Trial Outcomes & Findings for A Comparison of Long-acting Injectable Medications for Schizophrenia (NCT NCT01136772)
NCT ID: NCT01136772
Last Updated: 2016-10-21
Results Overview
Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.
COMPLETED
PHASE4
311 participants
24 months
2016-10-21
Participant Flow
Participant milestones
| Measure |
Paliperidone Palmitate
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
154
|
|
Overall Study
Safety Population
|
147
|
147
|
|
Overall Study
COMPLETED
|
41
|
44
|
|
Overall Study
NOT COMPLETED
|
116
|
110
|
Reasons for withdrawal
| Measure |
Paliperidone Palmitate
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
|---|---|---|
|
Overall Study
Adverse Event
|
15
|
14
|
|
Overall Study
Lack of Efficacy
|
42
|
39
|
|
Overall Study
Administrative
|
14
|
12
|
|
Overall Study
Withdrawal by Subject
|
33
|
36
|
|
Overall Study
Did not receive injection
|
10
|
7
|
|
Overall Study
Did not follow up after first injection
|
2
|
2
|
Baseline Characteristics
A Comparison of Long-acting Injectable Medications for Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone Palmitate
n=145 Participants
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
n=145 Participants
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
Total
n=290 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 12.6 • n=93 Participants
|
45 years
STANDARD_DEVIATION 12.3 • n=4 Participants
|
44 years
STANDARD_DEVIATION 12.4 • n=27 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=93 Participants
|
35 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=93 Participants
|
110 Participants
n=4 Participants
|
216 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All randomized participants who received an injection and attended one follow-up appointment
Efficacy failure as indicated by psychiatric hospitalization, need for crisis intervention, clinical decision that oral antipsychotic medication cannot be discontinued in less than eight weeks, a clinical decision to discontinue the medication due to inadequate benefit, or the ongoing or repeated need for adjunctive antipsychotic medication.
Outcome measures
| Measure |
Paliperidone Palmitate
n=145 Participants
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
n=145 Participants
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
|---|---|---|
|
Efficacy Failure
|
49 participants
|
47 participants
|
SECONDARY outcome
Timeframe: Baseline to 6 monthsPopulation: Participants with PANSS scores at 6 months
The Positive and Negative Syndrome Scale measures the core symptoms associated with schizophrenia. The measure includes 30 items rated from 1=absent to 7=extremely severe. Full range of scores is 30-210 with higher scores representing more severe illness. Reductions in symptoms over time represent improvement.
Outcome measures
| Measure |
Paliperidone Palmitate
n=91 Participants
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
n=88 Participants
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
|---|---|---|
|
Changes in Psychiatric Symptoms
|
-6.87 Units on a scale
Interval -8.79 to -4.94
|
-6.40 Units on a scale
Interval -8.32 to -4.48
|
Adverse Events
Paliperidone Palmitate
Haloperidol Decanoate
Serious adverse events
| Measure |
Paliperidone Palmitate
n=147 participants at risk
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
n=147 participants at risk
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
13.6%
20/147
|
10.9%
16/147
|
|
Psychiatric disorders
Suicidal Act
|
1.4%
2/147
|
3.4%
5/147
|
|
Psychiatric disorders
Homicidal ideation
|
5.4%
8/147
|
4.8%
7/147
|
|
Psychiatric disorders
Homocidal Act
|
0.00%
0/147
|
0.68%
1/147
|
|
Psychiatric disorders
Violent ideation
|
1.4%
2/147
|
2.0%
3/147
|
|
Psychiatric disorders
Violent act
|
0.00%
0/147
|
1.4%
2/147
|
|
Psychiatric disorders
Psychiatric hospitalization
|
29.9%
44/147
|
23.1%
34/147
|
Other adverse events
| Measure |
Paliperidone Palmitate
n=147 participants at risk
Intramuscular injections of paliperidone palmitate 39-234 mg every month
|
Haloperidol Decanoate
n=147 participants at risk
Intramuscular injections of haloperidol decanoate 25-200 mg every month
|
|---|---|---|
|
Psychiatric disorders
Insomnia
|
33.3%
49/147
|
36.7%
54/147
|
|
Psychiatric disorders
Sleepiness
|
27.9%
41/147
|
29.9%
44/147
|
|
Gastrointestinal disorders
Dry mouth
|
27.2%
40/147
|
23.1%
34/147
|
|
General disorders
Increased appetite
|
22.4%
33/147
|
17.7%
26/147
|
|
Psychiatric disorders
Hypersomnia
|
16.3%
24/147
|
13.6%
20/147
|
|
General disorders
Sialorrhea
|
16.3%
24/147
|
10.9%
16/147
|
|
Gastrointestinal disorders
Constipation
|
14.3%
21/147
|
13.6%
20/147
|
|
Cardiac disorders
Orthostatic faintness
|
9.5%
14/147
|
8.2%
12/147
|
|
Renal and urinary disorders
Incontinence/nocturia
|
8.8%
13/147
|
5.4%
8/147
|
|
Reproductive system and breast disorders
Menstrual irregularities
|
8.2%
12/147
|
3.4%
5/147
|
|
Renal and urinary disorders
Urinary hesitancy
|
4.8%
7/147
|
6.1%
9/147
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place