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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01272752 |
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Date of registration:
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06/01/2011 |
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Primary sponsor: |
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Public title:
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Anti-psychotic Medication (New Use) Weight Loss Study
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Scientific title:
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Surveillance Study of Weight Response and Body Composition in Subjects Who Are First-Time Users (Less Than 3 Months) of the Following Medications: Risperdal, Seroquel, and/or Zyprexa, in Combination With 500 mg IHBG-10 TID |
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Date of first enrolment:
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April 2013 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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http://clinicaltrials.gov/show/NCT01272752 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Timothy Soundy, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Avera McKennan Hospital & University Health Center |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men and women, age 18 and older
- Agree to keep diet, exercise and all current health habits stable during
participation in the study
- Have been taking Risperdal (Risperidone), Seroquel (Quetiapine), or Zyprexa
(Olanzapine) for less than 3 months
Exclusion Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obesity
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Intervention(s)
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Dietary Supplement: IHBG-10
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Dietary Supplement: Placebo
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Primary Outcome(s)
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Weight
[Time Frame: 12 weeks]
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Secondary Outcome(s)
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Body composition
[Time Frame: 12 weeks]
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Secondary ID(s)
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ARI-1310-IHBG10
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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