Trial Outcomes & Findings for A Positron-Emission-Tomography (PET) Study to Measure the Blockade of Dopamine Receptors (D2) in Specific Areas of the Brain in Relation to the Plasma Concentrations of Paliperidone Extended Release (ER) and Oral Risperidone in Schizophrenia Patients and Healthy Controls (NCT NCT00934635)
NCT ID: NCT00934635
Last Updated: 2014-02-11
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
Visit 3 (on day 3)
Results posted on
2014-02-11
Participant Flow
Participant milestones
| Measure |
Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours
Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours
Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
|
Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Control
PET Scan Control
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Positron-Emission-Tomography (PET) Study to Measure the Blockade of Dopamine Receptors (D2) in Specific Areas of the Brain in Relation to the Plasma Concentrations of Paliperidone Extended Release (ER) and Oral Risperidone in Schizophrenia Patients and Healthy Controls
Baseline characteristics by cohort
| Measure |
Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours
Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours
n=1 Participants
Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
|
Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Control
n=1 Participants
PET Scan Control
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
1 participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
—
|
0 participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 participants
n=42 Participants
|
0 participants
n=42 Participants
|
|
Age, Customized
27 years of age
|
—
|
1 years
NA • n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 years
NA • n=42 Participants
|
1 years
n=42 Participants
|
|
Age, Customized
19 years of age
|
—
|
0 years
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
1 years
n=42 Participants
|
1 years
n=42 Participants
|
|
Gender
Female
|
—
|
0 participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
1 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Gender
Male
|
—
|
1 participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
0 participants
n=42 Participants
|
1 participants
n=42 Participants
|
|
Region of Enrollment
Germany
|
—
|
1 participants
n=7 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
1 participants
n=42 Participants
|
2 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Visit 3 (on day 3)Population: PET imaging data were not submitted for further analysis. D2-receptor occupancies could not be calculated due to the low number of subjects in the healthy control group.
Outcome measures
| Measure |
Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours
Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours
n=1 Participants
Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
|
Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Control
n=1 Participants
PET Scan Control
|
|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Paliperidone or Risperidone Dopamine D2 Receptor Occupancies
|
—
|
0 percentage
|
—
|
—
|
—
|
—
|
—
|
—
|
0 percentage
|
SECONDARY outcome
Timeframe: Measurement of plasma concentration at Visit 3 (day 3)No measures available due to early termination of trial
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Analysis of PET scans at Visit 3 (day 3)No measures available due to early termination of trial
Outcome measures
Outcome data not reported
Adverse Events
Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours
Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours
n=1 participants at risk
Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours
Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
|
Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
|
Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours
Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours
Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
|
Control
n=1 participants at risk
PET Scan Control
|
|---|---|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Exacerbation of schizophrenic symptoms
|
—
0/0
|
100.0%
1/1 • Number of events 1
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
—
0/0
|
0.00%
0/1
|
Other adverse events
Adverse event data not reported
Additional Information
Medical Development Manager; Medical and Scientific Affairs
Janssen Cilag
Phone: 0049-2137-955-1240
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of study data will be coordinated by the Sponsor, but written by the Investigator. The Medical Institution will not be entitled to publish any data unless the Sponsor has received the manuscript within 3 months after the Clinical Study Report for review (within 30 days) to ensure that the publication does not reveal secret information. If the Sponsor suggests changes, these changes must be incorporated unless they compromise the scientific nature of the publication.
- Publication restrictions are in place
Restriction type: OTHER