Back to resultsMetabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
Primary Purpose
Bipolar Disorders, Metabolic Complication
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
aripiprazole
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorders focused on measuring Bipolar disorder, metabolic complication, Aripiprazole, Weight gain, Clinical Trial, Antipsychotic, Metabolic syndrome, Psychopharmacology, Open Label
Eligibility Criteria
Inclusion Criteria:
- patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
- age between 18 and 65
- Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
- patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)
Exclusion Criteria:
- diagnosis of eating disorder, substance abuse, and psychotic disorder
- history of neurological and medical illness
- pregnant or breast feeding women
Sites / Locations
- Seoul National University Bundang Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
treatment as usual
switch to aripiprazole
Arm Description
patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine
aripiprazole
Outcomes
Primary Outcome Measures
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
Secondary Outcome Measures
ECG prolactin SAS BAS UKU-SERS-Pat-Korean version
Full Information
NCT ID
NCT00845988
First Posted
February 14, 2009
Last Updated
December 4, 2013
Sponsor
Seoul National University Hospital
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00845988
Brief Title
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
Official Title
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders Having Drug-induced Weight Gain
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korea Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary goal of this study is to investigate metabolic changes and maintaining efficacy in stabilized patients with bipolar disorders who have pharmacologically induced weight gain.
Detailed Description
reduced treatment adherence due to metabolic side effects
suggested advantages of aripiprazole in metabolic profile over other antipsychotics or mood stabilizers
randomized trial of switch from previous drugs to aripiprazole
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorders, Metabolic Complication
Keywords
Bipolar disorder, metabolic complication, Aripiprazole, Weight gain, Clinical Trial, Antipsychotic, Metabolic syndrome, Psychopharmacology, Open Label
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment as usual
Arm Type
Active Comparator
Arm Description
patients showing weight gain while receiving treatment with risperidone, olanzapine, quetiapine, or clozapine
Arm Title
switch to aripiprazole
Arm Type
Experimental
Arm Description
aripiprazole
Intervention Type
Drug
Intervention Name(s)
aripiprazole
Intervention Description
dosage form : po recommended dosage : more than 10mg/day duration : 28 weeks
Primary Outcome Measure Information:
Title
Weight BMI Glucose and lipid profiles CGI-BP KOQOL SWN-K
Time Frame
0, 4, 8, 12, 18, 26 week
Secondary Outcome Measure Information:
Title
ECG prolactin SAS BAS UKU-SERS-Pat-Korean version
Time Frame
0, 4, 8, 12, 18, 26 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV criteria
age between 18 and 65
Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI - BP ≤ 3
patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain)
Exclusion Criteria:
diagnosis of eating disorder, substance abuse, and psychotic disorder
history of neurological and medical illness
pregnant or breast feeding women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyooseob Ha, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Metabolic Effects of Switching to Aripiprazole in Patients With Bipolar Disorders
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