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

NCT02958527 | Completed Results

• 1 other identifier: B2411278
• Study Type: observational
• Target: 1,408
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Depression/Depressed State

Keywords

Effexor; Depression; Depressed state

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points

  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

  12 weeks from the start date ( up until 52 weeks)

• Clinical Global Impressions-Severity

  12 weeks from the start date (up until 52 weeks)

• Changes in the Clinical Global Impressions-Improvement

  12 weeks from the start date (up until 52 weeks)

Study Arms (1)

venlafaxine

Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first

Drug: venlafaxine

Interventions

venlafaxine DRUG

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.

Also known as: Effexor

venlafaxine

Eligibility Criteria

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

You may qualify if:

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

Sponsors & Collaborators

• Pfizer's Upjohn has merged with Mylan to form Viatris Inc.: lead

Related Links

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

MeSH Terms

Conditions

Depression

Interventions

Venlafaxine Hydrochloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2016
• First Posted: November 8, 2016
• Study Start: October 3, 2016
• Primary Completion: May 11, 2020
• Study Completion: May 11, 2020
• Last Updated: May 22, 2023
• Results First Posted: May 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share