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Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder (the Orion Trial) (Orion)

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ClinicalTrials.gov Identifier: NCT01360866
Recruitment Status : Completed
First Posted : May 26, 2011
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
To assess the long-term safety and tolerability of oral OPC-34712 (brexpiprazole), given in addition to an FDA approved antidepressant (ADT) for the treatment of adults with Major Depressive Disorder (MDD)

Condition or disease Intervention/treatment Phase
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Drug: OPC-34712 Drug: Escitalopram Drug: Fluoxetine Drug: Paroxetine CR Drug: Sertraline Drug: Duloxetine Drug: Venlafaxine XR Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2944 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term, Phase 3, Multicenter, Open-label Trial to Evaluate the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adults With Major Depressive Disorder, the Orion Trial
Actual Study Start Date : October 2011
Actual Primary Completion Date : April 18, 2017
Actual Study Completion Date : May 18, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: OPC-34712 (Brexpiprazole) and Escitalopram
OPC-34712: Oral tablet; 0.5 to 3 mg/day Escitalopram: Oral tablet; 10 or 20 mg/day
Drug: OPC-34712
Tablet

Drug: Escitalopram
Tablet
Other Name: Lexapro

Experimental: OPC-34712 and Fluoxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Fluoxetine: Oral capsules; 20 or 40 mg/day
Drug: OPC-34712
Tablet

Drug: Fluoxetine
Capsule
Other Name: Prozac

Experimental: OPC-34712 and Paroxetine CR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Paroxetine CR: Oral controlled-release tablets; 37.5 or 50 mg/day
Drug: OPC-34712
Tablet

Drug: Paroxetine CR
Controlled-release tablets
Other Name: Paxil CR

Experimental: OPC-34712 and Sertraline
OPC-34712: Oral tablet; 0.5 to 3 mg/day Sertraline: Oral tablets; 100, 150, or 200 mg/day
Drug: OPC-34712
Tablet

Drug: Sertraline
Tablets
Other Name: Zoloft

Experimental: OPC-34712 and Duloxetine
OPC-34712: Oral tablet; 0.5 to 3 mg/day Duloxetine: Oral delayed-release capsules; 40 or 60 mg/day
Drug: OPC-34712
Tablet

Drug: Duloxetine
Delayed-release capsules
Other Name: Cymbalta

Experimental: OPC-34712 and Venlafaxine XR
OPC-34712: Oral tablet; 0.5 to 3 mg/day Venlafaxine XR: Oral extended-release capsules; 75, 150, or 225 mg/day
Drug: OPC-34712
Tablet

Drug: Venlafaxine XR
Extended-release capsules
Other Name: Effexor XR




Primary Outcome Measures :
  1. Adverse Events (AEs) - All Participants [ Time Frame: From screening to week 52/early termination ]
    To assess the frequency and severity of AEs as the variables of safety and tolerability of brexpiprazole.


Secondary Outcome Measures :
  1. Mean Change From Baseline in Clinical Global Impression - Severity (CGI-S) of Illness Score [ Time Frame: From screening to week 52/early termination ]
    The severity of illness for each participant was rated using the CGI-S . On the basis of the investigator answer to the question: "Considering your total clinical experience with this particular population, how mentally ill was the participant at that time?" Response choices included: 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; and 7 = among the most extremely ill participants.

  2. Change From Baseline in Mean Clinical Global Impression - Improvement (CGI-I) Score [ Time Frame: From screening to week 52/early termination ]
    The efficacy of trial treatment was rated for each participant using the CGI-I. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. All responses were compared to the participant's condition at screening. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse and 7 = very much worse.

  3. Summary of Mean Change From Baseline in Sheehan Disability Scale (SDS) Mean Score [ Time Frame: From screening to week 52/early termination ]

    The SDS was a self-rated instrument used to measure the effect of the participant's symptoms on regular life responsibilities. The SDS was a visual analogue scale that used spatio-visual, numeric, and verbal descriptive anchors simultaneously to assess disability across the 3 domains with scores from 0 = not at all, to 10 = extremely.

    Scores of 5 and above were associated with significant functional impairment.


  4. Change From Baseline in the Inventory of Depressive Symptomatology - Self Report (IDS-SR) Total Score [ Time Frame: From screening to week 52/early termination ]

    The IDS-SR was a 30-item self-report measure used to assess core diagnostic depressive symptoms as well as atypical and melancholic symptom features of MDD. The IDS-SR consists of 30 items, all rated on a 0 to 3 scale with 0 being the "best" rating and 3 being the "worst" rating. The IDS-SR Total Score is the sum of ratings of 28 item scores. The possible IDS-SR Total Score ranges from 0 (best) to 84 (worst).

    Under item 9, two sub-items 9A and 9B exist, with possible scores of 1, 2 or 3 for item 9A, and 0 or 1 for item 9B. The scores for these two sub-items are not included in the calculation of the total score. Item 11 or item 12 should be completed but not both, and similarly, item 13 or item 14 should be completed but not both. If the number of items recorded is at least 23 and at most 27, the IDS-SR Total Score will be the mean of the recorded items multiplied by 28 and then rounded to the first decimal place.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male and Female outpatients 18-65 years of age

Eligible subjects from Trials 331-10-227, 331-10-228 or 331-12-282:

  • Subjects who completed participation in the Double-blind Randomization Phase (i.e. Week 14 visit) in Trial 331-10-227, Trial 331-10-228, or Trial 331-12-282 or
  • Subjects who met criteria for a response, but did not meet criteria for remission at Week 14 of either trial

Eligible subjects from other Phase 3, Double-blind, Brexpiprazole MDD trials:

• Subjects who completed the last scheduled visit of the prior Double-blind Randomized Phase 3 trial.

Exclusion Criteria:

  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving OPC-34712.
  • Subjects with a major protocol violation during the course of their participation in the Double-blind Randomization Phase

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01360866


  Show 144 Study Locations
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
  Study Documents (Full-Text)

Documents provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Study Protocol  [PDF] June 13, 2014
Statistical Analysis Plan  [PDF] May 25, 2017


Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT01360866     History of Changes
Other Study ID Numbers: 331-10-238
First Posted: May 26, 2011    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
OPC-34712
brexpiprazole
Major Depressive Disorder
Adjunctive Treatment

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Depressive Disorder, Major
Mental Disorders
Psychotic Disorders
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Schizophrenia Spectrum and Other Psychotic Disorders
Citalopram
Sertraline
Fluoxetine
Paroxetine
Venlafaxine Hydrochloride
Duloxetine Hydrochloride
Dexetimide
Brexpiprazole
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents