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Aripiprazole IM Depot in the Acute Treatment of Adults With Schizophrenia

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ClinicalTrials.gov Identifier: NCT03172871
Recruitment Status : Recruiting
First Posted : June 1, 2017
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Beijing Research Institute

Brief Summary:
This is a phase 3, multicenter, randomized, active-controlled trial to assess the efficacy and safety of aripiprazole Intramuscular Depot in the acute treatment of adults with schizophrenia. The trial will include a 13-day screening phase and a 12-week acute treatment phase with a 14(±2)-day safety follow-up.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Aripiprazole IM Depot Drug: Aripiprazole tablet Phase 3

Detailed Description:

Screening Phase: The screening phase will begin when informed consent is signed and be a maximum of 13 days. The investigators will assess the subjects who meet all eligibility criteria and collect the characteristic information of the subjects, such as demographic, medical history, etc. If subjects have been exposed to aripiprazole in the past (ie, tolerability has been established), then subjects will enter a washout period for 3~7 days from prior antipsychotic medications and other prohibited concomitant medications. If the investigator may reasonably verify that subject has been off antipsychotics for at least 3~7 days and has a history of tolerating aripiprazole, then the subject may have a screening phase of < 7 days as long as the subject has had at least a 3~7-day washout phase from other antipsychotic medications. Subjects are required to be hospitalized during the entire screening phase.

12-week Acute Treatment Phase: At baseline, eligible subjects will be randomized in a 1:1 ratio to either aripiprazole IM depot or aripiprazole tablet. For 14 days beginning with the first injection, subjects randomized aripiprazole IM depot will receive concomitant oral aripiprazole and subjects randomized to aripiprazole tablet will receive 12 weeks concomitant injection placebo.

Safety Follow-up Phase: All subjects will be followed-up for safety via telephone contact 14(±2) days after the last trial visit.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 430 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-blind, Active-Controlled Study to Evaluate the Efficacy and Safety of Aripiprazole Intramuscular Depot in the Acute Treatment of Adults With Schizophrenia
Actual Study Start Date : May 15, 2017
Estimated Primary Completion Date : July 28, 2019
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Aripiprazole IM Depot

Aripiprazole IM depot group (Aripiprazole IM Depot):

The first 2 weeks of the acute treatment phase IM Injection 400 mg every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase IM Injection 400/300 mg every 4 weeks + placebo(tablets)(once a day)

Drug: Aripiprazole IM Depot
Aripiprazole IM depot 400 mg/300 mg (when not tolerated)
Other Name: Aripiprazole Intramuscular Depot
Drug: Aripiprazole tablet
Oral aripiprazole tablets 10 to 20 mg daily
Other Name: Aripiprazole TAB
Active Comparator: Aripiprazole tablet

Oral aripiprazole group (Aripiprazole tablet):

The first 2 weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day After the first two weeks of the acute treatment phase Placebo (Injection) every 4 weeks + Aripiprazole tablets 10-20 mg per day

Drug: Aripiprazole IM Depot
Aripiprazole IM depot 400 mg/300 mg (when not tolerated)
Other Name: Aripiprazole Intramuscular Depot
Drug: Aripiprazole tablet
Oral aripiprazole tablets 10 to 20 mg daily
Other Name: Aripiprazole TAB



Primary Outcome Measures :
  1. Mean change from baseline to endpoint(10th week)in PANSS Total Score. [ Time Frame: 1st,2nd,4th,6th,8th,10th,12th week ]
    The primary efficacy outcome variable is mean change from baseline to endpoint (Week 10) in PANSS Total Score. The objective of the primary analysis is to compare the efficacy of aripiprazole IM depot (400 mg or 300 mg) with that of placebo with regard to mean change from baseline to endpoint (Week 10) in PANSS Total Score.



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

Inclusion Criteria:

  1. Provide written informed consent form by subjects or subject's legal representative.
  2. Ability to understand the nature of the trial, agree to comply with the prescribed medication and dosage regimens, complete the schedule visit, report the adverse event and concomitant medication to investigator, and to be reliably rated on psychiatrically scales.
  3. Male and female subjects 18 to 65 years of age, at the time of informed consent.
  4. Subjects with a diagnosis of schizophrenia for at least 1 year as defined by DSM-IV-TR criteria and confirmed by the MINI for Schizophrenia and Psychotic Disorders Studies.
  5. Subjects with a stable living environment when not in hospital, as demonstrated by the ability to provide contact information for themselves and/or family/friend(s)/caregiver(s).
  6. Subjects who are experiencing an acute exacerbation of psychotic symptoms
  7. Subjects who have received previous outpatient antipsychotic treatment at an adequate dose (minimal recommended dose for the treatment of schizophrenia according to the manufacturer labeling) for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months, according to the investigator's opinion.
  8. Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment, excluding the current episode.
  9. Subjects willing to discontinue all prohibited psychotropic medications to meet protocol- required washouts prior to and during the trial period.

Exclusion Criteria:

  1. Women subjects or men subjects whose partner are possibly pregnant, or wish to become pregnant, within 1 year after signing informed consent form.
  2. Women who are pregnant or breastfeeding.
  3. Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessments.
  4. Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized > 5 days for the current acute episode at the time of the screening visit (ie, signing the informed consent).
  5. Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment by history of failure to respond to 2 adequate trials with different antipsychotic medications with a minimum of 6 weeks at clinically efficacious tolerated doses. Subjects who have a history of response to clozapine treatment only.
  6. Subjects with a current Axis I (DSM-IV-TR) diagnosis other than schizophrenia including, but limited:

    • Delirium, dementia, amnesic or other cognitive disorder
    • MDD, 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
  7. Subjects with a current Axis II (DSM-IV-TR) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal or histrionic personality disorder.
  8. Subjects experiencing acute depressive symptoms within the past 30 days, according to the investigator's opinion, that require treatment with an antidepressant.
  9. Subjects who present a serious risk of suicide
  10. BMI> 40 kg/m2 (morbid obesity)at screening
  11. Subjects who previously enrolled in any prior aripiprazole IM depot clinical trial regardless if they received an injection of IMP or not.
  12. Subjects with a history of neuroleptic malignant syndrome
  13. Subjects with a history of true allergic response (ie, not intolerance) to more than 1 class of medications.
  14. Subjects who received any investigational agent in a clinical trial within 3 months prior to screening.
  15. 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.
  16. Any subject who, in the opinion of the investigator, should not participate in the trial.

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): NCT03172871


Contacts
Contact: Amber Zhang 010-81582966 zhangle@obri.otsuka.com
Contact: Yanping Chen 010-81582966 chenyp@obri.otsuka.com

Locations
China, Beijing
Beijing Anding Hospital of Capital Medical University Recruiting
Beijing, Beijing, China, 100088
Contact: Qian Zhao, MD         
Principal Investigator: Gang Wang, MD         
Sponsors and Collaborators
Otsuka Beijing Research Institute
Investigators
Study Director: Patyman Juma Otsuka Beijing Research Institute

Responsible Party: Otsuka Beijing Research Institute
ClinicalTrials.gov Identifier: NCT03172871     History of Changes
Other Study ID Numbers: 031-403-00048
First Posted: June 1, 2017    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Otsuka Beijing Research Institute:
Schizophrenia
Aripiprazole Intramuscular Depot
Acute treatment

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs