Trial Outcomes & Findings for An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia (NCT NCT01175135)

Last Updated: 2018-05-22

Results Overview

PANSS assesses the positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. The scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). The sum of the 30 items is defined as the PANSS total score and ranges from 30 to 210; higher score indicates greater severity.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

259 participants

Primary outcome timeframe

Baseline, Week 4

Results posted on

2018-05-22

Participant Flow

Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 2 days during the placebo lead-in phase (before randomization in the study).

Participant milestones

Participant milestones
Measure	PF-02545920 5 mg Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Overall Study STARTED	74	74	37	74
Overall Study Treated	74	74	36	74
Overall Study Analyzed for Efficacy	74	73	34	73
Overall Study COMPLETED	58	52	25	60
Overall Study NOT COMPLETED	16	22	12	14

Reasons for withdrawal

Reasons for withdrawal
Measure	PF-02545920 5 mg Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Overall Study Adverse Event	2	5	3	4
Overall Study Death	1	0	0	0
Overall Study Lack of Efficacy	4	5	0	5
Overall Study Lost to Follow-up	1	2	0	0
Overall Study Protocol Violation	1	1	0	0
Overall Study Withdrawal by Subject	4	8	5	5
Overall Study Other	3	1	3	0
Overall Study Randomized But Not Treated	0	0	1	0

Baseline Characteristics

An Inpatient Study Of The Efficacy, Safety, And Tolerability Of PF-02545920 In The Treatment Of Acute Exacerbation Of Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.	Total n=258 Participants Total of all reporting groups
Age, Continuous	43.1 years STANDARD_DEVIATION 11.2 • n=5 Participants	41.7 years STANDARD_DEVIATION 10.5 • n=7 Participants	41.3 years STANDARD_DEVIATION 10.9 • n=5 Participants	41.2 years STANDARD_DEVIATION 10.9 • n=4 Participants	41.9 years STANDARD_DEVIATION 10.8 • n=21 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	14 Participants n=7 Participants	11 Participants n=5 Participants	18 Participants n=4 Participants	60 Participants n=21 Participants
Sex: Female, Male Male	57 Participants n=5 Participants	60 Participants n=7 Participants	25 Participants n=5 Participants	56 Participants n=4 Participants	198 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline, Week 4

Population: Full analysis set (FAS) included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=73 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=34 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=73 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 Change at Week 4	-15.3 units on a scale Standard Deviation 15.56	-13.8 units on a scale Standard Deviation 17.93	-17.9 units on a scale Standard Deviation 10.99	-12.6 units on a scale Standard Deviation 15.29
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 4 Baseline	98.1 units on a scale Standard Deviation 11.81	97.7 units on a scale Standard Deviation 11.14	97.4 units on a scale Standard Deviation 15.05	97.2 units on a scale Standard Deviation 14.92

PRIMARY outcome

Timeframe: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Participants were assessed for presence of symptoms for any one of the following: dystonia, oromandibular dystonia, and oculogyric crisis.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Proportion of Participants With Dystonia Adverse Events	0.01 proportion of participants	0.08 proportion of participants	0.00 proportion of participants	0.04 proportion of participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.

