Depressive Disorder, MajorPhase 2NCT00584974
A Safety, Efficacy and Tolerability Study of SEP-225289
A Phase 2 study testing SEP-225289 and Venlafaxine in people with Depressive Disorder, Major, run by Sumitomo Pharma America, Inc. at 51 sites in United States.
Trial summary
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- SEP-225289 and Venlafaxine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 523 participants
- Where
- 51 sitesUnited States
- Study dates
- Dec 2007to May 2009
- Phase
- Phase 2
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The duration of the current episode must be at least 1 month but not longer than 12 months.
- Subjects must have a primary diagnosis of Major Depressive Disorder.
- Subjects must have had at least one previous, diagnosed episode of MDD in the past 5 years.
- MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
- Subject is in general good health.
Who cannot join
- Subject is participating in, has participated in, or plans to participate in any investigational drug study.
- Subject who has donated blood within the last 30 days or plans to donate blood during and 30 days following participation.
- Known failure to respond (in the past 5 years) to two adequate (dose and duration) antidepressant medications with distance mechanisms of action including tricyclics.
- Subjects who have undergone Electroconvulsive Therapy treatment.
- Treatment with fluoxetine, in the 6 weeks before baseline.
- Subject with psychotic disorders, anorexia nervosa, bulimia or post-traumatic stress disorder.
Show all 14Show fewer
- Subject with a history or presence of bipolar disorder (i.e., current or past history of manic episode).
- Subjects with Obsessive Compulsive Disorder.
- Subjects with a lifetime diagnosis of Panic Disorder.
- Subject received treatment with antidepressants within 2 weeks.
- Subject with lifetime history of suicidal attempts, alcohol dependence or abuse, drug(s) dependence or abuse (excluding nicotine and caffeine) or has a positive urine drug screen.
- Subject has a history of significant risk of suicide or homicide.
- Bereavement - Defined as death of a loved one within 3 months.
- Subject has a documented history of HIV, hepatitis B or hepatitis C.
Trial locations and contacts
51 sites in 1 country.
51 sites in 1 country
United States51 sites
Study site
Albuquerque, New Mexico, 87109
Study site
Arcadia, California, 91007
Study site
Atlanta, Georgia, 30328
Study site
Atlanta, Georgia, 30341
Study site
Austin, Texas, 78756
Study site
Beverly Hills, California, 90210
Study site
Boston, Massachusetts, 02135
Study site
Bradenton, Florida, 34208
Study site
Braintree, Massachusetts, 02184
Study site
Brooklyn, New York, 11235
Study site
Cincinnati, Ohio, 45227
Study site
Clementon, New Jersey, 08021
Study site
Costa Mesa, California, 92626
Study site
Dallas, Texas, 75231
Study site
Dayton, Ohio, 45408
Study site
Denver, Colorado, 80204
Study site
Denver, Colorado, 80239
Study site
Flowood, Mississippi, 39232
Study site
Fort Myers, Florida, 33912
Study site
Garden Grove, California, 92845
Study site
Glendale, California, 91204
Study site
Houston, Texas, 77040
Study site
Irvine, California, 92618
Study site
Irving, Texas, 75062
Study site
Jacksonville, Florida, 32216
Study site
Lafayette, California, 94549
Study site
Lake Charles, Louisiana, 70601
Study site
Lauderhill, Florida, 33139
Study site
Little Rock, Arkansas, 72211
Study site
Maitland, Florida, 32751
Study site
Middleburg Heights, Ohio, 44130
Study site
Midlothian, Virginia, 23112
Study site
New Britain, Connecticut, 06050
Study site
New York, New York, 10021
Study site
New York, New York, 10023
Study site
New York, New York, 10075
Study site
North Miami, Florida, 33161
Study site
Oceanside, California, 92056
Study site
Oklahoma City, Oklahoma, 73112
Study site
Park Ridge, Illinois, 60068
Study site
Philadelphia, Pennsylvania, 19149
Study site
Portland, Oregon, 97210
Study site
Raleigh, North Carolina, 27609
Study site
Saint Charles, Missouri, 63301
Study site
San Diego, California, 92103
Study site
Sanford, Florida, 32771
Study site
Seattle, Washington, 98104
Study site
Smyrna, Georgia, 30080
Study site
The Bronx, New York, 10454
Study site
The Bronx, New York, 10467
Study site
Upland, California, 91786
About this study
Official title: A Double-Blind, Placebo-Controlled Study Examining The Safety, Efficacy, and Tolerability of SEP-225289 in Subjects With Major Depressive Disorder (Including Atypical and Melancholic Features)
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder
Read the detailed description
This is a randomized, placebo-controlled, double-dummy, multi-center study of the safety, efficacy and tolerability of SEP-225289 in male and female subjects with MDD. Subjects meeting DSM-IV criteria for Melancholic or Atypical Features specifier are eligible for participation. The study will consist of a screening period, which may last up to 2 weeks, an eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one week (7 day) follow up. Total subject participation will be approximately 91 days (13 weeks). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Depressive Disorder, Major
