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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
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
Lundbeck Canada Inc.

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.

Condition or disease
Schizophrenia

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.

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Study Type : Observational
Actual Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia




Primary Outcome Measures :
  1. The change in GAF score while on treatment with Abilify Maintena™ for 12 months [ Time Frame: from baseline to 12 months ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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. ]
  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. [ Time Frame: 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 [ Time Frame: at 3, 6, 9,12,15,18, 21, 24 months ]
  5. 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 ]
  6. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients treated with Abilify Maintena™ for schizophrenia
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

Information from the National Library of Medicine

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


Locations
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Canada, Alberta
CA012
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
CA008
Penticton, British Columbia, Canada, V2A 4M4
CA017
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Nova Scotia
CA006
Halifax, Nova Scotia, Canada, B3H 2E2
Canada, Ontario
CA011
Brockville, Ontario, Canada, K6V 5W7
CA001
Chatham, Ontario, Canada, N7L 1C1
CA014
Kingston, Ontario, Canada, K7L 4X3
CA004
Kitchener, Ontario, Canada, N2H 4A2
CA013
London, Ontario, Canada, N6A 5W9
CA016
Mississauga, Ontario, Canada, L5M 4N4
CA010
Ottawa, Ontario, Canada, K1H 8L6
CA002
Windsor, Ontario, Canada, N9C 3Z4
Canada, Quebec
CA009
Montreal, Quebec, Canada, H1N 3M5
CA003
Montreal, Quebec, Canada, H3A 1A1
CA015
Montreal, Quebec, Canada, H4H 1R3
CA019
Riviere-du-Loup, Quebec, Canada, G5R 2A4
Canada
CA005
Quebec, Canada, G1J 2G3
Sponsors and Collaborators
Lundbeck Canada Inc.
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Lundbeck Canada Inc.
ClinicalTrials.gov Identifier: NCT02131415     History of Changes
Other Study ID Numbers: 15914N
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Lundbeck Canada Inc.:
schizophrenia
real-life
long-acting injectable
Reliam
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Aripiprazole
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists