Trial Outcomes & Findings for Different Safety Profile of Risperidone and Paliperidone Extended-release (NCT NCT01284959)

Results Overview

SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total. Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

34 participants

Primary outcome timeframe

baseline and 2hr after third medication

Results posted on

2012-10-23

Participant Flow

Participant milestones

Participant milestones
Measure	Risperidone Drug: risperidone Groups: risperidone	Placebo drug: lactose group: placebo	Paliperidone ER Drug: Paliperidone ER Groups: Paliperidone ER
Overall Study STARTED	11	12	11
Overall Study COMPLETED	10	12	10
Overall Study NOT COMPLETED	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Risperidone Drug: risperidone Groups: risperidone	Placebo drug: lactose group: placebo	Paliperidone ER Drug: Paliperidone ER Groups: Paliperidone ER
Overall Study Withdrawal by Subject	1	0	0
Overall Study Adverse Event	0	0	1

Baseline Characteristics

Different Safety Profile of Risperidone and Paliperidone Extended-release

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Risperidone n=11 Participants Drug: risperidone Groups: risperidone	Placebo n=12 Participants drug: lactose group: placebo	Paliperidone ER n=11 Participants Drug: Paliperidone ER Groups: Paliperidone ER	Total n=34 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	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants	12 Participants n=7 Participants	11 Participants n=5 Participants	34 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age Continuous	28.40 years STANDARD_DEVIATION 2.59 • n=5 Participants	28.08 years STANDARD_DEVIATION 2.23 • n=7 Participants	30.60 years STANDARD_DEVIATION 3.27 • n=5 Participants	28.97 years STANDARD_DEVIATION 2.85 • n=4 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Region of Enrollment Korea, Republic of	11 participants n=5 Participants	12 participants n=7 Participants	11 participants n=5 Participants	34 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and 2hr after third medication

SANS(Scale for the Assessment of Negative Symptoms), NIDSS(Neuroleptic induced Deficit Syndrome Scale) In NIDSS, the average of number 1 to 5 is blunted affect, the average of number 16 to 20 is avolition, the average of number 6 to 15 is cognition, the average of all score is total. Minimum of NIDSS(avolition, blunted affect, cognition, total) is -3, maximum is +3.(subscale score and total) '+' is better outcome, '-' is worse outcome. Minimum of SANS-Global score for alogia and blunted affect is 0, Maximum of SANS-Global score for alogia and blunted affect is 5 The higher number is worse outcome. The zeros are measured and Calcuated value This outcome measure is reporting a change between baseline and 2hr after third medication.

Outcome measures

Outcome measures
Measure	Risperidone n=10 Participants Drug: risperidone Groups: risperidone	Placebo n=12 Participants drug: lactose group: placebo	Paliperidone ER n=10 Participants Drug: Paliperidone ER Groups: Paliperidone ER
Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales NIDSS-Avolition	-1.30 units on a scale Standard Deviation 1.22	-0.28 units on a scale Standard Deviation 0.64	-0.66 units on a scale Standard Deviation 0.53
Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales NIDSS-Blunted Affect	-0.70 units on a scale Standard Deviation 0.74	0.02 units on a scale Standard Deviation 0.35	-0.24 units on a scale Standard Deviation 0.64
Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales NIDSS-Cognition	-0.54 units on a scale Standard Deviation 0.53	0.02 units on a scale Standard Deviation 0.26	-0.38 units on a scale Standard Deviation 0.39
Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales NIDSS-Total	-0.77 units on a scale Standard Deviation 0.70	-0.06 units on a scale Standard Deviation 0.35	-0.42 units on a scale Standard Deviation 0.38
Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales SANS-Global score for alogia	0.67 units on a scale Standard Deviation 0.50	0 units on a scale Standard Deviation 0	0 units on a scale Standard Deviation 0
Assessment of Negative Symptoms and Neuroleptic Induced Deficit Syndromes by Objective Rating Scales SANS-Global score for blunted affect	0.67 units on a scale Standard Deviation 0.50	0 units on a scale Standard Deviation 0	0.10 units on a scale Standard Deviation 0.32

SECONDARY outcome

Timeframe: baseline and 2hr after third medication

DIEPSS(Drug-Induced Extrapyramidal Symptoms Scale), VAS(Visual analog scale);mental sedation (alert-drowsy, muzzy-clear headed, mentally slow-quick witted, attentive-dreamy), physical sedation (strong-feeble, well coordinated-clumsy, lethargic-energetic, incompetent-proficient), tranquilization (calm-excited, contented-discontented, troubled-tranquil, tense-relaxed), and other types of feelings (happy-sad, antagonistic-amicable, interested-bored, withdrawn-gregarious) Minimum of VAS(Mental sedation score,Physical sedation score,Total score) is 0, Maximum is 10. VAS-total score is average of all subscale scores. Minimum of DIEPSS is 0, Maximum is 4. The higher number is worse outcome. The score ranges are for subscale score. This outcome measure is reporting a change between baseline and 2hr after third medication.