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SchizophreniaPhase 3ATTAIN 266NCT01149655

Efficacy & Safety Study of Oral Aripiprazole in Adolescents With Schizophrenia

A Phase 3 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 52 sites in 7 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

This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period. Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Schizophrenia
What is being tested?
Aripiprazole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
252 participants
Where
52 sitesin 7 countries
Study dates
Jul 2011to Dec 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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Subjects with a current DSM-IV-TR diagnosis of schizophrenia, and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening.
  • Subjects who have shown previous response to antipsychotic treatment (other than clozapine) and are not resistant to treatment with other antipsychotics.
  • Subjects who are currently being treated with oral or depot antipsychotics other than clozapine.
  • Subjects with a history of relapse and/or exacerbation of symptoms when they are not receiving antipsychotic treatment.

Who cannot join

  • Subjects with a current DSM-IV-TR diagnosis other than schizophrenia.
  • Subjects with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (i.e., medication, illicit drug use, etc.).
  • Subjects with attention deficit disorder or attention deficit hyperactivity disorder and/or subjects who were on a stimulant treatment for any period of time over the last one year prior to screening.
  • Subjects with any neurodevelopmental disorder, except Tourette's syndrome.
  • Subjects experiencing acute depressive symptoms within the past 30 days prior to screening.
  • Subjects who meet the DSM-IV-TR criteria for substance dependence (including alcohol and benzodiazepines, but excluding caffeine and nicotine) within the past 180 days prior to screening.
Show all 9Show fewer
  • Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or have a history or current evidence of other unstable medical conditions.
  • Subjects with a history of subclinical hypothyroidism (TSH ≥ 4.0 mIU/L), known hypothyroidism or hyperthyroidism (unless the condition has been stabilized with medication for at least 90 days prior to entry into Phase 1 or Phase 2).
  • Subjects who have a medical history of uncontrolled diabetes, labile or unstable diabetes (brittle diabetes), newly diagnosed diabetes, or clinically significant abnormal blood glucose levels.

Trial locations and contacts

52 sites in 7 countries.

52 sites in 7 countries

Russia16 sites

  • Study Site

    Arkhangelsk, 163530

  • Study Site

    Kazan', 420061

  • Study Site

    Lipetsk, 399313

  • Study Site

    Moscow, 124617

  • Study Site

    Moscow, 127083

  • Study Site

    Nizhny Novgorod, 603155

  • Study Site

    Novosibirsk, 630091

  • Study Site

    Orenburg, 460000

  • Study Site

    Petrozavodsk, 185001

  • Study Site

    Saint Petersburg, 190005

  • Study Site

    Saint Petersburg, 197376

  • Study Site

    Saratov, 410028

  • Study Site

    Tomsk, 634014

  • Study Site

    Tonnelnyi Township, 357034

  • Study Site

    Yaroslavl, 150003

  • Study Site

    Yekaterinburg, 620030

Other trials in Russia

India11 sites

  • Study Site

    Chennai, Tamil Nadu, 600003

  • Study Site

    Chhatrapati Sambhajinagar, Maharashtra, 431005

  • Study Site

    Guntur, 522001

  • Study Site

    Lucknow, Uttar Pradesh, 226003

  • Study Site

    Madurai, Tamil Nadu, 625020

  • Study Site

    Maninagar, Ahmedabad, Gujarat, 380008

  • Study Site

    Raipur, Chhattisgarh, 492001

  • Study Site

    Varanasi, Uttar Pradesh, 221005

  • Study Site

    Vijayawada, Andhra Pradesh, 520002

  • Study Site

    Visakhapatnam, Andhra Pradesh, 530017

  • Study Site

    Wardha, Maharashtra, 442004

Other trials in India

United States8 sites

  • Study Site

    Atlanta, Georgia, 30308

  • Study Site

    Bloomfield Hills, Michigan, 48302

  • Study Site

    Bothell, Washington, 98011

  • Study Site

    Chapel Hill, North Carolina, 27517

  • Study Site

    Downy, California, 90241

  • Study Site

    Glendale, California, 91204

  • Study Site

    Miami, Florida, 33155

  • Study Site

    Miami Springs, Florida, 33166

Other trials in United States

Philippines5 sites

  • Study Site

    Bajada, Davao City, 8000

  • Study Site

    Dasmariñas, Cavite, 4114

  • Study Site

    Iloilo City, 5000

  • Study Site

    Mandaluyong, 1553

  • Study Site

    Manila, National Capital Region, 1000

Other trials in Philippines

Romania5 sites

  • Study Site

    Bucharest, 041914

  • Study Site

    Cluj-Napoca, Cluj, 400084

  • Study Site

    Craiova, Dolj, 200620

  • Study Site

    Iași, 700282

  • Study Site

    Timișoara, Timiș County, 300239

Other trials in Romania

Malaysia4 sites

  • Study Site

    Batu Caves, Selangor, 68100

  • Study Site

    Ipoh, Perak, 30450

  • Study Site

    Johor Bahru, 81200

  • Study Site

    Kuala Lumpur, Kuala Lumpur, 50603

Other trials in Malaysia

Taiwan3 sites

  • Study Site

    Kaohsiung County, 833

  • Study Site

    Taipei, 110

  • Study Site

    Taoyuan County, 333

Other trials in Taiwan

About this study

Official title: A Long-Term Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Aripiprazole (OPC 14597) as Maintenance Treatment in Adolescent Patients With Schizophrenia

This will be a randomized, double-blind, placebo-controlled study consisting of a screening period, a conversion phase (Phase 1), a stabilization phase (Phase 2), and a double-blind maintenance treatment phase (Phase 3), and a follow up period.

