Trial Outcomes & Findings for Switching Medication to Treat Schizophrenia (NCT NCT00044655)
NCT ID: NCT00044655
Last Updated: 2026-05-15
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
219 participants
Primary outcome timeframe
Measured at Six Months
Results posted on
2026-05-15
Participant Flow
Participant milestones
| Measure |
Stay
Participants will continue taking medication prescribed at study entry
|
Switch
Participants will change medications from medication prescribed at study entry
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
117
|
|
Overall Study
COMPLETED
|
82
|
79
|
|
Overall Study
NOT COMPLETED
|
20
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Switching Medication to Treat Schizophrenia
Baseline characteristics by cohort
| Measure |
Stay
n=102 Participants
Participants will continue taking medication prescribed at study entry
|
Switch
n=117 Participants
Participants will change medications from medication prescribed at study entry
|
Total
n=438 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=102 Participants
|
0 Participants
n=117 Participants
|
0 Participants
n=219 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
96 Participants
n=102 Participants
|
112 Participants
n=117 Participants
|
208 Participants
n=219 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=102 Participants
|
5 Participants
n=117 Participants
|
11 Participants
n=219 Participants
|
|
Age, Continuous
|
46.9 years
STANDARD_DEVIATION 10.4 • n=102 Participants
|
47.7 years
STANDARD_DEVIATION 11.3 • n=117 Participants
|
46.9 years
STANDARD_DEVIATION 11.0 • n=219 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=102 Participants
|
31 Participants
n=117 Participants
|
73 Participants
n=219 Participants
|
|
Sex: Female, Male
Male
|
60 Participants
n=102 Participants
|
86 Participants
n=117 Participants
|
146 Participants
n=219 Participants
|
|
Region of Enrollment
United States
|
102 participants
n=102 Participants
|
117 participants
n=117 Participants
|
219 participants
n=219 Participants
|
PRIMARY outcome
Timeframe: Measured at Six MonthsPopulation: intent to treat samples for 2 substudies: injectable to injectable and polypharmacy to monotherapy
Outcome measures
| Measure |
Stay
n=92 Participants
Participants will continue taking medication prescribed at study entry
|
Switch
n=97 Participants
Participants will change medications from medication prescribed at study entry
|
|---|---|---|
|
Number Who Discontinued Medication Within First 6 Study Months
|
11 participants
|
23 participants
|
SECONDARY outcome
Timeframe: during first 6 monthsNumber of participants hospitalized for psychiatric reasons
Outcome measures
| Measure |
Stay
n=92 Participants
Participants will continue taking medication prescribed at study entry
|
Switch
n=97 Participants
Participants will change medications from medication prescribed at study entry
|
|---|---|---|
|
Number of Participants Hospitalized
|
8 Participants
|
9 Participants
|
Adverse Events
Stay
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Switch
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stay
n=102 participants at risk
Participants will continue taking medication prescribed at study entry
|
Switch
n=117 participants at risk
Participants will change medications from medication prescribed at study entry
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization
|
0.00%
0/102
|
0.85%
1/117 • Number of events 1
|
|
Cardiac disorders
Death
|
0.00%
0/102
|
0.85%
1/117 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place