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Real Life Assessment of Abilify Maintena (ReLiAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Lundbeck Canada Inc.

Tracking Information
First Submitted Date April 11, 2014
First Posted Date May 6, 2014
Last Update Posted Date March 10, 2017
Study Start Date May 2014
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 5, 2014)
The change in GAF score while on treatment with Abilify Maintena™ for 12 months [ Time Frame: from baseline to 12 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 5, 2014)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Real Life Assessment of Abilify Maintena
Official Title Canadian Non-Interventional Prospective Cohort Study on the Real - Life Assessment of Abilify Maintena ™ in Schizophrenia
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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients treated with Abilify Maintena™ for schizophrenia
Condition Schizophrenia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: November 21, 2016)
200
Original Estimated Enrollment
 (submitted: May 5, 2014)
252
Actual Study Completion Date February 15, 2017
Actual Primary Completion Date February 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT02131415
Other Study ID Numbers 15914N
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lundbeck Canada Inc.
Study Sponsor Lundbeck Canada Inc.
Collaborators Otsuka Pharmaceutical Co., Ltd.
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
PRS Account Lundbeck Canada Inc.
Verification Date March 2017