Real Life Assessment of Abilify Maintena

Schizophrenia Clinical Trial

— ReLiAM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02131415
• Other study ID #: 15914N
• Status: Terminated
• Phase: N/A
• First received: April 11, 2014
• Last updated: March 9, 2017
• Start date: May 2014
• Est. completion date: February 15, 2017

Study information

• Verified date: March 2017
• Source: Lundbeck Canada Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 200
• Est. completion date: February 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Related Conditions & MeSH terms

• Schizophrenia

Locations

Country	Name	City	State
Canada	CA011	Brockville	Ontario
Canada	CA012	Calgary	Alberta
Canada	CA001	Chatham	Ontario
Canada	CA006	Halifax	Nova Scotia
Canada	CA014	Kingston	Ontario
Canada	CA004	Kitchener	Ontario
Canada	CA013	London	Ontario
Canada	CA016	Mississauga	Ontario
Canada	CA003	Montreal	Quebec
Canada	CA009	Montreal	Quebec
Canada	CA015	Montreal	Quebec
Canada	CA010	Ottawa	Ontario
Canada	CA008	Penticton	British Columbia
Canada	CA005	Quebec
Canada	CA019	Riviere-du-Loup	Quebec
Canada	CA017	Vancouver	British Columbia
Canada	CA002	Windsor	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lundbeck Canada Inc.	Otsuka Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change in GAF score while on treatment with Abilify Maintena™ for 12 months		from baseline to 12 months
Secondary	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
Secondary	The change in GAF score at various time points over 24 months		from baseline to 3, 6, 9,15, 18, 21, 24 months.
Secondary	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
Secondary	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
Secondary	Number of patients with Adverse Events as a measure of safety and tolerability.		At 3, 6, 9,12,15,18, 21, 24 months
Secondary	The change in SOFAS score while on treatment with Abilify Maintena™.		from baseline to 3, 6 ,9 ,12 ,15 ,18 ,21 ,24 months