Anti-psychotic Medication (New Use) Weight Loss Study

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

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 just started taking (for less than three months) certain anti-psychotic medications (Risperdal, Seroquel, and/or Zyprexa).

Descripción detallada

A total of 30 subjects will be enrolled in this study. They will be randomized in to one of two groups. One group (of 20 subjects) will take 500 mg of the investigational product (IHBG-10) 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. The other group (of 10 subjects) will take a placebo 15 minutes prior to the three main meals of the day; subjects will continue to take their prescribed anti-psychotic medications. Subjects will take the investigational product or placebo for 12 weeks. Participation in this study involves 4 study visits.

Estado general Withdrawn
Fecha de inicio April 2013
Fecha de Terminación December 2013
Fecha de finalización primaria December 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: Dietary Supplement

Nombre de intervención: IHBG-10

Descripción: 500 mg IHBG-10

Etiqueta de grupo de brazo: Study Group

Otro nombre: IHBG10

Tipo de intervención: Dietary Supplement

Nombre de intervención: Placebo

Descripción: Placebo taken 15 minutes prior to the three main meals of the day

Etiqueta de grupo de brazo: Control Group

Otro nombre: sugar pill

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

- 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

Género: All

Edad mínima: 18 Years

Edad máxima: N/A

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Timothy Soundy, 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 2
Grupo de brazo

Etiqueta: Study Group

Tipo: Experimental

Descripción: Subjects will take 500 mg IHBG-10 15 minutes prior to the three main meals of the day.

Etiqueta: Control Group

Tipo: Placebo Comparator

Descripción: Subjects will take a placebo 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