Trial · Interventional

CompletedPhase 4Results postedRegistry data

Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia

NCTNCT02417142Other id13T-005

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 70 participants (actual)
Sponsor: University of Massachusetts, Worcester · Other
Design: Randomized · Double masking
Countries: 1 country
United States
Start: Sept 2014
Primary completion: Jul 2019
Completion: Jul 2020
First posted: 15 Apr 2015 (estimated)
Last update posted: 14 Jan 2022
Conditions: Schizophrenia · Schizoaffective Disorder

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2014201620182020

Ph 4
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
NCT02417142
Sept 2014 to Jul 2020

Registry summary

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

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.

Interventions

ExenatideDrug
PlaceboDrug

Arms2

Experimental
Experimental
Exenatide 2mg subcutaneous injection, once weekly
Placebo comparator
Placebo
Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Time frame · Baseline, Week 6, Week 12, Week 18 and Week 24
Registry description
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.

Secondary outcomes(1)

Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score
Time frame · Baseline, Week 6, Week 12, Week 18, and Week 24.
Registry description
The MATRICS Consensus Cognitive Battery (MCCB) measures cognition relevant to schizophrenia and related disorders. The MCCB consists of ten individually administered tests that measure cognitive performance in seven domains including speed of processing, attention/vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition. The raw scores from the ten tests are entered in the MCCB Computer Scoring Program software, which provides an age and gender-corrected T-score and percentile on the seven cognitive domains. A T-score of 50 +/- 10 represents a normative mean performance in each test. Accordingly, the criterion for assignment to cognitively normal-range group require an overall composite T-score from 40 to 60. These data points from baseline visit to week 24 will measure changes in cognition in addition overall cognitive ability compared to healthy individuals.

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

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

Group	Value (score on a scale)	Spread
Experimental	33.1	12.9
Placebo	34.1	15.0

Secondary and other outcome results(1)

Secondary outcomeMean· Baseline, Week 6, Week 12, Week 18, and Week 24.

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

Group	Value (score on a scale)	Spread
Experimental	26.9	17.2
Placebo	24.7	12.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Experimental(existing treatment) + (Drug) Intervention: Drug: Exenatide Exenatide: Exenatide IM 2mg/week for 24 weeks.	0 / 35	0 / 35	29 / 35
Placebo(existing treatment) + (Placebo) Intervention: Drug: Placebo Placebo: Placebo IM for 24 weeks.	0 / 35	0 / 35	27 / 35

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: * 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 Exclusion Criteria: * 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

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