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

Patrocinadores

Patrocinador principal: Avera McKennan Hospital & University Health Center

Fuente Avera McKennan Hospital & University Health Center
Resumen breve

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.

Descripción detallada

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.

Estado general Withdrawn
Fecha de inicio March 2012
Fecha de Terminación January 2013
Fecha de finalización primaria January 2013
Fase Phase 2
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Weight 12 weeks
Resultado secundario
Medida Periodo de tiempo
Body composition 12 weeks
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: Placebo

Descripción: Placebo

Etiqueta de grupo de brazo: Control Group

Otro nombre: sugar pill

Tipo de intervención: Dietary Supplement

Nombre de intervención: IHBG-10

Descripción: 500 mg IHBG-10

Otro nombre: IHBG10

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Edward Zawada, MD Principal Investigator Avera McKennan Hospital & University Health Center
Ubicación
Instalaciones: Avera Research Institute
Ubicacion Paises

United States

Fecha de verificación

May 2012

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 4
Grupo de brazo

Etiqueta: Control Group

Tipo: Placebo Comparator

Etiqueta: Risperdal Group

Tipo: Experimental

Descripción: 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.

Etiqueta: Seroquel Group

Tipo: Experimental

Descripción: 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.

Etiqueta: Zyprexa Group

Tipo: Experimental

Descripción: 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.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Fuente: ClinicalTrials.gov