Primary outcome
What NCT02417142 measured first
| Measure | Experimentaln=35 | Placebon=35 |
|---|---|---|
| Baseline | 33.1(12.9) | 34.1(15.0) |
| Week 6 | 34.1(2.3) | 32.8(11.8) |
| Week 12 | 35.8(13.0) | 34.5(11.5) |
| Week 18 | 36.1(11.9) | 35.2(10.2) |
| Week 24 | 35.2(13.3) | 35.0(11.1) |
Phase 4 · Exenatide
NCT02417142 trial results
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
- Participants
- 70
- Status
- completed
- Completed
- 2020-07
- Sponsor
- University of Massachusetts, Worcester
As posted on ClinicalTrials.gov (NCT02417142), updated at source Jan 14, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.
Side effects by arm
Side effects in NCT02417142
Percent of participants affected, 24 weeks. The most common events the registry lists.
| Event | Experimental | Placebo |
|---|---|---|
| Any serious event | 0% | 0% |
| Bump at injection site | 48.6% | 0% |
| Headache | 25.7% | 28.6% |
| Heartburn | 14.3% | 22.9% |
| Constipation | 14.3% | 22.9% |
| Itchiness at injection site | 22.9% | 0% |
| Irritability/anxiety | 20% | 8.6% |
| Vomiting | 5.7% | 17.1% |
| Nausea | 11.4% | 5.7% |
| Diarrhea | 8.6% | 8.6% |
| Dizziness | 8.6% | 8.6% |
| Abdominal pain | 8.6% | 2.9% |
| Fatigue | 8.6% | 5.7% |
| Indigestion | 8.6% | 2.9% |
| Chest pain | 8.6% | 0% |
| Suicidal Ideation | 5.7% | 8.6% |
| Hunger | 5.7% | 5.7% |
| Decreased appetite | 5.7% | 2.9% |
| Sedation | 5.7% | 2.9% |
| Blurry vision | 5.7% | 0% |
Secondary outcomes
What else it measured
| Measure | Experimentaln=35 | Placebon=35 |
|---|---|---|
| Baseline | 26.9(17.2) | 24.7(12.6) |
| Week 6 | 27.3(17.3) | 27.2(15.4) |
| Week 12 | 28.4(17.3) | 28.1(16.2) |
| Week 18 | 28.7(18.1) | 32.2(15.1) |
| Week 24 | 31.2(16.5) | 33.9(14.4) |
The trial
How NCT02417142 was run
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.
- Experimental: Exenatide 2mg subcutaneous injection, once weekly
- Placebo: Placebo
Who could join the trial
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
Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.
GLPcompare is an informational data platform, not a medical provider or pharmacy. Nothing here is medical advice, a diagnosis, or a recommendation to start, stop, or change any treatment. Data is aggregated from public sources and can be incomplete or out of date. Always confirm with a licensed clinician and the current FDA label.