A Phase 3 Trial Investigating the Long-term Safety and Tolerability of OPC-34712 in the Treatment of Adults with Major Depressive Disorder
- Conditions
- Major Depressive Disorder (MDD)MedDRA version: 19.1Level: LLTClassification code 10025454Term: Major depressive disorder, recurrent episodeSystem Organ Class: 100000004873Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- EUCTR2011-001351-37-DE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 3000
Subjects are required to meet the following inclusion criteria:
1. Subjects who are able to provide written informed consent and/or
consent obtained from a legally acceptable representative (as required
by IRB/IEC) prior to the initiation of any protocol-required procedures.
2. Ability, in the opinion of the principal investigator, to understand the
nature of the trial and follow protocol requirements, including the
prescribed dosage regimens, tablet/capsule ingestion, and
discontinuation of prohibited concomitant medication; to read and
understand the written word in order to complete subject-reported
outcomes measures; and to be reliably rated on assessment scales.
3. 331-10-227, 331-10-228 and 331-13-214 Subjects Only- Subjects
who, in the opinion of the investigator, could potentially benefit from
administration of brexpiprazole as adjunctive therapy to their
antidepressant therapy and who meet one of the following criteria:
a) Subjects who completed participation in the Double-blind
Randomization Phase (ie, Week 14 visit of Phase B) in Trials 331-10-
227, 331-10-228 or 331-13-214
b) Subjects who continued into Phase A+ at the end of prospective
treatment (ie, Week 8 visit of Phase A) in Trial 331-10-227, 331-10-228
or 331-13-214 , BUT DID NOT meet criteria for remission (defined as a
MADRS Total Score of = 10) at the Week 14 visit of Phase A+ in Trial
331-10- 227, 331-10-228 or 331-13-214 .
4. Eligible Subjects From Other Double-Blind Phase 3 Brexipiprazole MDD
Trials: Subjects who completed the last scheduled visit of the prior
double-blind phase 3 trial, and who in the opinion of the investigator,
could potentially benefit from administration of brexpiprazole as
adjunctive therapy to their antidepressant therapy
5.Male and female outpatients 18 to 65 years of age, inclusive, at the
time of informed consent for Trial 331-10-238.
6. Subjects willing to discontinue all prohibited psychotropic medications
starting from the time of signing the ICF and during the trial period.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2880
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 120
For full details on exclusion criteria please refer to Section 3.4.3 of the
trial protocol.
Subjects will be excluded if they meet any of the following selected
exclusion criteria:
1. Sexually active females of childbearing potential and male subjects
who are not practicing two different methods of birth control with their
partner during the trial and for 30 days after the last dose of trial
medication or who will not remain abstinent during the trial and for 30
days after the last dose.
2. Females who are breast-feeding and/or who have a positive
pregnancy test result prior to receiving open-label OPC-34712 in Trial
331-10-238.
3. Subjects with a major protocol violation during the course of their
participation in the prior double-blind phase 3 trial.
4. Subjects who have received ECT for the current depressive episode.
5. Subjects who have had an inadequate response to ECT at any time in
the past or who have had a vagus nerve stimulation or deep brain
stimulation device implanted for management of treatment resistant
depression. Subjects who have had Transcranial Magnetic Stimulation
during the current major depressive episode
6. Subjects with a current need for involuntary commitment or who have
been hospitalized during the prior double-blind phase 3 trial for the
current major depressive episode.
7. 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
8. Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline,
antisocial, paranoid, schizoid, schizotypal or histrionic personality
disorder.
9. Subjects experiencing hallucinations, delusions or any psychotic
symptomatology in the current depressive episode.
10. Subjects receiving new onset psychotherapy (individual, group,
marriage, or family therapy) during the prior double-blind phase 3 trial.
11. Prisoners or subjects who are compulsorily detained (involuntarily
incarcerated) for treatment of either a psychiatric or physical (eg,
infectious disease) illness must not be enrolled into this trial.
12. Any subject who, in the opinion of the investigator, should not
participate in the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess the long-term safety and tolerability of oral OPC-34712 as adjunctive therapy in the treatment of adults with MDD.;Secondary Objective: To assess the long-term efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adults with MDD.;Primary end point(s): The primary outcome variable is the safety and tolerability of OPC-34712 which will be assessed by examining the frequency and severity of adverse events (AEs).;Timepoint(s) of evaluation of this end point: The primary endpoint will be evaluated using data collected throughout by trial week and at the last visit (week 26/early termination). The final evaluation of the data will be completed following the last visit of the last patient enrolled on the study.
- Secondary Outcome Measures
Name Time Method