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Trial · Interventional

CompletedPhase 4Results postedRegistry data

Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

NCTNCT00690235 (opens ClinicalTrials.gov in a new tab)Other id092007-025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
33 participants (actual)
Sponsor
University of Texas Southwestern Medical Center · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
Nov 2007
Primary completion
Aug 2011
Completion
Aug 2011
First posted
4 Jun 2008 (estimated)
Last update posted
16 Nov 2018
Conditions
Schizophrenia · Schizoaffective Disorder · Diabetes · Weight Gain

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
200720082009201020112012
  1. Ph 4

    Demonstrate the Effects of Pramlintide on Weight Reduction in Schizophrenia

    NCT00690235

    Nov 2007 to Aug 2011

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • PramlintideDrug
  • PlaceboDrug

Arms2

  • Other

    Placebo

    Patients will be given the Placebo for injection twice daily

  • Other

    Pramlintide

    volunteers are given 180mg of pramlintide, twice daily

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine

    Time frame · 16 weeks

    Registry description

    Mean Number of Pounds Lost on Pramlintide Over 16 Weeks

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 16 weeks

Weight Loss With Pramlintide in Persons With Schizophrenia Who Have Gained Weight Taking Olanzapine or Clozapine

GroupValue (pounds)Spread
Pramlintide37143.06
Placebo40.5109.26

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Pramlintidevolunteers are given 180mg of pramlintide, twice daily Pramlintide: 180mg subcutaneous injections, twice daily–0 / 122 / 12
PlaceboPatients will be given the Placebo for injection twice daily Placebo: 180mg subcutaneous injections, twice daily–0 / 121 / 12

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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. * Volunteers will have been taking a stable dose (less than 10% dose change) of clozapine or olanzapine or at least two months prior to study start. * 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. Exclusion Criteria: * Clinically significant abnormal pre-admission vital signs, positive HIV, or clinical laboratory evaluations, in which the principal investigator deems the subject-volunteer ineligible for the study * Positive results for infectious diseases and sexually-transmitted diseases will be reported according to the Texas Department of State Health and Texas Administrative Code rules and guidelines * Any patient with current diabetes mellitus, even if caused by antipsychotic use . * Patients with active liver disease requiring current treatment. Positive hepatitis C volunteers will only be excluded if they have active liver disease or they have enzyme values are two times the upper limit of normal. * Any patients with medical disorders that are not properly controlled by medications. * 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. * Mental capacity is limited to the extent that the patient cannot understand the nature of the study along with its risks and benefits. * Subjects with a high risk of suicide since there is a potential that the study medication will lower the subject's glucose levels. * Any patient judged by the principal investigator to be inappropriate for the study. * Known hypersensitivity to study medication or its components * Non-English speaking * The clinical assessments that will be used are not available in valid and reliable forms for non-English speaking populations.

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