Trial Outcomes & Findings for High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia (NCT NCT01569659)
NCT ID: NCT01569659
Last Updated: 2025-02-28
Results Overview
Specify Full Scale Name and Construct: Positive and Negative Symptom Scale (PANSS) Scale description: A 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. These 30 items are split into three categories (Positive, Negative and General Psychopathology symptoms of schizophrenia), and the information is used to evaluate the presence, absence and severity of each. A score of 1 on an item indicates the absence of the symptom, up to a 7 which indicates the presence of the symptom is extreme. The minimum and maximum for the whole scale would be 30-210, and for each of the three categories are as follows: Positive scale (7 Items)--minimum score = 7, maximum score = 49; Negative scale (7 Items)--minimum score = 7, maximum score = 49; General Psychopathology scale (16 Items)--minimum score = 16, maximum score = 112.
COMPLETED
PHASE4
101 participants
Baseline to end of randomized phase (24 weeks)
2025-02-28
Participant Flow
101 subject were enrolled in phase 1 for a period of 6 weeks to determine Treatment Resistant Status (TRS). 34 determined NOT TRS so were discontinued. The remaining 67 moved to phase 2. 34 remained in standard dose of Lurasidone and 44 were on High dose Lurasidone.
Participant milestones
| Measure |
Standard Dose of Lurasidone
Only those patients who still have persistent moderate to severe positive symptoms, even if they have shown some improvement at 80 mg/day will proceed to phase II (randomization). In phase II, 30 subjects will be randomized to continue 80 mg lurasidone.
Lurasidone: 80 mg/day for up to 30 weeks
|
High Dose of Lurasidone
In phase II, 40 patients will initiate a titration schedule, beginning at 120 mg at week 7. The high-dose group will be increased an additional 40 mg/day every week, thereafter, to a total of 240 mg/day, if adequately tolerated, which would include a worsening of psychopathology as assessed by the PANSS or Clinical Global Impressions-Severity (CGI-S). The dose will remain at 240/day, or the highest dose tolerated, for a duration of 6 months from the time the 120 mg/day dose was initiated.
Lurasidone: Up to 240 mg/day for up to 30 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
33
|
|
Overall Study
COMPLETED
|
22
|
22
|
|
Overall Study
NOT COMPLETED
|
12
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Baseline characteristics by cohort
| Measure |
Standard Dose of Lurasidone
n=34 Participants
Only those patients who still have persistent moderate to severe positive symptoms, even if they have shown some improvement at 80 mg/day will proceed to phase II (randomization). In phase II, 30 subjects will be randomized to continue 80 mg lurasidone.
Lurasidone: 80 mg/day for up to 30 weeks
|
High Dose of Lurasidone
n=33 Participants
In phase II, 40 patients will initiate a titration schedule, beginning at 120 mg at week 7. The high-dose group will be increased an additional 40 mg/day every week, thereafter, to a total of 240 mg/day, if adequately tolerated, which would include a worsening of psychopathology as assessed by the PANSS or CGI-S. The dose will remain at 240/day, or the highest dose tolerated, for a duration of 6 months from the time the 120 mg/day dose was initiated.
Lurasidone: Up to 240 mg/day for up to 30 weeks
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
45.2 years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
46.1 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
33 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of randomized phase (24 weeks)Population: Participants with baseline persistent moderate to severe positive symptoms
Specify Full Scale Name and Construct: Positive and Negative Symptom Scale (PANSS) Scale description: A 45-minute clinical interview is conducted. The patient is rated from 1 to 7 on 30 different symptoms based on the interview as well as reports of family members or primary care hospital workers. These 30 items are split into three categories (Positive, Negative and General Psychopathology symptoms of schizophrenia), and the information is used to evaluate the presence, absence and severity of each. A score of 1 on an item indicates the absence of the symptom, up to a 7 which indicates the presence of the symptom is extreme. The minimum and maximum for the whole scale would be 30-210, and for each of the three categories are as follows: Positive scale (7 Items)--minimum score = 7, maximum score = 49; Negative scale (7 Items)--minimum score = 7, maximum score = 49; General Psychopathology scale (16 Items)--minimum score = 16, maximum score = 112.
Outcome measures
| Measure |
Standard Dose of Lurasidone
n=34 Participants
Only those patients who still have persistent moderate to severe positive symptoms, even if they have shown some improvement at 80 mg/day will proceed to phase II (randomization). In phase II, 30 subjects will be randomized to continue 80 mg lurasidone.
