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Trial record 50 of 64 for:    brexpiprazole

A Study of Flexible Dose Brexpiprazole as Monotherapy or Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03033069
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : January 4, 2019
Sponsor:
Collaborator:
H. Lundbeck A/S
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief Summary:
To evaluate the safety, efficacy and tolerability of brexpiprazole (with placebo) as monotherapy or combination therapy (Zoloft) in adults with PTSD.

Condition or disease Intervention/treatment Phase
Stress Disorders, Post-Traumatic Drug: Brexpiprazole (OPC-34712) Drug: Sertraline Other: Placebo Phase 2

Detailed Description:

This trial is designed to assess the efficacy, safety and tolerability of flexible dose brexpiprazole as monotherapy or as combination therapy with Zoloft (Sertraline) in adult subjects with PTSD.

This study will consist of a continuous 12-week, double-blind treatment period with a 14-day follow-up.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 336 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo- and Active-controlled Trial of Brexpiprazole as Monotherapy or as Combination Therapy in the Treatment of Adults With Post-traumatic Stress Disorder
Actual Study Start Date : January 2017
Actual Primary Completion Date : November 8, 2018
Actual Study Completion Date : November 8, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brexpiprazole Monotherapy
Flexible dose
Drug: Brexpiprazole (OPC-34712)
Active Comparator: Brexpiprazole & Zoloft (sertaline) Combination Therapy
Flexible dose
Drug: Brexpiprazole (OPC-34712)
Drug: Sertraline
Other Name: Zoloft

Active Comparator: Zoloft (setraline) monotherapy
Flexible dose
Drug: Sertraline
Other Name: Zoloft

Placebo Comparator: Placebo
Placebo
Other: Placebo



Primary Outcome Measures :
  1. Mean change in baseline of Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) Score [ Time Frame: Baseline - Week 12 ]
    CAPS-5 is a structured interview designed to assess PTSD diagnostic status and symptoms severity as defined by the DSM-5.



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 subjects between the years of 18-65 with a diagnosis of PTSD (diagnosis can be made at screening)

Exclusion Criteria:

  • Index trauma event >15 years before screening
  • Index trauma event at age <16
  • Any traumatic event within 3 months of screening

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): NCT03033069


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Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT03033069     History of Changes
Other Study ID Numbers: 331-201-00061
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brexpiprazole
Disease
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Sertraline
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents