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SchizophreniaReLiAMNCT02131415

Real Life Assessment of Abilify Maintena

An observational study of Schizophrenia, run by Lundbeck Canada Inc. at 17 sites in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a non-interventional, Canadian, study in patients treated with Abilify Maintena™ for schizophrenia followed for 24 months, with 9 visits recommended. Study assessments and administration of questionnaires will take place during the patient regular assessments or injection visits that are part of routine care. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
How many people
200 participants
Where
17 sitesCanada
Study dates
May 2014to 15 Feb 2017
Phase
Observational
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: patients treated with Abilify Maintena™ for schizophrenia

Who may be able to join

  • The patient must be 18 (19 for patients from British Columbia) years of age or older.
  • The patient must have been diagnosed with schizophrenia.
  • The patient must be at least mildly ill (CGI-S score of ≥3).
  • The treating physician must have reached the decision to treat the patient with Abilify Maintena™ prior to and independently of soliciting the patient to participate in the study.
  • The patient and legal guardian (if applicable and when allowable by law) must have signed an informed consent indicating the understanding of the study and allowing the use of their anonymous data for the purposes of the study.
  • The patient and caregiver(s) (if applicable) must be fluent in English or French, in order to be able to complete the questionnaires.

Who cannot join

  • The patient does not comprehend or refuses to sign the informed consent.
  • The patient has any contraindications to the use of Abilify Maintena™ as specified in the Canadian Product Monograph.
  • The patient has previously received one or more doses of Abilify Maintena™.
  • The patient presents a significant suicidal risk as judged by the investigator.
  • The patient is a pregnant or lactating female.
  • The patient is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
  • The patient has previously been enrolled in this study.
  • The patient is, in the investigator's opinion, unlikely to comply with the protocol

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Canada17 sites

  • CA011

    Brockville, Ontario, K6V 5W7

  • CA012

    Calgary, Alberta, T2N 4Z6

  • CA001

    Chatham, Ontario, N7L 1C1

  • CA006

    Halifax, Nova Scotia, B3H 2E2

  • CA014

    Kingston, Ontario, K7L 4X3

  • CA004

    Kitchener, Ontario, N2H 4A2

  • CA013

    London, Ontario, N6A 5W9

  • CA016

    Mississauga, Ontario, L5M 4N4

  • CA009

    Montreal, Quebec, H1N 3M5

  • CA003

    Montreal, Quebec, H3A 1A1

  • CA015

    Montreal, Quebec, H4H 1R3

  • CA010

    Ottawa, Ontario, K1H 8L6

  • CA008

    Penticton, British Columbia, V2A 4M4

  • CA005

    Québec, Quebec, G1J 2G3

  • CA019

    Rivière-du-Loup, Quebec, G5R 2A4

  • CA017

    Vancouver, British Columbia, V5Z 1M9

  • CA002

    Windsor, Ontario, N9C 3Z4

Other trials in Canada

About this study

Official title: Canadian Non-Interventional Prospective Cohort Study on the Real - Life Assessment of Abilify Maintena ™ in Schizophrenia

This is a non-interventional, Canadian, study in patients treated with Abilify Maintena™ for schizophrenia followed for 24 months, with 9 visits recommended. Study assessments and administration of questionnaires will take place during the patient regular assessments or injection visits that are part of routine care. The main objective of the study is to describe the impact of treatment with Abilify Maintena™ on global functional status.

Read the detailed description
  • Treatment
  • All patients will be treated with Abilify Maintena™ administered once monthly at the dose that is as per the treating physician's judgment.
  • The assignment of the patients to be treated with Abilify Maintena™ is not decided in advance by the study protocol and is clearly separated from the decision to include the patients in the study. For all patients that will be included in the study, the decision to initiate treatment with Abilify Maintena™ must have been reached prior to and independently of enrolling the patient in the study.
  • Any treatment is to be prescribed according to the recommendations given in the approved Canadian Product Monograph.
  • Study Sites
  • Up to 30 sites planned in Canada: Patients will be recruited by community or hospital based psychiatrists. A random representative sample of Canadian psychiatrists will be identified as the sampled population of physicians that will be invited to participate in the study and will undergo a feasibility assessment. Those that satisfy the feasibility assessment, have adequate volume of patients and are willing to participate in the study will be enrolled.
  • Data Collection and Handling
  • All patient data will be collected by the site investigator or designated staff and will be entered in an electronic data capture (EDC) system that will be developed for the study. Patient questionnaires will be completed during the visit using paper-based surveys. The questionnaire data will be transcribed into the study database by the CRO personnel using a double data entry system. There will be no patient identifying information recorded in any of the study data collection forms or databases. All patients will be identified using encrypted random study ID numbers. Data monitoring and source verification will be conducted on a sample of patients. Auditing of patient qualification will also be conducted on a sample of patients within each site.
  • Missing data handling
  • There will be no imputation for missing data. General linear models with repeated measures and mixed effects will be used to compensate for unequal follow up intervals and missing data points. All analyses will be conducted on observed cases.
  • Safety analyses - The safety population will comprise all patients included in the study that have had at least one treatment with Abilify Maintena™. Adverse events will be described with the MedDRA dictionary of terms classified by preferred term and system - organ class.
Conditions
Schizophrenia
Keywords
schizophrenia, real-life, long-acting injectable, Reliam
Medical subject headings
Schizophrenia

