DepressionPhase 4NCT00177528
Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
A Phase 4 study testing venlafaxine-XR in people with Depression, run by University of Pittsburgh at 1 site in United States.
Trial summary
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- venlafaxine-XR
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2000to Nov 2004
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
- a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
- history of receiving venlafaxine-XR or venlafaxine immediate release formulation of 6 or more weeks at 300mg/d during index depressive episode; (7) EKG revealing QTc > 480 msec;
- myocardial infarction, unstable angina, palpitation or cardiogenic syncope within 3 months prior to entering this study;
- the presence of active suicidal ideation with intent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.
Read the detailed description
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.
- Conditions
- Depression
- Being tested
- venlafaxine-XR
- Keywords
- Elderly
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
venlafaxine-XRDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of venlafaxine XR.
Rate of Major Depression remission to treatment.
Secondary outcomes (1)
Participant characteristics that influence safety and remission rate.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startOct 2000
- Primary completionNov 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Investigators
- Ellen M Whyte, MD, Principal investigator, University of PittsburghBenoit H Mulsant, MD, Principal investigator, University of PittsburghCharles F. Reynolds III, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177528
- Sponsor's protocol ID
- 000918
- Status last verified
- Oct 2008
- First submitted
- 13 Sep 2005
- Last updated
- 9 Oct 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Venlafaxine XR in Elderly Patients With Major Depression
- ClinicalTrials.gov ID
- NCT00177528
- Acronym / sponsor ID
- 000918
- Conditions
- Depression
- Keywords
- Elderly
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2000
- Primary completion
- Nov 2004 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is to evaluate the safety and usefulness of venlafaxine-XR in the treatment of major depression in the elderly.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
- a history of being unable to tolerate venlafaxine-XR or venlafaxine immediate release formulation;
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 |
|---|---|---|
| venlafaxine-XR | Drug | – |
Primary outcome
The safety and tolerability of venlafaxine XR.
Rate of Major Depression remission to treatment.
1 secondary outcome
Participant characteristics that influence safety and remission rate.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2008.
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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.
Ellen M Whyte, MD principal investigator
University of Pittsburgh
Benoit H Mulsant, MD principal investigator
University of Pittsburgh
Charles F. Reynolds III, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing venlafaxine-XR in people with Depression, run by University of Pittsburgh at 1 site in United States.
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 4 inclusion and 8 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 9 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The safety and tolerability of venlafaxine XR.. The study lists 2 primary outcomes in all. 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 9 Oct 2008.