ASPIRE OPEN-LABEL
Research type
Research Study
Full title
A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients with Schizophrenia “ASPIRE OPEN-LABEL” (Aripiprazole Intramuscular Depot Program in Schizophrenia)
IRAS ID
20546
Contact name
Gary Sullivan
Sponsor organisation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Eudract number
2008-002699-83
Clinicaltrials.gov Identifier
Research summary
Schizophrenia is a chronic condition that requires continual treatment to maintain adequate cognitive and social functioning. Most medications prescribed form schizophrenia must be taken every day. Some people find this difficult and do not take their medications the way they need to in order to control the schizophrenia. This study is being done to find out the potential benefits and safety of aripiprazole when given as a long-acting intramuscular injection (IM depot) for the maintenance treatment of schizophrenia. Aripiprazole (oral tablets) has been approved by the European medicines Agency and several other regulatory authorities in other countries for the treatment of schizophrenia and other mental disorders. This is an open label study which will enrol adult patients aged 18 to 65 years old (inclusive) who have been diagnosed with schizophrenia. Aripiprazole IM depot will be administered every 4 weeks. Participants will be required to visit their study doctor weekly, fortnightly or every 4 weeks depending on the stage of the study. During these visits, Participants will undergo a number of assessments e.g. physical examination, ECG, measurement of vital signs, collection of blood and urine samples for laboratory analysis, completion of questionnaires and mental health assessments. Participants will also be asked to visit their study doctor 2 weeks and 4 weeks after the last study visit to undergo follow up assessments. Additional follow up will be required if the patient receives at least 1 IM depot injection. The duration of participation will be at least 1.6 years to at most 2 years. The study will be conducted at 250 centres globally and at 3 centres within the UK. Otsuka Pharmaceutical Development & Commercialization, Inc. is the sponsor of this study.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
10/H0408/46
Date of REC Opinion
9 Aug 2010
REC opinion
Further Information Favourable Opinion