What is being measured

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

  1. The change in GAF score while on treatment with Abilify Maintena™ for 12 months

    Measured: from baseline to 12 months

Secondary outcomes (6)

  1. The change in score on CGI-I and CGI-S at various timepoints over 24 months.

    Measured: from baseline to 3, 6, 9, 12,15,18, 21,24 months

  2. The change in GAF score at various time points over 24 months

    Measured: from baseline to 3, 6, 9,15, 18, 21, 24 months.

  3. Number of patients achieving remission, amount of time it takes to achieve remission, amount of time they remain in remission and the rates of relapse.

    Measured: from baseline to 3, 6, 9,12,15,18, 21, 24 months

  4. Number of injections of Abilify Maintena™ received over the course of 24 months, in order to describe adherence

    Measured: at 3, 6, 9,12,15,18, 21, 24 months

  5. Number of patients with Adverse Events as a measure of safety and tolerability.

    Measured: At 3, 6, 9,12,15,18, 21, 24 months

  6. The change in SOFAS score while on treatment with Abilify Maintena™.

    Measured: from baseline to 3, 6 ,9 ,12 ,15 ,18 ,21 ,24 months

Timeline

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

  1. First posted6 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completion15 Feb 2017
  4. Study completion15 Feb 2017

Why it stopped: Slow enrollment combined with positive preliminary results

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02131415
Sponsor's protocol ID
15914N
Acronym
ReLiAM
Status last verified
Mar 2017
First submitted
11 Apr 2014
Last updated
10 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Roy MA, Therrien F, Boucher M, Oluboka O. Long-term effectiveness of aripiprazole once monthly on functioning and quality of life in schizophrenia: results of year 2 of the ReLiAM study. BMC Psychiatry. 2024 Nov 14;24(1):797. doi: 10.1186/s12888-024-06240-x.

    PubMed 39538234

  • Oluboka O, Clerzius G, Janetzky W, Schottle D, Therrien F, Wiedemann K, Roy MA. Improvement of functioning in patients with schizophrenia: real-world effectiveness of aripiprazole once-monthly (REACT study). BMC Psychiatry. 2023 May 31;23(1):383. doi: 10.1186/s12888-023-04893-8.

    PubMed 37259053

  • Schottle D, Janetzky W, Therrien F, Wiedemann K. BPRS domains, items and subgroups analyses, and CGI-I ratings in pooled data from non-interventional studies of aripiprazole once-monthly in schizophrenia (REACT study). BMC Psychiatry. 2023 Mar 14;23(1):162. doi: 10.1186/s12888-023-04651-w.

    PubMed 36918846

  • Margolese HC, Boucher M, Therrien F, Clerzius G. Treatment with aripiprazole once-monthly injectable formulation is effective in improving symptoms and global functioning in schizophrenia with and without comorbid substance use - a post hoc analysis of the ReLiAM study. BMC Psychiatry. 2022 Dec 8;22(1):773. doi: 10.1186/s12888-022-04397-x.

    PubMed 36482352

  • Schottle D, Clerzius G, Janetzky W, Oluboka O, Roy MA, Therrien F, Wiedemann K. Real-world effectiveness of aripiprazole once-monthly REACT study: Pooled analysis of two noninterventional studies. Eur Psychiatry. 2022 Jul 20;65(1):e42. doi: 10.1192/j.eurpsy.2022.27.

    PubMed 35855645

  • Mustafa S, Bougie J, Miguelez M, Clerzius G, Rampakakis E, Proulx J, Malla A. Real-life assessment of aripiprazole monthly (Abilify Maintena) in schizophrenia: a Canadian naturalistic non-interventional prospective cohort study. BMC Psychiatry. 2019 Apr 16;19(1):114. doi: 10.1186/s12888-019-2103-x.

    PubMed 30991969

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by Lundbeck Canada Inc. at 17 sites in Canada.

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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Slow enrollment combined with positive preliminary results). Results are not available in the source record.

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?

The change in GAF score while on treatment with Abilify Maintena™ for 12 months (time frame: from baseline to 12 months). 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 NCT02131415, which also lists 6 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 10 Mar 2017.

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