Trial Outcomes & Findings for Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia (NCT NCT02417142)
NCT ID: NCT02417142
Last Updated: 2022-01-14
Results Overview
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.
COMPLETED
PHASE4
70 participants
Baseline, Week 6, Week 12, Week 18 and Week 24
2022-01-14
Participant Flow
Single-site study conducted at University of Massachusetts (UMass) Medical School. Subjects were recruited from UMass Memorial Healthcare facilities and ambulatory clinics in Worcester, MA.
Subjects who met DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, 4th Edition) criteria for schizophrenia or schizoaffective disorder were enrolled in the study (see inclusion/exclusion criteria). Eligible subjects were randomly assigned to either the experimental or placebo group.
Participant milestones
| Measure |
Experimental
(existing treatment) + (Drug)
Intervention:
Drug: Exenatide
Exenatide: Exenatide 2mg/week subcutaneous injection for 24 weeks.
|
Placebo
(existing treatment) + (Placebo)
Intervention:
Drug: Placebo
Placebo: Placebo IM for 24 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
16
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Exenatide Weekly Injections as an Adjunctive Treatment in Patients With Schizophrenia
Baseline characteristics by cohort
| Measure |
Experimental
n=35 Participants
(existing treatment) + (Drug)
Intervention:
Drug: Exenatide
Exenatide: Exenatide IM 2mg/week for 24 weeks.
|
Placebo
n=35 Participants
(existing treatment) + (Placebo)
Intervention:
Drug: Placebo
Placebo: Placebo IM for 24 weeks.
|
Total
n=70 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.6 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
43.9 years
STANDARD_DEVIATION 11.9 • n=107 Participants
|
42.7 years
STANDARD_DEVIATION 12.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
55 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Mixed
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Unknown/Not reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
35 Participants
n=99 Participants
|
35 Participants
n=107 Participants
|
70 Participants
n=206 Participants
|
|
Education
|
12.9 years
STANDARD_DEVIATION 2.4 • n=99 Participants
|
12.7 years
STANDARD_DEVIATION 2.1 • n=107 Participants
|
12.8 years
STANDARD_DEVIATION 2.3 • n=206 Participants
|
|
Age of illness onset
|
23.7 years
STANDARD_DEVIATION 8.3 • n=99 Participants
|
24.6 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
24.2 years
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Duration of illness
|
18.1 years
STANDARD_DEVIATION 12.2 • n=99 Participants
|
18.9 years
STANDARD_DEVIATION 10.1 • n=107 Participants
|
18.5 years
STANDARD_DEVIATION 11.2 • n=206 Participants
|
|
Schizophrenia
|
19 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Schizoaffective disorder
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Typical antipsychotic medication
Yes
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Typical antipsychotic medication
No
|
26 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Atypical antipsychotic medication
Yes
|
27 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Atypical antipsychotic medication
No
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6, Week 12, Week 18 and Week 24Population: 12 subjects in experimental arm withdrew or were lost to follow-up by week 24. 4 subjects in the experimental arm were removed from study by investigator by week 24. 11 subjects in placebo arm withdrew or were lost to follow-up by week 24. 2 subjects in the placebo arm were removed from study by investigator by week 24. Reasons for removal include inpatient hospitalization, increase in depressive symptoms, elevated HbA1c, starting insulin therapy and repeatedly missing visits.
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.
Outcome measures
| Measure |
Experimental
n=35 Participants
(existing treatment) + (Drug)
Intervention:
Drug: Exenatide
Exenatide: Exenatide IM 2mg/week for 24 weeks.
|
Placebo
n=35 Participants
(existing treatment) + (Placebo)
Intervention:
Drug: Placebo
Placebo: Placebo IM for 24 weeks.
