A Phase 4 interventional study of aripiprazole and Placebo in Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc.. Completed at 57 sites in 12 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-11-08.
Sponsored by Otsuka Pharmaceutical Development & Commercialization, Inc. · Phase 4, Interventional, and Treatment
The purpose of this study is to evaluate the effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine monotherapy, in schizophrenic patients who are not optimally controlled on clozapine.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 200 is above the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Otsuka Pharmaceutical Development & Commercialization, Inc. is the lead sponsor of 289 studies on the registry; 18 are open to participants now.
Of its 104 completed or terminated interventional studies of FDA-regulated products, 69 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: aripiprazole
Drug: Placebo
Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
Also known as: Abilify
Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
Evaluate effect on patient weight of adjunctive therapy of aripiprazole with clozapine versus clozapine mono-therapy in schizophrenic patients who are not optimally controlled on clozapine.
The mean change from baseline in patient weight at Week 16 (LOCF) will be compared between the 2 groups.
Efficacy (PANSS, CGI)
Effectiveness (IAQ, GAF)
Patient Reported Outcomes
Safety
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Otsuka Pharmaceutical Development & Commercialization, Inc.