Anti-psychotic Medication (Stable Dose) Weight Loss Study

This study has been withdrawn prior to enrollment.
(Study did not get started.)
Sponsor:
Information provided by (Responsible Party):
Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier:
NCT01272765
First received: January 6, 2011
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Other: Placebo
Dietary Supplement: IHBG-10
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Avera McKennan Hospital & University Health Center:

Primary Outcome Measures:
  • Weight [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Body composition [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group Other: Placebo
Placebo
Other Names:
  • placebo
  • sugar pill
Experimental: Risperdal Group
Subjects 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.
Dietary Supplement: IHBG-10
500 mg IHBG-10
Other Name: IHBG10
Experimental: Seroquel Group
Subjects 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.
Dietary Supplement: IHBG-10
500 mg IHBG-10
Other Name: IHBG10
Experimental: Zyprexa Group
Subjects 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.
Dietary Supplement: IHBG-10
500 mg IHBG-10
Other Name: IHBG10

Detailed Description:

A total of 80 subjects will be enrolled in this study: 20 subjects will be randomized to receive placebo, and 60 will be randomized to receive the investigational product (20 who are on a stable dose of Seroquel, 20 who are on a stable dose of Risperdal, and 20 who are on a stable dose of Zyprexa). The investigational product or placebo will be taken 15 minutes prior to the three main meals of the day. Subjects will continue to take their prescribed anti-psychotic medications. Participation in this study involves four study visits.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  • Currently on a stable dose of Risperdal (Risperidone), Seroquel (Quetiapine) and/or Zyprexa (Olanzapine) for at least three 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01272765

Locations
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Avera McKennan Hospital & University Health Center
Investigators
Principal Investigator: Edward Zawada, MD Avera McKennan Hospital & University Health Center
  More Information

No publications provided

Responsible Party: Avera McKennan Hospital & University Health Center
ClinicalTrials.gov Identifier: NCT01272765     History of Changes
Other Study ID Numbers: ARI-1320-IHBG10
Study First Received: January 6, 2011
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Avera McKennan Hospital & University Health Center:
obesity
weight loss
weight management
anti-psychotic medication
Zyprexa
Seroquel
Risperdal

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Antipsychotic Agents
Risperidone
Quetiapine
Olanzapine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Antagonists
Dopamine Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on April 17, 2014