Real Life Assessment of Abilify Maintena (ReLiAM)
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|ClinicalTrials.gov Identifier: NCT02131415|
Recruitment Status : Terminated (Slow enrollment combined with positive preliminary results)
First Posted : May 6, 2014
Last Update Posted : March 10, 2017
|Condition or disease|
- 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.
- 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.
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Canadian Non-Interventional Prospective Cohort Study on the Real - Life Assessment of Abilify Maintena ™ in Schizophrenia|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||February 15, 2017|
|Actual Study Completion Date :||February 15, 2017|
- The change in GAF score while on treatment with Abilify Maintena™ for 12 months [ Time Frame: from baseline to 12 months ]
- The change in score on CGI-I and CGI-S at various timepoints over 24 months. [ Time Frame: from baseline to 3, 6, 9, 12,15,18, 21,24 months ]
- The change in GAF score at various time points over 24 months [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: at 3, 6, 9,12,15,18, 21, 24 months ]
- Number of patients with Adverse Events as a measure of safety and tolerability. [ Time Frame: At 3, 6, 9,12,15,18, 21, 24 months ]
- The change in SOFAS score while on treatment with Abilify Maintena™. [ Time Frame: from baseline to 3, 6 ,9 ,12 ,15 ,18 ,21 ,24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02131415
|Study Director:||Email contact via H. Lundbeck A/S||LundbeckClinicalTrials@lundbeck.com|