|
|---|---|---|
|
Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Baseline
|
33.1 score on a scale
Standard Deviation 12.9
|
34.1 score on a scale
Standard Deviation 15.0
|
|
Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Week 6
|
34.1 score on a scale
Standard Deviation 2.3
|
32.8 score on a scale
Standard Deviation 11.8
|
|
Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Week 12
|
35.8 score on a scale
Standard Deviation 13.0
|
34.5 score on a scale
Standard Deviation 11.5
|
|
Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Week 18
|
36.1 score on a scale
Standard Deviation 11.9
|
35.2 score on a scale
Standard Deviation 10.2
|
|
Negative Symptoms as Measured by the Scale for the Assessment of Negative Symptoms (SANS) Total Score
Week 24
|
35.2 score on a scale
Standard Deviation 13.3
|
35.0 score on a scale
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: Baseline, Week 6, Week 12, Week 18, and Week 24.Population: 12 subjects in experimental arm withdrew or were lost to follow-up by week 24. 4 subjects in the experimental arm were removed from study by investigator by week 24. 11 subjects in placebo arm withdrew or were lost to follow-up by week 24. 2 subjects in the placebo arm were removed from study by investigator by week 24. Reasons for removal include inpatient hospitalization, increase in depressive symptoms, elevated HbA1c, starting insulin and repeatedly missing visits during study period.
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.
Outcome measures
| Measure |
Experimental
n=35 Participants
(existing treatment) + (Drug)
Intervention:
Drug: Exenatide
Exenatide: Exenatide IM 2mg/week for 24 weeks.
|
Placebo
n=35 Participants
(existing treatment) + (Placebo)
Intervention:
Drug: Placebo
Placebo: Placebo IM for 24 weeks.
|
|---|---|---|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score
Baseline
|
26.9 score on a scale
Standard Deviation 17.2
|
24.7 score on a scale
Standard Deviation 12.6
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score
Week 6
|
27.3 score on a scale
Standard Deviation 17.3
|
27.2 score on a scale
Standard Deviation 15.4
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score
Week 12
|
28.4 score on a scale
Standard Deviation 17.3
|
28.1 score on a scale
Standard Deviation 16.2
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score
Week 18
|
28.7 score on a scale
Standard Deviation 18.1
|
32.2 score on a scale
Standard Deviation 15.1
|
|
Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) Composite T-score
Week 24
|
31.2 score on a scale
Standard Deviation 16.5
|
33.9 score on a scale
Standard Deviation 14.4
|
Adverse Events
Experimental
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental
n=35 participants at risk
(existing treatment) + (Drug)
Intervention:
Drug: Exenatide
Exenatide: Exenatide IM 2mg/week for 24 weeks.
|
Placebo
n=35 participants at risk
(existing treatment) + (Placebo)
Intervention:
Drug: Placebo
Placebo: Placebo IM for 24 weeks.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Bump at injection site
|
48.6%
17/35 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
General disorders
Headache
|
25.7%
9/35 • 24 weeks
|
28.6%
10/35 • 24 weeks
|
|
Gastrointestinal disorders
Heartburn
|
14.3%
5/35 • 24 weeks
|
22.9%
8/35 • 24 weeks
|
|
Gastrointestinal disorders
Constipation
|
14.3%
5/35 • 24 weeks
|
22.9%
8/35 • 24 weeks
|
|
Skin and subcutaneous tissue disorders
Itchiness at injection site
|
22.9%
8/35 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
General disorders
Nausea
|
11.4%
4/35 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Psychiatric disorders
Irritability/anxiety
|
20.0%
7/35 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Gastrointestinal disorders
Vomiting
|
5.7%
2/35 • 24 weeks
|
17.1%
6/35 • 24 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
8.6%
3/35 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
General disorders
Dizziness
|
8.6%
3/35 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
8.6%
3/35 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Fatigue
|
8.6%
3/35 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Gastrointestinal disorders
Indigestion
|
8.6%
3/35 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Cardiac disorders
Chest pain
|
8.6%
3/35 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
|
General disorders
Hunger
|
5.7%
2/35 • 24 weeks
|
5.7%
2/35 • 24 weeks
|
|
Psychiatric disorders
Suicidal Ideation
|
5.7%
2/35 • 24 weeks
|
8.6%
3/35 • 24 weeks
|
|
General disorders
Decreased appetite
|
5.7%
2/35 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
General disorders
Sedation
|
5.7%
2/35 • 24 weeks
|
2.9%
1/35 • 24 weeks
|
|
Eye disorders
Blurry vision
|
5.7%
2/35 • 24 weeks
|
0.00%
0/35 • 24 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place