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A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00300846
First Posted: March 10, 2006
Last Update Posted: November 8, 2013
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.
Collaborator:
Otsuka America Pharmaceutical
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
March 8, 2006
March 10, 2006
November 8, 2013
December 2005
July 2007   (Final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT00300846 on ClinicalTrials.gov Archive Site
  • Efficacy (PANSS, CGI)
  • Effectiveness (IAQ, GAF)
  • Patient Reported Outcomes
  • Safety
Same as current
Not Provided
Not Provided
 
A Study of Adjunctive Treatment of Aripiprazole in Schizophrenic Patients
A Multicenter, Comparative, Randomized, Double-Blind, Placebo Controlled Study on the Effect on Weight of Adjunctive Treatment With Aripiprazole in Patients With Schizophrenia.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: aripiprazole
    Tablets, Oral, 5 mg, 10 mg, 15 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional).
    Other Name: Abilify
  • Drug: Placebo
    Tablets, Oral, 0 mg, once daily, 16 weeks followed by 12 weeks of Open-Label extension phase (optional)
  • Active Comparator: A1
    Intervention: Drug: aripiprazole
  • Placebo Comparator: A2
    Intervention: Drug: Placebo
Fleischhacker WW, Heikkinen ME, Olié JP, Landsberg W, Dewaele P, McQuade RD, Loze JY, Hennicken D, Kerselaers W. Effects of adjunctive treatment with aripiprazole on body weight and clinical efficacy in schizophrenia patients treated with clozapine: a randomized, double-blind, placebo-controlled trial. Int J Neuropsychopharmacol. 2010 Sep;13(8):1115-25. doi: 10.1017/S1461145710000490. Epub 2010 May 12.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
July 2007
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with schizophrenia treated with clozapine (200-900 mg/day), who gained at least 2.5 kg while on clozapine.

Exclusion Criteria:

  • Patients known to be allergic to aripiprazole
  • Hospitalized patients
  • Patients who have previously received study medication in an aripiprazole clinical study or who have participated in any clinical trial with an investigational agent within the past month.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Austria,   Czech Republic,   Finland,   France,   Germany,   Hungary,   Poland,   South Africa,   Sweden,   Switzerland,   Turkey,   United Kingdom
Belgium,   Netherlands,   Spain
 
NCT00300846
CN138-170
Not Provided
Not Provided
Not Provided
Not Provided
Otsuka Pharmaceutical Development & Commercialization, Inc.
Otsuka America Pharmaceutical
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Otsuka Pharmaceutical Development & Commercialization, Inc.
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP