Major Depressive DisorderPhase 2NCT01447576
Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder
A Phase 2 study testing ADT and OPC-34712 in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 32 sites in United States.
Trial summary
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- ADT and OPC-34712
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,036 participants
- Where
- 32 sitesUnited States
- Study dates
- Sep 2009to Dec 2012
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
- Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
- Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments.
Who cannot join
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
- Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder.
- Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
Pacific Clinical Research Medical Group
Arcadia, California, 91007
Pharmasite Research
Baltimore, Maryland, 91208
Northwest Clinical Research Center
Bellevue, Washington, 98007
Brooklyn Medical Institute
Brooklyn, New York, 11214
Northbrooke Research Center
Brown Deer, Wisconsin, 53223
Psychiatric Alliance of the Blue Ridge
Charlottesville, Virginia, 22903
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
Carolina Clinical Research Services
Columbia, South Carolina, 29201
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Gulfcoast Clinical Research Center
Fort Myers, Florida, 33912
Clinical Insights
Glen Burnie, Maryland, 21061
Neuroscience, Inc.
Herndon, Virginia, 20170
Bayou City Research, Ltd.
Houston, Texas, 77007
Goldpoint Clinical Research, LLC
Indianapolis, Indiana, 46240
Clinical Neuroscience Solutions
Jacksonville, Florida, 32216
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
Florida Clinical Research Center
Maitland, Florida, 32751
Dean Foundation
Middleton, Wisconsin, 53562
Radiant Research
Murray, Utah, 84123
Medical & Behavioral Health Research
New York, New York, 10023
The Medical Research Network, LLC
New York, New York, 10128
Clinical Neurosciences Solutions
Orlando, Florida, 32806
Oregon Center for Clinical Investigations, Inc.
Portland, Oregon, 97210
Finger Lakes Clinical Research
Rochester, New York, 14618
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Oregon Center for Clinical Investigations
Salem, Oregon, 97301
Artemis Institute for Clinical Research
San Diego, California, 92123
Summit Research Network
Seattle, Washington, 98104
California Neuroscience Research Medical Group, Inc.
Sherman Oaks, California, 91403
Carman Research
Smyrna, Georgia, 30080
Stedman Clinical Trials
Tampa, Florida, 33613
About this study
Official title: A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
- Conditions
- Major Depressive Disorder
- Being tested
- ADT, OPC-34712
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADTDrug
Also called Anti-depressant Drug Therapy
Once daily dosing during the duration of the study.
OPC-34712Drug
OPC-34712, Oral Tablets, 0.25 - 3 mg
| Study group | Role | What they receive |
|---|---|---|
| OPC-34712 + ADT | Experimental | Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment Receives: Drug: ADT; Drug: OPC-34712 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Adverse Events (AEs).
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
Measured: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit
Secondary outcomes (2)
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
The CGI-S is a 7-point scale from 1 through 7. The items on CGI-S scale are: 0 = not assessed, 1 = normal, not at all ill, 2 = borderline mentally ill, 3 = mildly ill, 4 = moderately ill, 5 = markedly ill, 6 = severely ill, 7 = among the most extremely ill participants. The score 0 (= not assessed) was set to missing.
Measured: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
The items on CGI-I scale are 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, 7 = very much worse. The score of 0 (= not assessed) was set to missing. The CGI-I is therefore a 7-point scale from 1 through 7. CGI improvement was compared to the participants condition at Baseline.
Measured: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2011 (estimated)
- Study startSep 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,036 participants (actual)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01447576
- Sponsor's protocol ID
- 331-08-212
- Status last verified
- Oct 2015
- First submitted
- 29 Sep 2011
- Last updated
- 6 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT01447576
- Acronym / sponsor ID
- 331-08-212
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,036 participants (actual)
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 6 Oct 2011 (estimated)
- Results
- Posted 6 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OPC-34712 + ADT | Experimental | Drug: ADT, Drug: OPC-34712Experimental: OPC-34712, Oral Tablets, 0.25 - 3 mg; Antidepressant drug treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects between 18 and 65 years of age, with a diagnosis of a single or recurrent, non-psychotic episode of major depressive disorder, as defined by DSM-IV-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (M.I.N.I.) which is equal to or greater than 8 weeks in duration.
- Subjects must currently be taking allowable antidepressant therapy at an adequate dose for a minimum of six weeks by the end of the screening period (ie at the time of the Baseline visit).
- Subjects must report a history for the current depressive episode of an inadequate response to at least one and no more than four adequate antidepressant treatments.
Key exclusion criteria (4 listed)
- Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug.
- Subjects who report an inadequate response to more than three adequate trials of antidepressant treatments during current depressive episode at a therapeutic dose for an adequate duration.
- Subjects with a current Axis I (DSM-IV-TR) diagnosis of: Delirium, dementia,amnestic or other cognitive disorder Schizophrenia, schizoaffective disorder, or other psychotic disorder Bipolar I or II disorder, eating disorder (including anorexia nervosa or bulimia), obsessive compulsive disorder, panic disorder, post-traumatic stress disorder.
- Subjects with a clinically significant current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality 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 |
|---|---|---|
| ADTAlso: Anti-depressant Drug TherapyOnce daily dosing during the duration of the study. | Drug | OPC-34712 + ADT |
| OPC-34712OPC-34712, Oral Tablets, 0.25 - 3 mg | Drug | OPC-34712 + ADT |
Primary outcome
Participants With Adverse Events (AEs).
Time frame: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug-related by the physician. The severity was assessed as mild, moderate, or severe. A treament-emergent AE (TEAE) was defined as any AE that started after start of open-label brexpiprazole; or if the event was continuous from baseline and was worsening, serious, study drug-related, or resulted in death, discontinuation, interruption, or reduction of study drug.
2 secondary outcomes
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Scale Score.
Time frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (last-observation-carried-forward [LOCF])
Mean Clinical Global Impression - Improvement (CGI-I) Scale Score.
Time frame: Week 1, 2, 4, 6, 8, 14, 20, 26, 32, 38, 44, 52 and 52 (LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
32 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 ADT and OPC-34712 in people with Major Depressive Disorder, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 32 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 3 inclusion and 4 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 6 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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 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?
Yes. Results are posted in the registry (first posted 6 Nov 2015). 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?
Participants With Adverse Events (AEs). (time frame: After the Informed Consent Form (ICF) was signed, through Follow up 30 (+2) days after last visit). 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 6 Nov 2015.