PANSS - positive, negative, and general subscales assesses positive, negative and general psychopathological symptoms associated with schizophrenia respectively. Seven (7) items each make up the positive scale (for example; delusions, conceptual disorganization, and hallucinatory behavior) and negative scale (for example; blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal) and 16 items make up the general scale (for example; somatic concern, anxiety, guilt feelings, mannerisms and posturing, motor retardation, uncooperativeness, disorientation, poor impulse control, pre-occupation). Each item is rated on a 7-point Likert scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total scores range for positive as well as negative subscale is 7 to 49 and for general subscale is 16 to 112; higher subscale score indicates greater severity.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=73 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=34 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=73 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 Baseline: Positive Score	26.9 units on a scale Standard Deviation 4.00	26.1 units on a scale Standard Deviation 3.89	26.6 units on a scale Standard Deviation 4.74	26.8 units on a scale Standard Deviation 4.16
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 Baseline: Negative Score	23.4 units on a scale Standard Deviation 4.15	23.4 units on a scale Standard Deviation 4.32	24.0 units on a scale Standard Deviation 5.18	23.2 units on a scale Standard Deviation 5.12
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 Baseline: General Score	47.9 units on a scale Standard Deviation 6.67	48.2 units on a scale Standard Deviation 6.43	46.8 units on a scale Standard Deviation 8.25	47.2 units on a scale Standard Deviation 7.73
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 Change at Week 4: Positive Score	-5.0 units on a scale Standard Deviation 5.26	-4.5 units on a scale Standard Deviation 5.51	-6.7 units on a scale Standard Deviation 3.84	-4.5 units on a scale Standard Deviation 4.68
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 Change at Week 4: Negative Score	-2.7 units on a scale Standard Deviation 4.62	-2.2 units on a scale Standard Deviation 5.09	-2.7 units on a scale Standard Deviation 4.03	-1.5 units on a scale Standard Deviation 3.78
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Positive, Negative, and General Subscales Score at Week 4 Change at Week 4: General Score	-7.5 units on a scale Standard Deviation 7.75	-7.1 units on a scale Standard Deviation 8.80	-8.6 units on a scale Standard Deviation 5.85	-6.6 units on a scale Standard Deviation 8.20

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.

CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state. Clinician responded to a question "Considering your total clinical experience with this particular population, how mentally ill is your patient at this time?" on the following scores: 1 (normal - not ill at all), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most severely ill participants). Higher score = more affected.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=73 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=34 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=73 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 Change at Week 4	-0.7 units on a scale Standard Deviation 0.87	-0.7 units on a scale Standard Deviation 1.06	-0.8 units on a scale Standard Deviation 0.78	-0.6 units on a scale Standard Deviation 0.92
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 4 Baseline	5.0 units on a scale Standard Deviation 0.56	5.0 units on a scale Standard Deviation 0.49	4.9 units on a scale Standard Deviation 0.67	5.0 units on a scale Standard Deviation 0.58

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.

PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). PANSS Marder positive symptoms subscale consists of 8 items with total score equal to sum of 8 items ranging from 8-56; Marder negative symptoms subscale and Marder disorganized thoughts (Dis. Thought) subscale, each consists of 7 items with total score equal to sum of 7 items each, ranging from 7-49, Marder uncontrolled hostility/excitement (Uncon. Hos/Exc) subscale and Marder anxiety/depression (Anx/Dep) subscale, each consists of 4 items with total score equal to sum of 4 items each ranging from 4-28. Higher subscale score indicates greater severity.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=73 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=34 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=73 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Baseline: Positive score	30.9 units on a scale Standard Deviation 4.51	30.6 units on a scale Standard Deviation 4.12	30.3 units on a scale Standard Deviation 5.45	31.0 units on a scale Standard Deviation 4.68
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Baseline: Negative Score	23.0 units on a scale Standard Deviation 4.43	23.3 units on a scale Standard Deviation 4.99	22.9 units on a scale Standard Deviation 5.04	23.0 units on a scale Standard Deviation 5.06
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Baseline: Dis. Thought Score	20.4 units on a scale Standard Deviation 5.13	21.0 units on a scale Standard Deviation 4.37	21.3 units on a scale Standard Deviation 5.49	20.3 units on a scale Standard Deviation 5.70
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Baseline: Uncon. Hos/Exc Score	10.4 units on a scale Standard Deviation 2.92	9.8 units on a scale Standard Deviation 2.98	10.6 units on a scale Standard Deviation 3.97	10.0 units on a scale Standard Deviation 3.44
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Baseline: Anx/Dep Score	13.5 units on a scale Standard Deviation 2.81	13.0 units on a scale Standard Deviation 3.16	12.4 units on a scale Standard Deviation 3.17	12.9 units on a scale Standard Deviation 2.56
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Change at Week 4: Positive score	-5.5 units on a scale Standard Deviation 5.34	-5.0 units on a scale Standard Deviation 5.56	-6.2 units on a scale Standard Deviation 4.53	-4.6 units on a scale Standard Deviation 5.00
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Change at Week 4: Negative Score	-3.0 units on a scale Standard Deviation 4.99	-2.9 units on a scale Standard Deviation 5.69	-2.5 units on a scale Standard Deviation 4.44	-2.3 units on a scale Standard Deviation 4.91
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Change at Week 4:Dis. Thought Score	-2.5 units on a scale Standard Deviation 3.47	-2.3 units on a scale Standard Deviation 4.39	-3.0 units on a scale Standard Deviation 3.06	-1.9 units on a scale Standard Deviation 3.05
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Change at Week 4:Uncon.Hos/ExcScore	-1.2 units on a scale Standard Deviation 3.31	-0.9 units on a scale Standard Deviation 3.12	-2.4 units on a scale Standard Deviation 2.28	-1.0 units on a scale Standard Deviation 2.95
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Marder Factors Score at Week 4 Change at Week 4: Anx/DepScore	-2.9 units on a scale Standard Deviation 3.72	-2.6 units on a scale Standard Deviation 3.85	-3.8 units on a scale Standard Deviation 3.31	-2.9 units on a scale Standard Deviation 3.22

