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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01272765

Enrollment

Registered

2011-01-10

Start date

2012-03-31

Completion date

2013-01-31

Last updated

2012-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

obesity, weight loss, weight management, anti-psychotic medication, Zyprexa, Seroquel, Risperdal

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.

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.

Interventions

OTHERPlacebo

Placebo

DIETARY_SUPPLEMENTIHBG-10

500 mg IHBG-10

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Weight	12 weeks

Secondary

Measure	Time frame
Body composition	12 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026