Trial Outcomes & Findings for Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia (NCT NCT02775864)
NCT ID: NCT02775864
Last Updated: 2024-05-01
Results Overview
Number of participants hospitalized for a mental health reason
Recruitment status
COMPLETED
Target enrollment
81921 participants
Primary outcome timeframe
One year
Results posted on
2024-05-01
Participant Flow
Participant milestones
| Measure |
Antipsychotic
Individuals initiating treatment with an antipsychotic medication
Antipsychotic: New initiation of any antipsychotic medication
|
Antidepressant
Individuals initiating treatment with an antidepressant medication
Antidepressant: New initiation of any antidepressant medications
|
Benzodiazepine
Individuals initiating treatment with a benzodiazepine
Benzodiazepine: New initiation of any benzodiazepine
|
Mood Stabilizer
Individuals initiating treatment with a mood stabilizer
Mood stabilizer: New initiation of lithium or any mood stabilizing anti-epileptic drug
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
26014
|
31117
|
11941
|
12849
|
|
Overall Study
COMPLETED
|
22772
|
26218
|
10081
|
10765
|
|
Overall Study
NOT COMPLETED
|
3242
|
4899
|
1860
|
2084
|
Reasons for withdrawal
| Measure |
Antipsychotic
Individuals initiating treatment with an antipsychotic medication
Antipsychotic: New initiation of any antipsychotic medication
|
Antidepressant
Individuals initiating treatment with an antidepressant medication
Antidepressant: New initiation of any antidepressant medications
|
Benzodiazepine
Individuals initiating treatment with a benzodiazepine
Benzodiazepine: New initiation of any benzodiazepine
|
Mood Stabilizer
Individuals initiating treatment with a mood stabilizer
Mood stabilizer: New initiation of lithium or any mood stabilizing anti-epileptic drug
|
|---|---|---|---|---|
|
Overall Study
Data ended end of 2010
|
1764
|
2880
|
1140
|
1194
|
|
Overall Study
Medicaid eligibility discontinued
|
1478
|
2019
|
720
|
890
|
Baseline Characteristics
Comparative Effectiveness of Adaptive Treatment Strategies for Schizophrenia
Baseline characteristics by cohort
| Measure |
Antipsychotic
n=26014 Participants
Individuals initiating treatment with an antipsychotic medication
Antipsychotic: New initiation of any antipsychotic medication
|
Antidepressant
n=31117 Participants
Individuals initiating treatment with an antidepressant medication
Antidepressant: New initiation of any antidepressant medications
|
Benzodiazepine
n=11941 Participants
Individuals initiating treatment with a benzodiazepine
Benzodiazepine: New initiation of any benzodiazepine
|
Mood Stabilizer
n=12849 Participants
Individuals initiating treatment with a mood stabilizer
Mood stabilizer: New initiation of lithium or any mood stabilizing anti-epileptic drug
|
Total
n=81921 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
40.5 years
STANDARD_DEVIATION 12.5 • n=39 Participants
|
40.5 years
STANDARD_DEVIATION 12.4 • n=41 Participants
|
40.5 years
STANDARD_DEVIATION 12.5 • n=35 Participants
|
40.3 years
STANDARD_DEVIATION 12.5 • n=31 Participants
|
40.5 years
STANDARD_DEVIATION 12.5 • n=146 Participants
|
|
Sex: Female, Male
Female
|
11914 Participants
n=39 Participants
|
14283 Participants
n=41 Participants
|
5553 Participants
n=35 Participants
|
5975 Participants
n=31 Participants
|
37725 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
14100 Participants
n=39 Participants
|
16834 Participants
n=41 Participants
|
6388 Participants
n=35 Participants
|
6874 Participants
n=31 Participants
|
44196 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
9645 Participants
n=39 Participants
|
10998 Participants
n=41 Participants
|
5186 Participants
n=35 Participants
|
4261 Participants
n=31 Participants
|
30090 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
10371 Participants
n=39 Participants
|
12459 Participants
n=41 Participants
|
3731 Participants
n=35 Participants
|
5465 Participants
n=31 Participants
|
32026 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
2517 Participants
n=39 Participants
|
3196 Participants
n=41 Participants
|
1159 Participants
n=35 Participants
|
1263 Participants
n=31 Participants
|
8135 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Asian
|
645 Participants
n=39 Participants
|
461 Participants
n=41 Participants
|
252 Participants
n=35 Participants
|
237 Participants
n=31 Participants
|
1595 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Hawaiian or Pacific Islander
|
782 Participants
n=39 Participants
|
744 Participants
n=41 Participants
|
339 Participants
n=35 Participants
|
287 Participants
n=31 Participants
|
2152 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Native American or Alaskan Native