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.

PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. PANSS derived BPRS is an 18-item clinician rated scale which assesses symptoms such as hostility, suspiciousness, hallucinations, grandiosity, and a number of other psychiatric symptoms. Items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. BPRS core score consists of 4 items (Conceptual disorganization, Hallucinatory behavior, Suspiciousness/persecution, Unusual thought content) with total score equal to sum of the 4 items, ranging from 4 to 28, with higher score indicating greater severity.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=73 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=34 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=73 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 Baseline	17.4 units on a scale Standard Deviation 2.74	17.3 units on a scale Standard Deviation 2.32	17.2 units on a scale Standard Deviation 2.77	17.3 units on a scale Standard Deviation 2.39
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) - Derived Brief Psychiatric Rating Scale (BPRS) Core Score at Week 4 Change at Week 4	-3.7 units on a scale Standard Deviation 3.39	-3.4 units on a scale Standard Deviation 3.75	-4.7 units on a scale Standard Deviation 2.99	-3.2 units on a scale Standard Deviation 3.12

SECONDARY outcome

Timeframe: Week 4

Population: FAS included all participants who received at least 1 dose of randomized study medication, and had a baseline and at least 1 post-baseline measurement.

CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Clinician responded to a question: "Compared to your subject's condition at the beginning of treatment, how much has your subject changed?" Compared to Baseline (Day 1), improvement was defined as score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=63 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=58 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=26 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=63 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Clinical Global Impression - Improvement (CGI-I) Score	3.1 units on a scale Standard Deviation 0.98	3.3 units on a scale Standard Deviation 1.35	2.7 units on a scale Standard Deviation 0.89	3.2 units on a scale Standard Deviation 1.05

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

GAF is a 100-point, clinician rated single item scale that rates the severity of illness-related impairment in psychological, social and occupational functioning of participants on a hypothetical continuum of mental illness to mental health. The scale values range from 1 to 100 with lower score indicating greater severity of illness and is divided into 10 equal intervals (descriptors): from 1-10 (persistent danger of hurting self - serious suicidal acting with clear expectations of death) to 91-100 (superior functioning - no symptoms). Each descriptor has a nine-point range to allow for some variability of severity within the descriptor.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=73 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=71 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=34 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=72 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 Baseline	38.4 units on a scale Standard Deviation 8.31	38.5 units on a scale Standard Deviation 7.82	38.7 units on a scale Standard Deviation 10.58	38.2 units on a scale Standard Deviation 8.78
Change From Baseline in Global Assessment of Functioning (GAF) Score at Week 4 Change at Week 4	6.3 units on a scale Standard Deviation 9.08	6.9 units on a scale Standard Deviation 8.92	7.7 units on a scale Standard Deviation 8.45	6.3 units on a scale Standard Deviation 8.14

