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Anti-psychotic Medication (Stable Dose) Weight Loss Study
Surveillance Study of Weight Response and Body Composition in Subjects Taking a Stable Dose of Risperdal, Seroquel, and/or Zyprexa for Greater Than 3 Months in Combination With 500 mg IHBG-10 TID
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a pilot study to determine the safety and efficacy of an investigational product (IHBG-10) on weight change and changes in body composition in subjects who have been taking a stable dose of certain anti-psychotic medications for longer than three months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2012
Shorter than P25 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 6, 2011
CompletedFirst Posted
Study publicly available on registry
January 10, 2011
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedJune 1, 2012
May 1, 2012
10 months
January 6, 2011
May 31, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Weight
12 weeks
Secondary Outcomes (1)
Body composition
12 weeks
Study Arms (4)
Control Group
PLACEBO COMPARATORRisperdal Group
EXPERIMENTALSubjects who are on a stable dose of Ripserdal and taking 500 mg IHBG-10 15 minutes prior to the three main meals of the day.
Seroquel Group
EXPERIMENTALSubjects who are on a stable dose of Seroquel and taking 500 mg of IHBG-10 15 minutes before the three main meals of the day.
Zyprexa Group
EXPERIMENTALSubjects who are on a stable dose of Zyprexa and taking 500 mg of IHBG-10 15 minutes prior to the three main meals of the day.
Interventions
Eligibility Criteria
You may qualify if:
- Men and women, age 18 and older
- Agree to keep diet, exercise and all current health habits stable during participation in the study
- Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three months
You may not qualify if:
- Current active acute psychotic episode
- Women who are pregnant, breastfeeding, or planning to become pregnant
- Prior bariatric surgery
- Use of prescription or over-the-counter appetite suppressants, herbal products or other medications for weight loss within the past month
- Obesity as a result of a clinically-diagnosed endocrine problem
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edward Zawada, MD
Avera McKennan Hospital & University Health Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2011
First Posted
January 10, 2011
Study Start
March 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2013
Last Updated
June 1, 2012
Record last verified: 2012-05