|
240 Participants
n=39 Participants
|
305 Participants
n=41 Participants
|
104 Participants
n=35 Participants
|
87 Participants
n=31 Participants
|
736 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
51 Participants
n=39 Participants
|
67 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
26 Participants
n=31 Participants
|
163 Participants
n=146 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2763 Participants
n=39 Participants
|
2787 Participants
n=41 Participants
|
1152 Participants
n=35 Participants
|
1223 Participants
n=31 Participants
|
7925 Participants
n=146 Participants
|
PRIMARY outcome
Timeframe: One yearNumber of participants hospitalized for a mental health reason
Outcome measures
| Measure |
Antipsychotic
n=26014 Participants
Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine
|
Antidepressant
n=31117 Participants
Individuals initiating treatment with an antidepressant medication
|
Benzodiazepine
n=11941 Participants
Individuals initiating treatment with a benzodiazepine
|
Mood Stabilizer
n=12849 Participants
Individuals initiating treatment with a mood stabilizer
|
|---|---|---|---|---|
|
Psychiatric Hospitalization
|
4965 Participants
|
5247 Participants
|
2385 Participants
|
3093 Participants
|
SECONDARY outcome
Timeframe: One yearNumber of Participants with an Emergency Department visit for mental health reason
Outcome measures
| Measure |
Antipsychotic
n=26014 Participants
Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine
|
Antidepressant
n=31117 Participants
Individuals initiating treatment with an antidepressant medication
|
Benzodiazepine
n=11941 Participants
Individuals initiating treatment with a benzodiazepine
|
Mood Stabilizer
n=12849 Participants
Individuals initiating treatment with a mood stabilizer
|
|---|---|---|---|---|
|
Emergency Department Visit for Mental Health Reason
|
5505 Participants
|
6508 Participants
|
2930 Participants
|
3429 Participants
|
SECONDARY outcome
Timeframe: One yearParticipants who died
Outcome measures
| Measure |
Antipsychotic
n=26014 Participants
Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine
|
Antidepressant
n=31117 Participants
Individuals initiating treatment with an antidepressant medication
|
Benzodiazepine
n=11941 Participants
Individuals initiating treatment with a benzodiazepine
|
Mood Stabilizer
n=12849 Participants
Individuals initiating treatment with a mood stabilizer
|
|---|---|---|---|---|
|
Death
|
259 Participants
|
327 Participants
|
204 Participants
|
161 Participants
|
Adverse Events
Antipsychotic
Serious events: 67 serious events
Other events: 967 other events
Deaths: 259 deaths
Antidepressant
Serious events: 102 serious events
Other events: 1004 other events
Deaths: 327 deaths
Benzodiazepine
Serious events: 43 serious events
Other events: 424 other events
Deaths: 204 deaths
Mood Stabilizer
Serious events: 41 serious events
Other events: 423 other events
Deaths: 161 deaths
Serious adverse events
| Measure |
Antipsychotic
n=21738 participants at risk；n=26014 participants at risk
Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine)
|
Antidepressant
n=26062 participants at risk；n=31117 participants at risk
Individuals initiating treatment with an antidepressant medication
|
Benzodiazepine
n=9764 participants at risk；n=11941 participants at risk
Individuals initiating treatment with a benzodiazepine
|
Mood Stabilizer
n=10564 participants at risk；n=12849 participants at risk
Individuals initiating treatment with a mood stabilizer
|
|---|---|---|---|---|
|
Cardiac disorders
Admission for Cardiovascular Disease
|
0.26%
67/26014 • 365 days
|
0.33%
102/31117 • 365 days
|
0.36%
43/11941 • 365 days
|
0.32%
41/12849 • 365 days
|
Other adverse events
| Measure |
Antipsychotic
n=21738 participants at risk；n=26014 participants at risk
Individuals initiating treatment with another second-generation antipsychotic medication (other than clozapine)
|
Antidepressant
n=26062 participants at risk；n=31117 participants at risk
Individuals initiating treatment with an antidepressant medication
|
Benzodiazepine
n=9764 participants at risk；n=11941 participants at risk
Individuals initiating treatment with a benzodiazepine
|
Mood Stabilizer
n=10564 participants at risk；n=12849 participants at risk
Individuals initiating treatment with a mood stabilizer
|
|---|---|---|---|---|
|
Endocrine disorders
Incident cases of diabetes mellitus
|
4.4%
967/21738 • Number of events 967 • 365 days
|
3.9%
1004/26062 • Number of events 1004 • 365 days
|
4.3%
424/9764 • Number of events 424 • 365 days
|
4.0%
423/10564 • Number of events 423 • 365 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place