Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

What Was Tested

The trial (phase 4) is built around Amylin (Islet Amyloid Polypeptide).

Primary Objective: To test the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain in persons with schizophrenia who are currently taking either drug; measures of the metabolic syndrome will be evaluated as well.

It had two arms (groups): Placebo (other) and Pramlintide (other).

Patients will be given the Placebo for injection twice daily.

The registry classes the interventions as drug.

More on the Plan

This study is a sixteen week placebo-controlled, double-blind investigation of the effect of pramlintide on body weight in clozapine- and olanzapine-induced weight gain.

The researchers will recruit approximately 72 volunteers with the plan of having a final N = 25 in each of the 2 treatment groups.

(This number is to allow for normal attrition in this patient population.

If needed, the researchers will recruit more than 72 volunteers in order to achieve the appropriate number of completed subjects.) Patients will be recruited from the local Dallas public and VA mental health systems as volunteers for this study.

Who Took Part

The registry lists 33 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Volunteers will have a current BMI=\>27 but equal to or less than 40. Volunteers will be willing and able to participate in the subcutaneous administration training week prior to study start. Able and willing to give informed consent.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: any patient with current diabetes mellitus, even if caused by antipsychotic use ; pregnant women or women who are breast feeding; patients concomitantly treated with another conventional or second generation antipsychotic medication or with any other anti-obesity drug.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

Random assignment meant chance, not the researchers, decided who got Amylin (Islet Amyloid Polypeptide) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Amylin (Islet Amyloid Polypeptide).

Those kept unaware of assignments: participant and investigator.

It started in 2007-11 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine (time frame: 16 weeks).

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Amylin (Islet Amyloid Polypeptide) in 33 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Amylin (Islet Amyloid Polypeptide) compound page, all human trials.