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Depressive Disorder, MajorPhase 4NCT00401726

Open-Label, Randomized Study Evaluating Treatment With Venlafaxine Extended-Release Plus Dialogues Time to Talk Program

A Phase 4 study testing Venlafaxine ER and Dialogues Time to Talk Program in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer at 44 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depressive Disorder, Major
What is being tested?
Venlafaxine ER and Dialogues Time to Talk Program
How many people
537 participants
Where
44 sitesUnited States
Study dates
Jun 2006to Oct 2007
Phase
Phase 4
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

Who may be able to join

  • Currently experiencing a major depressive episode, which requires the initiation of antidepressant drug treatment or a change in current antidepressant drug treatment
  • At least 18 years of age

Who cannot join

  • History or presence of bipolar disorder
  • Current treatment with venlafaxine

Trial locations and contacts

44 sites in 1 country.

44 sites in 1 country

United States44 sites

  • Study site

    Allentown, Pennsylvania, 18104

  • Study site

    Anderson, South Carolina, 29621

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Avon, Connecticut, 06001

  • Study site

    Benzonia, Michigan, 49616

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Birmingham, Alabama, 35235

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Cartersville, Georgia, 30120

  • Study site

    Charleston, West Virginia, 25301

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Charlotte, North Carolina, 28262

  • Study site

    Chesterfield, Missouri, 63017

  • Study site

    Cincinnati, Ohio, 45236

  • Study site

    Columbus, Ohio, 43212

  • Study site

    Cromwell, Connecticut, 06416

  • Study site

    Dallas, Texas, 75235

  • Study site

    Fort Worth, Texas, 76135

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Idaho Falls, Idaho, 83404

  • Study site

    Interlochen, Michigan, 49643

  • Study site

    Kalamazoo, Michigan, 49009

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Las Vegas, Nevada, 89146

  • Study site

    Little Rock, Arkansas, 72211

  • Study site

    Mason, Ohio, 45040

  • Study site

    Mesa, Arizona, 85206

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Mogadore, Ohio, 44260

  • Study site

    Newburgh, Indiana, 47630

  • Study site

    Newtown, Pennsylvania, 18940

  • Study site

    Ocala, Florida, 34471

  • Study site

    Omaha, Nebraska, 68134

  • Study site

    Pinellas Park, Florida, 33781

  • Study site

    Plano, Texas, 75093

  • Study site

    Reading, Pennsylvania, 19606

  • Study site

    Rome, Georgia, 30165

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Jose, California, 95128

  • Study site

    Stuart, Florida, 34996

  • Study site

    Warwick, Rhode Island, 02886

  • Study site

    Waterloo, Iowa, 50702

  • Study site

    Wilmington, Delaware, 19805

Other trials in United States

About this study

Official title: Patient Outcomes With Education, Drug Therapy, and Support (POETS): A Multicenter, Open-label, Randomized Study to Evaluate Depressed Subjects Treated With Venlafaxine Extended-release vs. Venlafaxine Extended-release Plus the Dialogues Time to Talk Program in a Primary Care Setting

The purpose of this study is to evaluate the effect of the Dialogues Time to Talk program in subjects treated with Venlafaxine Extended Release (ER). Dialogues Time to Talk Program is a patient management program, which aims to help patients achieve successful outcomes by reinforcing physician treatment efforts, providing feedback to treating physicians, and encouraging better physician-patient communications.

Being tested
Venlafaxine ER, Dialogues Time to Talk Program
Keywords
Major Depressive Disorder, Depression, Anxiety
Medical subject headings
Depressive Disorder, Major, Depression, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Venlafaxine ERDrug

  • Dialogues Time to Talk ProgramBehavioural

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS)

    Patient satisfaction with depression care treatment was evaluated by patient self-assessment using the SDCS, a 10-point visual analog scale (0=not at all satisfied, 10=extremely satisfied). "Very satisfied" was defined as a score of greater than or equal to 8.

    Measured: 112 days

Secondary outcomes (7)

  1. Change in 17-item Hamilton Depression Scale Score From Baseline to 16 Weeks

    HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with major depression. Items are scored on a 0 to 2 or 4 scale (0 = none/absent and 4 = most severe) with a maximum total score of 50. Change = 16 week adjusted mean HAM-D17 score minus baseline.

    Measured: Baseline and 112 days

  2. Patient Global Impression of Improvement (PGI-I) Score

    PGI-I is a global rating scale that measures disease improvement. Using a 7-point scale (1=very much improved, 7=very much worse), the patients rate how much their illness has improved or worsened relative to their baseline status.

    Measured: 112 days

  3. Change in WHO 5-item Well Being Index Score From Baseline to 16 Weeks

    WHO 5-item Well Being Index (WHO-5) evaluates positive psychological well-being. WHO-5 consists of 5 questions and each is rated on a 6-point scale. The total score ranges from 0 to 25 (0=worst possible quality of life, 25=best possible quality of life). Change = 16 week adjusted mean WHO-5 score minus baseline.

    Measured: Baseline and 112 days

  4. Number of Patients Compliant With Therapy

    Patient compliance with therapy was assessed using a Medical Adherence Questionnaire (MAQ). MAQ consisted of 5 levels of compliance with taking medicine: Never miss, Sometimes miss, Miss half of the time, Miss most of the time, Always miss. Compliance with therapy was defined as a response of "Never miss" or "Sometimes miss".

    Measured: 112 days

  5. Change in Inventory of Depressive Symptomatology - Self-Report (IDS-SR) Score From Baseline to 16 Weeks

    IDS-SR is a patient self-administered tool used to measure the severity of depressive symptoms. Each symptom is assessed on a scale of 0 to 3 (0=absence of symptom to 3=sever symptom) for a total maximum score of 84.

    Measured: Baseline and 112 days

  6. Change in Sheehan Disability Scale Score From Baseline to 16 Weeks

    The Sheehan Disability Scale is a self-administered tool that measures functional impairment in 3 domains: Work/School, Social Life and Family Life/Home Responsibilities. The patient rates the extent to which each of these domains are impaired by his/her symptoms using a 10 point visual analog scale: (0=not at all impaired and 10=extremely impaired) for a total maximum score of 30.

    Measured: Baseline and 112 days

  7. Number of Patients by Clinical Global Improvement - Global Improvement Score at 16 Weeks

    CGI-I is a global rating scale that measures disease improvement. Using a 7-point scale, the clinician rates how much the patient's illness has improved or worsened relative to the baseline status (1=very much improved, 7=very much worse).

    Measured: 112 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Nov 2006 (estimated)
  2. Study startJun 2006
  3. Study completionOct 2007

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
537 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00401726
Sponsor's protocol ID
0600B1-416
Status last verified
Apr 2012
First submitted
17 Nov 2006
Last updated
23 Apr 2012

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Venlafaxine ER and Dialogues Time to Talk Program in people with Depressive Disorder, Major, run by Wyeth is now a wholly owned subsidiary of Pfizer at 44 sites 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 2 inclusion and 2 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 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites 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?

Yes. Results are posted in the registry (first posted 29 Jun 2010). 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 Patients Responding "Very Satisfied" on Satisfaction With Depression Care Scale (SDCS) (time frame: 112 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00401726.

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 23 Apr 2012; AzTrials last refreshed its copy on 26 Oct 2026.

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