Real Life Assessment of Abilify Maintena

NCT02131415 | Terminated

• 1 other identifier: 15914N
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 17

Brief 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. The main objective of the study is to describe the impact of treatment with Abilify Maintena™ on global functional status.

Conditions

Schizophrenia

Keywords

schizophrenia; real-life; long-acting injectable; Reliam

Outcome Measures

Primary Outcomes (1)

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

  from baseline to 12 months

Secondary Outcomes (6)

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

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

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

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

• 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.

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

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

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

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated with Abilify Maintena™ for schizophrenia

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Lundbeck Canada Inc.: lead
• Otsuka Pharmaceutical Co., Ltd.: collaborator

Study Sites (17)

CA012

Calgary, Alberta, T2N 4Z6, Canada

Location

CA008

Penticton, British Columbia, V2A 4M4, Canada

Location

CA017

Vancouver, British Columbia, V5Z 1M9, Canada

Location

CA006

Halifax, Nova Scotia, B3H 2E2, Canada

Location

CA011

Brockville, Ontario, K6V 5W7, Canada

Location

CA001

Chatham, Ontario, N7L 1C1, Canada

Location

CA014

Kingston, Ontario, K7L 4X3, Canada

Location

CA004

Kitchener, Ontario, N2H 4A2, Canada

Location

CA013

London, Ontario, N6A 5W9, Canada

Location

CA016

Mississauga, Ontario, L5M 4N4, Canada

Location

CA010

Ottawa, Ontario, K1H 8L6, Canada

Location

CA002

Windsor, Ontario, N9C 3Z4, Canada

Location

CA009

Montreal, Quebec, H1N 3M5, Canada

Location

CA003

Montreal, Quebec, H3A 1A1, Canada

Location

CA015

Montreal, Quebec, H4H 1R3, Canada

Location

CA005

Québec, Quebec, G1J 2G3, Canada

Location

CA019

Rivière-du-Loup, Quebec, G5R 2A4, Canada

Location

Related Publications (6)

• 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.

  PMID: 39538234 DERIVED

• 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.

  PMID: 37259053 DERIVED

• 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.

  PMID: 36918846 DERIVED

• 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.

  PMID: 36482352 DERIVED

• 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.

  PMID: 35855645 DERIVED

• 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.

  PMID: 30991969 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Email contact via H. Lundbeck A/S

  LundbeckClinicalTrials@lundbeck.com

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: May 6, 2014
• Study Start: May 1, 2014
• Primary Completion: February 15, 2017
• Study Completion: February 15, 2017
• Last Updated: March 10, 2017

Record last verified: 2017-03

Locations

CA (17)