- Being tested
- SEP-225289, Venlafaxine, placebo
- Keywords
- Depression, Mental Disorders, Mood Disorders, Depressive Disorder, Major, Dysthymic Disorder
- Medical subject headings
- Depressive Disorder, Major, Depression, Mental Disorders, Mood Disorders, Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SEP-225289Drug
0.5 mg SEP-225289
SEP-225289Drug
2.0 mg SEP-225289
VenlafaxineDrug
Also called Effexor
150 mg Venlafaxine
placeboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg SEP-225289 | Experimental | 0.5 mg SEP-225289 Receives: Drug: SEP-225289 |
| 2.0 mg of SEP-225289 | Experimental | 2.0 mg of SEP-225289 Receives: Drug: SEP-225289 |
| Venlafaxine | Active comparator | 150 mg Venlafaxine Receives: Drug: Venlafaxine |
| Placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)
Measured: 56 days
Secondary outcomes (1)
To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features
Measured: 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive Disorder, MajorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 523 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, CNS, Study chair, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00584974
- Sponsor's protocol ID
- 360-029
- Status last verified
- Feb 2012
- First submitted
- 21 Dec 2007
- Last updated
- 23 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled Study Examining The Safety, Efficacy, and Tolerability of SEP-225289 in Subjects With Major Depressive Disorder (Including Atypical and Melancholic Features)
- ClinicalTrials.gov ID
- NCT00584974
- Acronym / sponsor ID
- 360-029
- Conditions
- Depressive Disorder, Major
- Keywords
- Depression, Mental Disorders, Mood Disorders, Depressive Disorder, Major, Dysthymic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 523 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 2 Jan 2008 (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.
To determine the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder
Detailed description
This is a randomized, placebo-controlled, double-dummy, multi-center study of the safety, efficacy and tolerability of SEP-225289 in male and female subjects with MDD. Subjects meeting DSM-IV criteria for Melancholic or Atypical Features specifier are eligible for participation. The study will consist of a screening period, which may last up to 2 weeks, an eight week (56 day) double-blind treatment period, a two week (14 day) wash-out, and a one week (7 day) follow up. Total subject participation will be approximately 91 days (13 weeks). This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg SEP-225289 | Experimental | Drug: SEP-2252890.5 mg SEP-225289 |
| 2.0 mg of SEP-225289 | Experimental | Drug: SEP-2252892.0 mg of SEP-225289 |
| Venlafaxine | Active comparator | Drug: Venlafaxine150 mg Venlafaxine |
| Placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The duration of the current episode must be at least 1 month but not longer than 12 months.
- Subjects must have a primary diagnosis of Major Depressive Disorder.
- Subjects must have had at least one previous, diagnosed episode of MDD in the past 5 years.
- MDD must be the condition that was chiefly responsible for motivating the subject to seek treatment.
- Subject is in general good health.
Key exclusion criteria (14 listed)
- Subject is participating in, has participated in, or plans to participate in any investigational drug study.
- Subject who has donated blood within the last 30 days or plans to donate blood during and 30 days following participation.
- Known failure to respond (in the past 5 years) to two adequate (dose and duration) antidepressant medications with distance mechanisms of action including tricyclics.
- Subjects who have undergone Electroconvulsive Therapy treatment.
- Treatment with fluoxetine, in the 6 weeks before baseline.
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 |
|---|---|---|
| SEP-2252890.5 mg SEP-225289 | Drug | 0.5 mg SEP-225289 |
| SEP-2252892.0 mg SEP-225289 | Drug | 2.0 mg of SEP-225289 |
| VenlafaxineAlso: Effexor150 mg Venlafaxine | Drug | Venlafaxine |
| placeboPlacebo | Drug | Placebo |
Primary outcome
To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD)
Time frame: 56 days
1 secondary outcome
To examine the response to SEP-225289 in MDD subjects meeting DSM_IV criteria for atypical and melancholic features
Time frame: 56 days
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 23 Feb 2012.
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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 Director, CNS study chair
Sumitomo Pharma America, Inc.
51 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SEP-225289 and Venlafaxine in people with Depressive Disorder, Major, run by Sumitomo Pharma America, Inc. at 51 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 5 inclusion and 14 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 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
To assess the safety, efficacy and tolerability of SEP-225289 in subjects with Major Depressive Disorder (MDD) (time frame: 56 days). 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 23 Feb 2012.