Trial Outcomes & Findings for Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia (NCT NCT00158223)
NCT ID: NCT00158223
Last Updated: 2015-04-09
Results Overview
Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.
COMPLETED
PHASE4
76 participants
Variable change from baseline to week 12
2015-04-09
Participant Flow
Subjects recruited from inpatient and outpatient treatment settings at Mount Sinai Hospital, Pilgrim Psychiatric Center and Manhattan Psychiatric Center in New York.
16 subjects were excluded during the 4-week symptom stability-screening period before randomization because of withdrawal of consent or a failure to meet inclusion and exclusion criteria. Seven additional subjects were randomized to a haloperidol adjunctive pilot study.
Participant milestones
| Measure |
Placebo
Participants received encapsulated placebo made to match active drug
|
Pimozide
Participants received pimozide flexible dosing
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
25
|
|
Overall Study
COMPLETED
|
23
|
22
|
|
Overall Study
NOT COMPLETED
|
5
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effectiveness of Pimozide in Augmenting the Effects of Clozapine in the Treatment of Schizophrenia
Baseline characteristics by cohort
| Measure |
Placebo
n=28 Participants
Participants received encapsulated placebo made to match active drug
|
Pimozide
n=25 Participants
Participants received pimozide flexible dosing
|
Total
n=53 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.4 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
45.5 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
44.9 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Treatment Setting
Inpatient
|
19 participants
n=5 Participants
|
15 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Treatment Setting
Outpatient
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Variable change from baseline to week 12Severity of positive schizophrenic symptoms The Positive Syndrome Scale of the PANSS is comprised of seven items measuring positive such symptoms such as hallucinations, delusions, grandiosity, etc. Each item is scored on a 7 point scale of that particular symptom's severity, ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The PANSS Positive Subscale seven items has a range of a summed score from 7 (absent) to 49 (extreme psychopathology). Therefore, the higher the score, the more severe the symtpoms.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received encapsulated placebo made to match active drug
|
Pimozide
n=22 Participants
Participants received pimozide flexible dosing
|
|---|---|---|
|
Positive Syndrome Scale (PANSS) Total Score
|
-1.05 units on a scale
Standard Deviation 2.98
|
-1.30 units on a scale
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: Variable change from baseline to week 12Severity of negative schizophrenic symptoms, The Negative Syndrome scale is compromised of seven items, each scored on severity with numeric assignments ranging from 1 = absent, 2 = minimal, 3 = mild, 4 = moderate, 5 = moderate severe, 6 = severe, and 7 = extreme. The items which comprise the Negative Syndrome Scale of the PANSS measure things such as emotional withdrawal, apathy, difficulty in abstract thinking, etc. The seven items which comprise the PANSS Negative Subscale has an aggregate range of 7 (absent) to 49 (extreme psychopathology), a higher score indicating more severe symptoms.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received encapsulated placebo made to match active drug
|
Pimozide
n=22 Participants
Participants received pimozide flexible dosing
|
|---|---|---|
|
Negative Syndrome Scale (PANSS) Total Score
|
-1.59 units on a scale
Standard Deviation 4.46
|
0.65 units on a scale
Standard Deviation 4.65
|
SECONDARY outcome
Timeframe: variable change from baseline to week 12The Clinical Global Impression-improvement (CGI-improvement) scale is a research rating tool, developed for use in NIMH-sponsored clinical trials provides a brief assessment of the clinician's view of the patient's overall clinical improvement prior to and after initiating a study medication. The CGI-change is rated on a seven point scale ranging from 1= very much improved since the initiation of treatment to 7=very much worse since the initiation of treatment. Therefore, a lower score indicates more improvement in symptoms over time.
Outcome measures
| Measure |
Placebo
n=23 Participants
Participants received encapsulated placebo made to match active drug
|
Pimozide
n=22 Participants
Participants received pimozide flexible dosing
|
|---|---|---|
|
Clinical Global Impression of Change (CGIC)
|
-0.35 units on a scale
Standard Deviation 0.57
|
-0.15 units on a scale
Standard Deviation 4.97
|
Adverse Events
Placebo
Pimozide
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=28 participants at risk
Participants received encapsulated placebo made to match active drug
|
Pimozide
n=25 participants at risk
Participants received pimozide flexible dosing
|
|---|---|---|
|
Nervous system disorders
Severe EPS
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Renal and urinary disorders
delirium
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Gastrointestinal disorders
bleeding
|
0.00%
0/28
|
4.0%
1/25 • Number of events 1
|
|
Psychiatric disorders
psychotic symptoms
|
7.1%
2/28 • Number of events 2
|
0.00%
0/25
|
|
Cardiac disorders
bigeminy
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
Cardiac disorders
hypotension
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
|
Social circumstances
withdrew consent
|
3.6%
1/28 • Number of events 1
|
0.00%
0/25
|
Additional Information
Dr. Joseph I. Friedman
Icahn School of Medicine at Mount Sinai
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place