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SchizophreniaPhase 3NCT01663532

Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

A Phase 3 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 49 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia. The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole IM Depot
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
340 participants
Where
49 sitesin 3 countries
Study dates
Oct 2012to Sep 2013
Phase
Phase 3
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 and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
  • 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.
  • Subjects with a stable living environment when not in hospital.
  • Subjects who would benefit from hospitalization or continued hospitalization for treatment of a current acute relapse of schizophrenia at trial entry.
  • Subjects who are experiencing an acute exacerbation of psychotic symptoms and marked deterioration of usual function as demonstrated by meeting BOTH of the following at screening and baseline:
  • Currently experiencing an acute exacerbation of psychotic symptoms accompanied by significant deterioration in the subject's clinical and/or functional status from their baseline clinical presentation with a Positive and Negative Syndrome Scale (PANSS) Total Score ≥ 80 AND
Show all 17Show fewer
  • Specific psychotic symptoms on the PANSS as measured by a score of > 4 on each of the following items (possible scores of 1 to 7 for each item)
  • Conceptual disorganization (P2)
  • Hallucinatory behavior (P3)
  • Suspiciousness/persecution (P6)
  • Unusual thought content (G9)
  • Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration and who showed a previous good response to such antipsychotic treatment (other than clozapine) in last 12 months.
  • Subjects with a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding current episode.
  • Subjects willing to discontinue all prohibited psychotropic medications to meet protocol required washouts prior to and during trial period.
  • BMI less ≤ 40 kg/m2 (morbid obesity) at screening.
  • Subjects who are able to provide written informed consent.
  • Ability to understand the nature of trial and follow protocol requirements.

Who cannot join

  • Sexually active males of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 180 days after last dose of trial medication. Sexually active females of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 150 days after last dose of trial medication.
  • Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP in this trial.
  • Subjects with improvement of ≥ 30% in total PANSS score between the screening and baseline assessments. - Subjects presenting with a first episode of schizophrenia - Subjects hospitalized for ≥ 30 days out of the last 90 days prior to screening visit. Subjects who have been hospitalized > 5 days for current acute episode at the time of screening visit
  • Subjects with schizophrenia who are considered resistant/refractory to antipsychotic treatment Subjects who have a history of response to clozapine treatment only.
  • Subjects with a current DSM-IV-TR Axis I diagnosis other than schizophrenia Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder or mental retardation.
  • Subjects experiencing acute depressive symptoms within past 30 days that require treatment with an antidepressant.
Show all 10Show fewer
  • Subjects with a significant risk of violent behavior; who represent a risk of committing suicide as indicated by any suicidal ideation within the last 1 month or any suicidal behaviors within the last year; or who present a serious risk of suicide.
  • Subjects with clinically significant tardive dyskinesia,.
  • Subjects with severe akathisia.
  • Subjects who have met DSM-IV-TR criteria for substance abuse with past 3 months prior to screening or dependence within past 6 months; including alcohol and benzodiazepines, but excluding caffeine and nicotine.

Trial locations and contacts

49 sites in 3 countries.

49 sites in 3 countries

United States43 sites

  • Study site

    Anaheim, California, 92805

  • Study site

    Atlanta, Georgia, 30308

  • Study site

    Austin, Texas, 78731

  • Study site

    Austin, Texas, 78754

  • Study site

    Bradenton, Florida, 34208

  • Study site

    Carson, California, 90746

  • Study site

    Charleston, South Carolina, 29407

  • Study site

    Dallas, Texas, 75231

  • Study site

    Dallas, Texas, 75243

  • Study site

    Dayton, Ohio, 45417

  • Study site

    Denver, Colorado, 80209

  • Study site

    Escondido, California, 92025

  • Study site

    Flowood, Mississippi, 39232

  • Study site

    Fort Lauderdale, Florida, 33301

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Lauderdale, Florida, 33334

  • Study site

    Hoffman Estates, Illinois, 60169

  • Study site

    Holliswood, New York, 11423

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77007

  • Study site

    Kissimmee, Florida, 34741

  • Study site

    Lake Charles, Louisiana, 70629

  • Study site

    Little Rock, Arkansas, 72201

  • Study site

    Long Beach, California, 90806

  • Study site

    Long Beach, California, 90813

  • Study site

    Marlton, New Jersey, 08053

  • Study site

    National City, California, 91950

  • Study site

    Oakland, California, 94612

  • Study site

    Oceanside, California, 92056

  • Study site

    Orlando, Florida, 32810

  • Study site

    Philadelphia, Pennsylvania, 19139

  • Study site

    Pico Rivera, California, 90660

  • Study site

    Saint Charles, Missouri, 63304

  • Study site

    Salt Lake City, Utah, 84106

  • Study site

    San Diego, California, 92102

  • Study site

    San Diego, California, 92123

  • Study site

    Santa Ana, California, 92701

  • Study site

    Sherman Oaks, California, 91403

  • Study site

    Springdale, Arkansas, 72764

  • Study site

    St Louis, Missouri, 63118

  • Study site

    St Louis, Missouri, 63128

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Washington D.C., District of Columbia, 20016

Other trials in United States

Latvia4 sites

  • Study site

    Daugavpils, LV-5417

  • Study site

    Jelgava, LV-3008

  • Study site

    Liepāja, LV-3401

  • Study site

    Strenči, LV-4730

Other trials in Latvia

Croatia2 sites

  • Study site

    Popovača, 44317

  • Study site

    Zagreb, 10090

Other trials in Croatia

About this study

Official title: A 12-week, Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of Aripiprazole Intramuscular Depot (OPC-14597, Lu AF41155) in the Acute Treatment of Adults With Schizophrenia

The primary purpose of this study is to evaluate the overall efficacy of aripiprazole intramuscular (IM) depot as acute treatment in subjects with schizophrenia.