Subjects may be either outpatients or inpatients between screening and through the time they reach stabilization at the end of Phase 2; hospitalization is not a study requirement. However, eligible subjects must be outpatients at the beginning of Phase 3.

Read more

Subjects will be assessed weekly during Phase 1, weekly for the first 4 weeks of Phase 2 and 3, and biweekly for the remaining weeks during each of Phases 2 and 3. Subjects will be encouraged to call the investigators with any exacerbation of psychotic symptoms and/or any tolerability issues. The investigator will also have the option to phone the subjects and their guardian(s) at any time to ensure clinical stability.

A data monitoring committee (DMC) will provide oversight for safety monitoring and reviewing the interim analysis. One interim analysis is planned after 75% of the total expected number of impending relapse events (28 events) are achieved and will be conducted by an independent data analysis center. The DMC will make a recommendation about stopping or continuing the study based on safety and efficacy reviews. The results of the interim analysis and individual subject data will remain blinded to the sponsor during the course of the study until the DMC determines that the study will conclude based on the results of the interim analysis, or the study is completed after 37 endpoint events.

Conditions
Schizophrenia
Being tested
Aripiprazole
Keywords
Adolescent, Schizophrenia
Medical subject headings
Schizophrenia

What participants receive

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

  • AripiprazoleDrug

    Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

  • AripiprazoleDrug

    Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)

Study groups in NCT01149655
Study groupRoleWhat they receive
Phase 1ExperimentalAripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Receives: Drug: Aripiprazole
Phase 2ExperimentalAripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
Receives: Drug: Aripiprazole
Phase 3Placebo comparatorAripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg) or placebo
Receives: Drug: Aripiprazole

What is being measured

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

  1. Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse.

    The primary efficacy variable was overall relapse rate from randomization, as assessed by Clinical Global Impression of Improvement (CGI-I) score ≥5, Positive and Negative Syndrome Scale (PANSS) scores for hostility or uncooperativeness ≥5, or ≥20% increase in PANSS Total Score. Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items (conceptual disorganization, hallucinatory behavior, suspiciousness, unusual thought content). OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.

    Measured: Baseline to Week 52/End of Phase 3 visit.

Secondary outcomes (4)

  1. Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.

    Impending relapse was defined as meeting any of the following 5 criteria: 1) CGI-I score of ≥ 5 (minimally worse) and increase in individual PANSS items to a score > 4 with an absolute increase of ≥ 2 on that specific item or absolute increase of ≥ 4 on the combined 4 PANSS items. OR 2) CGI-I score of 6 or 7 (much or very much worse) OR 3) Hospitalization due to worsening of illness OR 4) Any suicidal behavior or answers of "yes" to Questions 4 or 5 on the suicidal ideation section of the C-SSRS OR 5) Violent or aggressive behavior resulting in clinically significant injury.

    Measured: Baseline to Week 52/End of Phase 3 visit.

  2. Percentage of Responders in Each Treatment Group.

    Percentage of responders in each treatment group (i.e, response defined as meeting stability criteria). Participants stabilized on aripiprazole (trial drug) within the approved dose range of 10 to 30 mg/day and are tolerable based on clinical judgment.

    Measured: Baseline to Week 52/End of Phase 3 visit

  3. Percentage of Participants Who Had Achieved Remission.

    Percentage of participants who had achieved remission, where remission was defined as a score of ≤ 3 on each of the following specific PANSS items, maintained for a period of 6 months: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/ posturing, blunted affect, social withdrawal, and lack of spontaneity.

    Measured: Baseline to Week 52/End of Phase 3 visit.

  4. Percentage of Participants Who Discontinued Due to All Reasons Other Than Sponsor Discontinued Study.

    Percentage of participants discontinued due to all reasons other than sponsor discontinued study were noted.

    Measured: Baseline to Week 52/End of Phase 3 visit

Timeline

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

  1. First posted23 Jun 2010 (estimated)
  2. Study startJul 2011
  3. Primary completionNov 2013
  4. Study completionDec 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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
252 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01149655
Sponsor's protocol ID
31-09-266
Acronym
ATTAIN 266
Status last verified
Apr 2015
First submitted
22 Jun 2010
Last updated
2 Apr 2015
Data monitoring committee
Yes

Publications

  • Correll CU, Kohegyi E, Zhao C, Baker RA, McQuade R, Salzman PM, Sanchez R, Nyilas M, Carson W. Oral Aripiprazole as Maintenance Treatment in Adolescent Schizophrenia: Results From a 52-Week, Randomized, Placebo-Controlled Withdrawal Study. J Am Acad Child Adolesc Psychiatry. 2017 Sep;56(9):784-792. doi: 10.1016/j.jaac.2017.06.013. Epub 2017 Jul 8.

    PubMed 28838583

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aripiprazole in people with Schizophrenia, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 52 sites in 7 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 4 inclusion and 9 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 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 52 sites in Russia, India, United States, Philippines, Romania and 2 more countries. 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 2 Apr 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?

Overall Relapse Rate (in Percent) From Randomization to Exacerbation of Psychotic Symptoms/Impending Relapse. (time frame: Baseline to Week 52/End of Phase 3 visit.). 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 NCT01149655, which also lists 1 linked publication.

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 2 Apr 2015.

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