DepressionPhase 3NCT00225511
Study Evaluating Effexor XR for Major Depression.
A Phase 3 study testing Effexor XR and Milnacipran in people with Depression, run by Wyeth is now a wholly owned subsidiary of Pfizer at 73 sites in Japan.
Trial summary
Study Evaluating Effexor XR for Major Depression. Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Depression
- What is being tested?
- Effexor XR and Milnacipran
- How many people
- 590 participants
- Where
- 73 sitesJapan
- Study dates
- Jun 2004to not given
- Phase
- Phase 3
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with major depression based on DSM-IV-TR
- Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" at the baseline.
Who cannot join
- Patients with schizophrenia or any other psychotic disorder
- Patients with history or presence of bipolar disorder
Trial locations and contacts
73 sites in 1 country.
73 sites in 1 country
Japan73 sites
Study site
Adachi-ku, Tokyo, 120-0033
Study site
Beppu, Ohita, 874-0011
Study site
Bunkyo-ku, Tokyo, 113-0021
Study site
Bunkyo-ku, Tokyo, 113-8603
Study site
Chiyoda-ku, Tokyo, 101-8643
Study site
Chiyoda-ku, Tokyo, 102-8161
Study site
Fukuoka, Fukuoka, 810-0001
Study site
Fukuoka, Fukuoka, 810-0801
Study site
Fukuoka, Fukuoka, 812-8582
Study site
Fukuoka, Fukuoka, 813-0044
Study site
Hamamatsu, Shizuoka, 431-3192
Study site
Hanamaki, Iwate, 025-0033
Study site
Hiroshima, Hiroshima, 730-8518
Study site
Hiroshima, Hiroshima, 731-0121
Study site
Hiroshima, Hiroshima, 734-8551
Study site
Ichikawa, Chiba, 272-0034
Study site
Ichikawa, Chiba, 272-0827
Study site
Itabashi-ku, Tokyo, 173-0015
Study site
Jyo-etsu, Niigata, 949-3193
Study site
Kanazawa, Ishikawa-ken, 920-8641
Study site
Kashihara, Nara, 634-8522
Study site
Kasuga, Fukuoka, 816-0801
Study site
Kawasaki, Kanagawa, 215-0021
Study site
Kawasaki, Kanagawa, 216-8511
Study site
Kikuchi, Kumamoto, 861-1116
Study site
Kitakyushu, Fukuoka, 802-0006
Study site
Kitakyushu, Fukuoka, 802-8555
Study site
Kitakyushu, Fukuoka, 804-0062
Study site
Kodaira, Tokyo, 187-8551
Study site
Kure, Hiroshima, 737-0023
Study site
Kurume, Fukuoka, 830-0011
Study site
Meguro-ku, Tokyo, 152-0012
Study site
Meguro-ku, Tokyo, 152-8902
Study site
Meguro-ku, Tokyo, 153-8515
Study site
Minato-ku, Tokyo, 107-0052
Study site
Minato-ku, Tokyo, 107-0062
Study site
Moriguchi, Osaka, 570-8506
Study site
Nagasaki, Nagasaki, 852-8501
Study site
Nagoya, Aichi-ken, 462-0831
Study site
Nagoya, Aichi-ken, 467-8602
Study site
Nakano-ku, Tokyo, 164-0003
Study site
Nishinomiya, Hyōgo, 662-0832
Study site
Ohmura, Nagasaki, 856-8562
Study site
Ohnojyo, Fukuoka, 816-0943
Study site
Ohta-ku, Tokyo, 143-8541
Study site
Osaka, Osaka, 530-0012
Study site
Osaka, Osaka, 545-8586
Study site
Otaru, Hokkaido, 047-0032
Study site
Sagamihara, Kanagawa, 228-0803
Study site
Sagamihara, Kanagawa, 229-1103
Study site
Saitama, Saitama, 330-0074
Study site
Sapporo, Hokkaido, 006-8555
Study site
Sapporo, Hokkaido, 060-0042
Study site
Sapporo, Hokkaido, 060-8648
Study site
Sapporo, Hokkaido, 063-0061
Study site
Sapporo, Hokkaido, 064-0946
Study site
Sapporo, Hokkaido, 065-0012
Study site
Sayama, Osaka, 589-0011
Study site
Sayama, Osaka, 589-8511
Study site
Setagaya-ku, Tokyo, 154-0004
Study site
Shinjuku, Tokyo, 160-0023
Study site
Tachikawa, Tokyo, 190-0012
Study site
Toshima-ku, Tokyo, 170-0002
Study site
Toshima-ku, Tokyo, 170-0005
Study site
Tsuchiura, Ibaragi, 300-8585
Study site
Tsukuba, Ibaragi, 305-8576
Study site
Yokohama, Kanagawa, 220-0004
Study site
Yokohama, Kanagawa, 224-8503
Study site
Yokohama, Kanagawa, 225-0012
Study site
Yokohama, Kanagawa, 236-0004
Study site
Yokohama, Kanagawa, 238-8558
Study site
Yokohama, Kanagawa, 241-0081
Study site
Yokohama, Kanagawa, 245-8575
About this study
Official title: Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression
Study Evaluating Effexor XR for Major Depression.
- Conditions
- Depression
- Being tested
- Effexor XR, Milnacipran
- Keywords
- Depression
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effexor XRDrug
MilnacipranDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
Secondary outcomes (2)
Difference of total score of HAM-D17 between baseline and final-on-therapy.
Remission rate of HAM-D17 at the final-on-therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2005 (estimated)
- Study startJun 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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00225511
- Sponsor's protocol ID
- 0600B1-816
- Status last verified
- May 2007
- First submitted
- 12 Sep 2005
- Last updated
- 24 May 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Multi-Center, Double-Blind, Comparative Study of Effexor XR for the Treatment of Depression
- ClinicalTrials.gov ID
- NCT00225511
- Acronym / sponsor ID
- 0600B1-816
- Conditions
- Depression
- Keywords
- Depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jun 2004
- First posted
- 23 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.
Study Evaluating Effexor XR for Major Depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with major depression based on DSM-IV-TR
- Patients having minimal total score of 18 on the HAM-D17 and minimal score of 2 on the item of "depressed mood" at the baseline.
Key exclusion criteria (2 listed)
- Patients with schizophrenia or any other psychotic disorder
- Patients with history or presence of bipolar disorder
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 |
|---|---|---|
| Effexor XR | Drug | – |
| Milnacipran | Drug | – |
Primary outcome
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.
2 secondary outcomes
Difference of total score of HAM-D17 between baseline and final-on-therapy.
Remission rate of HAM-D17 at the final-on-therapy.
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 24 May 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
73 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Effexor XR and Milnacipran in people with Depression, run by Wyeth is now a wholly owned subsidiary of Pfizer at 73 sites in Japan.
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 24 May 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 73 sites in Japan. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Response rate of HAM-D17 (Hamilton Rating Scale for Depression) at the final-on-therapy.. 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 24 May 2007.