Depression/Depressed StateNCT02958527
Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE)
An observational study of Depression/Depressed State, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
Trial summary
SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression/Depressed State
- What is being tested?
- venlafaxine
- Type of treatment
- Pill or oral medicine
- How many people
- 1,408 participants
- Where
- No sites listed yet
- Study dates
- 3 Oct 2016to 11 May 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients with no experience of using this product who will be administered this product for the first time
Who cannot join
None listed.
About this study
Official title: DRUG USE INVESTIGATION OF EFFEXOR(REGISTERED) SR CAPSULES
SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE
Read the 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.
- Conditions
- Depression/Depressed State
- Being tested
- venlafaxine
- Keywords
- Effexor, Depression, Depressed state
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venlafaxineDrug
Also called Effexor
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.
| Study group | Role | What they receive |
|---|---|---|
| venlafaxine | Patients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first Receives: Drug: venlafaxine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks from the start date (up until 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2016 (estimated)
- Study start3 Oct 2016
- Primary completion11 May 2020
- Study completion11 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Depression/Depressed StateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02958527
- Sponsor's protocol ID
- B2411278
- Status last verified
- Jun 2021
- First submitted
- 14 Oct 2016
- Last updated
- 22 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DRUG USE INVESTIGATION OF EFFEXOR(REGISTERED) SR CAPSULES
- ClinicalTrials.gov ID
- NCT02958527
- Acronym / sponsor ID
- B2411278
- Conditions
- Depression/Depressed State
- Keywords
- Effexor, Depression, Depressed state
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,408 participants (actual)
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Oct 2016 (actual)
- Primary completion
- 11 May 2020 (actual)
- Study completion
- 11 May 2020 (actual)
- First posted
- 8 Nov 2016 (estimated)
- Results
- Posted 24 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| venlafaxine | – | Drug: venlafaxinePatients with no experience of using time Effexor(venlafaxine) who will be administered time Effexor(venlafaxine)for the first |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients with no experience of using this product who will be administered this product for the first time
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| venlafaxineAlso: EffexorThe 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. | Drug | venlafaxine |
Primary outcome
Number of Participants With Adverse Drug Reactions
Time frame: 12 weeks from the start date (up until 52 weeks)
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.
4 secondary outcomes
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points
Time frame: 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
Time frame: 12 weeks from the start date ( up until 52 weeks)
Clinical Global Impressions-Severity
Time frame: 12 weeks from the start date (up until 52 weeks)
Changes in the Clinical Global Impressions-Improvement
Time frame: 12 weeks from the start date (up until 52 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Depression/Depressed State, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Drug Reactions (time frame: 12 weeks from the start date (up until 52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.