Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetes Schizoaffective Disorder Schizophrenia Weight Gain

Keywords

SchizophreniaSchizoaffectiveOlanzapineZyprexaClozapineClozarilPramlintideDiabetesWeight GainObesityMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine
Mean Number of Pounds Lost on Pramlintide Over 16 Weeks
16 weeks

Study Arms (2)

Placebo

OTHER

Patients will be given the Placebo for injection twice daily

Drug: Placebo

Pramlintide

OTHER

volunteers are given 180mg of pramlintide, twice daily

Drug: Pramlintide

Interventions

PramlintideDrug

180mg subcutaneous injections, twice daily

Also known as: Amylin

Pramlintide

PlaceboDrug

180mg subcutaneous injections, twice daily

Also known as: sterile saline

Eligibility Criteria

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Volunteers will be males or females 18-65 yrs of age with a diagnosis of schizophrenia or schizoaffective disorder who have a history of significant weight gain with olanzapine or clozapine administration.
Volunteers will have a current BMI=\>27 but equal to or less than 40.

Sponsors & Collaborators

Amylin Pharmaceuticals, LLC.
Industrycollaborator
University of Texas Southwestern Medical Center
Otherlead

Study Sites (1)

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

MeSH Terms

Conditions

SchizophreniaPsychotic DisordersDiabetes MellitusWeight GainObesityMetabolic Syndrome

Interventions

pramlintideIslet Amyloid Polypeptide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title: Carol A. Tamminga, MD
Organization: University of Texas Southwestern Medical Center

Study Officials

Carol A Tamminga, MD
University of Texas Southwestern Medical Center
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

33 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Principal Investigator

Study Record Dates

First Submitted

January 27, 2008

First Posted

June 4, 2008

Study Start

November 2007

Date type not reported

This date has not been verified as actual or estimated.

Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Placebo

Pramlintide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Placebo

Pramlintide

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations