessed as "1: markedly improved," "2: moderately improved," "3: mildly improved," "4: no change," "5: slightly worsened," "6: worsened," or "7: severely worsened." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.	12 weeks from the start date (up until 52 weeks)

Collaborators and Investigators

• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2016
• Primary Completion (Actual): May 11, 2020
• Study Completion (Actual): May 11, 2020

Study Registration Dates

• First Submitted: October 14, 2016
• First Submitted That Met QC Criteria: November 4, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): May 22, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2023
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Depression; Effexor; Depressed state
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Antidepressive Agents, Second-Generation; Serotonin and Noradrenaline Reuptake Inhibitors; Venlafaxine Hydrochloride
• Other Study ID Numbers: B2411278

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.