Completed
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
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What is being tested
venlafaxine-XR
Drug
Who is being recruted
Depression
Over 60 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed
Treatment Study
Phase 4
Interventional
Study Start: October 2000
See protocol details
Summary
Principal SponsorUniversity of Pittsburgh
Last updated: October 9, 2008
Sourced from a government-validated database.Claim as a partner
Study start date: October 1, 2000Actual date on which the first participant was enrolled.
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.
The primary objective of this pilot study is to evaluate the safety of venlafaxine extended release formulation (XR) in the treatment of geriatric non-psychotic depression. This pilot study's specific aims are to assess the safety of venlafaxine XR in the geriatric population, to estimate the response rate of older depressed subjects treated under open conditions and to evaluate pharmacokinetic characteristics that may impact on safety and outcome.
Principal SponsorUniversity of Pittsburgh
Last updated: October 9, 2008
Sourced from a government-validated database.Claim as a partner
ProtocolThis section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
70 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
How participants are assigned to different groups/arms
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
In this clinical study, participants are assigned to groups based on specific criteria, such as their medical history or a doctor's recommendation. This approach ensures that treatments are given to those who may benefit the most, based on known factors.
Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.
How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.
Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.
How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.
Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.
EligibilityResearchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 60 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Depression
Criteria
4 inclusion criteria required to participate
men and women of all races who are 60 years old or older
a DSM-IV diagnosis of major depressive episode without psychotic features
17-item Ham-D score of >15 for potential subjects who have not received any antidepressant treatment during this illness episode or HAM-D \> 11 for potential subjects who have received treatment with an antidepressant (other than venlafaxine-XR) during this illness episode
a MMSE score of >15
8 exclusion criteria prevent from participating
history of meeting DSM-IV criteria for mania, schizophrenia or other psychotic disorder
history of substance abuse or dependence, including alcohol, within the last three months
current hyponatremia (as defined as a serum sodium level < 130 meq/l)
untreated or uncontrolled hypertension
Show More Criteria
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Study PlanFind out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives
Study Objectives
Primary Objectives
Secondary Objectives
Study CentersThese are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
CompletedOne Study Center