Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia

NCT02417142 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 13T-005
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 24-week, randomized, double-blind, placebo-controlled trial of exenatide weekly injection (2mg per dose) as an adjunctive therapy in 70 schizophrenia subjects to examine exenatide's effects on negative symptoms and cognition.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

• Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score

  SANS measures negative symptoms on a 25-item, six point scale each (0-5; none-severe). Items are listed under five domains including affective flattening or blunting, alogia, avolition/apathy, anhedonia/asociality, and attention. The total possible score ranges from 0 to 125.

  Baseline, Week 6, Week 12, Week 18 and Week 24

Secondary Outcomes (1)

• Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score

  Baseline, Week 6, Week 12, Week 18, and Week 24.

Study Arms (2)

Experimental

EXPERIMENTAL

Exenatide 2mg subcutaneous injection, once weekly

Drug: Exenatide

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Exenatide DRUG

Exenatide SQ 2mg/week for 24 weeks.

Also known as: Bydureon

Experimental

Placebo DRUG

Placebo SQ 1x/week for 24 weeks.

Also known as: Control

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age 18-65 years
• diagnosis of schizophrenia or schizoaffective disorder
• stable dose of the current antipsychotic drug for at least one month
• well established compliance with outpatient treatment per treating clinician's judgment
• able to complete the cognitive assessment battery (must be English speaking)
• Female subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods during the study

You may not qualify if:

• inability to provide informed consent
• current substance abuse
• psychiatrically unstable per treating clinician's judgment
• significant medical illnesses including uncontrolled hypertension, diabetes, seizure disorder, severe cardiovascular, cerebrovascular, pulmonary, or thyroid diseases
• currently on anti-inflammatory or immunosuppressant medication including oral steroids
• currently on sulfonylurea drugs (e.g. glyburide)
• history of chronic infection (including tuberculosis, HIV and hepatitis), malignancy, organ transplantation, blood dyscrasia, central nervous system demyelinating disorder, and any other known autoimmune or inflammatory condition
• pregnant or breastfeeding
• prisoners

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

UMass Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

Exenatide

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Peptides; Amino Acids, Peptides, and Proteins; Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Xiaoduo Fan, MD, MPH
• Organization: UMass Medical School

xiaoduo.fan@umassmed.edu

(508) 856 -3881

Study Officials

• Xiaoduo Fan, MD, MPH, MS

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Xiaoduo Fan, MD, MPH, MS

Study Record Dates

• First Submitted: April 10, 2015
• First Posted: April 15, 2015
• Study Start: September 1, 2014
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: January 14, 2022
• Results First Posted: June 15, 2021

Record last verified: 2022-01

Locations

US (1)