The secondary purpose is to evaluate the safety and tolerability of aripiprazole IM depot administered every 4 weeks for 12 weeks to adult subjects with schizophrenia.

Conditions
Schizophrenia
Being tested
Aripiprazole IM Depot, Placebo
Keywords
Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Aripiprazole IM DepotDrug

    Also called OPC-14597, Lu AF41155

  • PlaceboDrug

    Matching Placebo

Study groups in NCT01663532
Study groupRoleWhat they receive
Aripiprazole IM DepotExperimentalAripiprazole IM Depot 400 mg, with allowed decrease to 300 mg for safety and return to 400 mg for efficacy if needed, every four weeks for 12 weeks
Receives: Drug: Aripiprazole IM Depot
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score.

    The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 that indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. The PANSS total score was the sum of the rating scores for 7 positive subscale items, 7 negative subscale items, and 16 general psychopathology subscale items from the PANSS panel. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome). The primary statistical comparison was performed using the Mixed Model Repeated Measure (MMRM) approach.

    Measured: Baseline to Week 10

Secondary outcomes (6)

  1. Mean Change From Baseline to Endpoint in Clinical Global Impression-Severity Scale (CGI-S) Score.

    The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 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.

    Measured: Baseline to Week 10

  2. Mean Change From Baseline to Endpoint in PANSS Positive Subscale Score.

    The PANSS consisted of three subscales that contained a total of 30 symptom constructs. For each symptom construct, severity is rated on a 7-point scale, with a score of 1 indicated the absence of symptoms and a score of 7 indicated extremely severe symptoms. In positive subscale, the 7 positive symptom constructs were: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility. PANSS Positive Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).

    Measured: Baseline to Week 10

  3. Mean Change From Baseline to Endpoint in PANSS Negative Subscale Score.

    The PANSS consisted of three subscales: a total of 30 symptom constructs. For each symptom construct, severity was rated on a 7-point scale, with a score of 1 indicated- absence of symptoms and a score of 7 indicated- extremely severe symptoms. The PANSS negative subscale score was the sum of the rating scores for the 7 negative scale items from the PANSS panel. The 7 negative symptom constructs were: blunted affect, emotional withdrawal, poor rapport, passive apathetic withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation and stereotyped thinking. PANSS Negative Subscale Score ranges from 7 (absence of symptoms) to 49 (extremely severe symptoms).

    Measured: Baseline to Week 10

  4. Mean Change From Baseline to Endpoint in Personal and Social Performance Scale (PSP) Score.

    The PSP was a validated clinician scale that measured personal and social functionining in 4 domains: socially useful activities eg, work and study), personal and social relationships, self-care, disturbing and aggressive behaviours. Impairement in each of these domains was rated as absent, mild, manifest, marked, severe, or very severe. These ratings were then converted to a total score based on a 100-point scale using algorithms to identify the appropriate 10-point interval and the study physician's judgement to determine the total score within the 10-point interval. Participants with a PSP total score of 71 to 100 were considered to have mild functional difficulty. Scores of 31 to 70 represented varying degrees of disability (31 to 70) and ratings of 1 to 30 indicated minimal functioning that required intense support and/or supervision.

    Measured: Week 10

  5. Mean Clinical Global Impression-Improvement Scale (CGI-I) Score at Endpoint.

    The severity of illness for each participants were rated using the CGI-S scale. The study physician were to answer the following question: "Considering your total experience with this particular population, how mentally ill is the patient at this time?" Response choices included were: 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.

    Measured: Week 10

  6. Responder Rate Based on PANSS Total Score.

    Responder rate was defined as ≥30% reduction from Baseline in PANSS Total Score. PANSS Total Score ranged from 30 (best possible outcome) to 210 (worst possible outcome).

    Measured: Week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Aug 2012 (estimated)
  2. Study startOct 2012
  3. Primary completionAug 2013
  4. Study completionSep 2013

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
340 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01663532
Sponsor's protocol ID
31-12-291
Status last verified
Feb 2015
First submitted
9 Aug 2012
Last updated
16 Feb 2015
Data monitoring committee
No

Publications

  • Citrome L, Bell Lynum KS, Zhang Z, Atkins N Jr, Hutson Walker AM, Yildirim M. Aripiprazole Once-Monthly for Patients Diagnosed With Schizophrenia: Number Needed to Treat, Number Needed to Harm, and Likelihood to be Helped or Harmed. J Clin Psychiatry. 2026 May 13;87(2):26m16359. doi: 10.4088/JCP.26m16359.

    PubMed 42138587

  • Kane JM, Peters-Strickland T, Baker RA, Hertel P, Eramo A, Jin N, Perry PP, Gara M, McQuade RD, Carson WH, Sanchez R. Aripiprazole once-monthly in the acute treatment of schizophrenia: findings from a 12-week, randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2014 Nov;75(11):1254-60. doi: 10.4088/JCP.14m09168.

    PubMed 25188501

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole IM Depot in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 49 sites in 3 countries.

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 17 inclusion and 10 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 16 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Latvia, Croatia. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 16 Feb 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?

Mean Change From Baseline to Endpoint in Positive and Negative Syndrome Scale (PANSS) Total Score. (time frame: Baseline to Week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01663532, which also lists 2 linked publications.

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 16 Feb 2015.

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