Lurasidone: 80 mg/day for up to 30 weeks
|
High Dose of Lurasidone
n=33 Participants
In phase II, 40 patients will initiate a titration schedule, beginning at 120 mg at week 7. The high-dose group will be increased an additional 40 mg/day every week, thereafter, to a total of 240 mg/day, if adequately tolerated, which would include a worsening of psychopathology as assessed by the PANSS or CGI-S. The dose will remain at 240/day, or the highest dose tolerated, for a duration of 6 months from the time the 120 mg/day dose was initiated.
Lurasidone: Up to 240 mg/day for up to 30 weeks
|
|---|---|---|
|
Change in Positive Symptoms of Schizophrenia
|
22.6 units on a scale
Standard Deviation 3.3
|
24.2 units on a scale
Standard Deviation 4.3
|
Adverse Events
Standard Dose of Lurasidone
High Dose of Lurasidone
Serious adverse events
| Measure |
Standard Dose of Lurasidone
n=34 participants at risk
Only those patients who still have persistent moderate to severe positive symptoms, even if they have shown some improvement at 80 mg/day will proceed to phase II (randomization). In phase II, 30 subjects will be randomized to continue 80 mg lurasidone.
Lurasidone: 80 mg/day for up to 30 weeks
|
High Dose of Lurasidone
n=33 participants at risk
In phase II, 40 patients will initiate a titration schedule, beginning at 120 mg at week 7. The high-dose group will be increased an additional 40 mg/day every week, thereafter, to a total of 240 mg/day, if adequately tolerated, which would include a worsening of psychopathology as assessed by the PANSS or CGI-S. The dose will remain at 240/day, or the highest dose tolerated, for a duration of 6 months from the time the 120 mg/day dose was initiated.
Lurasidone: Up to 240 mg/day for up to 30 weeks
|
|---|---|---|
|
Cardiac disorders
Death
|
0.00%
0/34
|
3.0%
1/33 • Number of events 1
|
Other adverse events
| Measure |
Standard Dose of Lurasidone
n=34 participants at risk
Only those patients who still have persistent moderate to severe positive symptoms, even if they have shown some improvement at 80 mg/day will proceed to phase II (randomization). In phase II, 30 subjects will be randomized to continue 80 mg lurasidone.
Lurasidone: 80 mg/day for up to 30 weeks
|
High Dose of Lurasidone
n=33 participants at risk
In phase II, 40 patients will initiate a titration schedule, beginning at 120 mg at week 7. The high-dose group will be increased an additional 40 mg/day every week, thereafter, to a total of 240 mg/day, if adequately tolerated, which would include a worsening of psychopathology as assessed by the PANSS or CGI-S. The dose will remain at 240/day, or the highest dose tolerated, for a duration of 6 months from the time the 120 mg/day dose was initiated.
Lurasidone: Up to 240 mg/day for up to 30 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
23.5%
8/34 • Number of events 8
|
27.3%
9/33 • Number of events 9
|
|
Nervous system disorders
Insomnia
|
17.6%
6/34 • Number of events 6
|
12.1%
4/33 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
11.8%
4/34 • Number of events 4
|
6.1%
2/33 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.7%
5/34 • Number of events 5
|
6.1%
2/33 • Number of events 2
|
|
Nervous system disorders
Headache
|
8.8%
3/34 • Number of events 3
|
15.2%
5/33 • Number of events 5
|
|
Nervous system disorders
Suicidality
|
5.9%
2/34 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
3/34 • Number of events 3
|
3.0%
1/33 • Number of events 1
|
|
Nervous system disorders
Akathasia
|
5.9%
2/34 • Number of events 2
|
9.1%
3/33 • Number of events 3
|
|
Infections and infestations
Coughing
|
5.9%
2/34 • Number of events 2
|
6.1%
2/33 • Number of events 2
|
|
Gastrointestinal disorders
Emesis
|
5.9%
2/34 • Number of events 2
|
3.0%
1/33 • Number of events 1
|
|
Metabolism and nutrition disorders
Weight gain
|
5.9%
2/34 • Number of events 2
|
0.00%
0/33
|
|
Nervous system disorders
Aggression
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypnatremia
|
0.00%
0/34
|
6.1%
2/33 • Number of events 2
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place