SECONDARY outcome

Timeframe: Week 4

Population: FAS. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

TSQM assesses the participant's level of satisfaction with study medication. It consists of a 14-item questionnaire which comprises of 3 specific scales (effectiveness, side effects, convenience) and 1 global satisfaction scale. Effectiveness, convenience and global satisfaction scale are rated on a 7-point scale (0= Extremely Dissatisfied, 1= Very Dissatisfied, 2= Dissatisfied, 3= Somewhat Satisfied, 4= Satisfied, 5= Very Satisfied, 6= Extremely Satisfied) and side effects are rated on a 5-point scale (0= Extremely Dissatisfied, 1=Very Dissatisfied, 2= Somewhat Dissatisfied, 3= Slightly Dissatisfied, 4= Not at all Dissatisfied). Scale scores are transformed into scores ranging from 0 to 100, with a higher score indicating more satisfaction.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=71 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=70 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=32 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=69 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Treatment Satisfaction Questionnaire for Medication (TSQM) Score Effectiveness	53.68 units on a scale Standard Deviation 24.84	51.90 units on a scale Standard Deviation 24.28	63.37 units on a scale Standard Deviation 24.07	53.70 units on a scale Standard Deviation 19.68
Treatment Satisfaction Questionnaire for Medication (TSQM) Score Side-Effects	86.43 units on a scale Standard Deviation 24.45	79.20 units on a scale Standard Deviation 28.67	87.30 units on a scale Standard Deviation 22.02	87.41 units on a scale Standard Deviation 24.00
Treatment Satisfaction Questionnaire for Medication (TSQM) Score Convenience	70.46 units on a scale Standard Deviation 17.46	68.37 units on a scale Standard Deviation 18.49	75.69 units on a scale Standard Deviation 15.44	66.83 units on a scale Standard Deviation 15.12
Treatment Satisfaction Questionnaire for Medication (TSQM) Score Global Satisfaction	56.84 units on a scale Standard Deviation 28.30	51.02 units on a scale Standard Deviation 27.79	66.07 units on a scale Standard Deviation 23.38	49.48 units on a scale Standard Deviation 24.69

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Safety analysis set included all participants who received at least 1 dose of study medication. Here 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=72 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Body Weight at Week 4 Baseline	86.1 kilogram (kg) Standard Deviation 15.06	87.5 kilogram (kg) Standard Deviation 14.46	83.9 kilogram (kg) Standard Deviation 16.99	84.3 kilogram (kg) Standard Deviation 19.31
Change From Baseline in Body Weight at Week 4 Change at Week 4	0.18 kilogram (kg) Standard Deviation 2.23	-1.23 kilogram (kg) Standard Deviation 3.18	2.69 kilogram (kg) Standard Deviation 3.00	1.04 kilogram (kg) Standard Deviation 2.61

SECONDARY outcome

Timeframe: Baseline, Week 4

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=72 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=72 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Abdominal Girth at Week 4 Change at Week 4	0.71 centimeter (cm) Standard Deviation 5.07	0.70 centimeter (cm) Standard Deviation 5.73	3.33 centimeter (cm) Standard Deviation 4.54	0.74 centimeter (cm) Standard Deviation 4.29
Change From Baseline in Abdominal Girth at Week 4 Baseline	96.5 centimeter (cm) Standard Deviation 12.33	97.2 centimeter (cm) Standard Deviation 13.49	95.6 centimeter (cm) Standard Deviation 13.58	93.5 centimeter (cm) Standard Deviation 16.05

SECONDARY outcome

Timeframe: Baseline up to end of study (7 to 10 days after administration of last dose of study medication)

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Clinically significant findings based on investigator's discretion were assessed in vital sign parameters (including pulse rate, blood pressure and body temperature) and ECG parameters (including respiratory rate, heart rate, PR interval, QRS interval, QT interval, QT corrected using Bazett's correction \[QTcB\] interval, and QT corrected using Fridericia's correction \[QTcF\]).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Number of Participants With Clinically Significant Findings in Vital Signs and Electrocardiogram (ECG)	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Screening, Week 4

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Clinically significant findings in physical examinations based on investigator's discretion were assessed. Screening was the 7 day time (from Day -8 to Day -2) before dosing on Day 1. Number of participants with clinically significant changes in physical examinations compared to screening was assessed.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Number of Participants With Clinically Significant Changes in Physical Examinations	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Screening up to end of study (7 to 10 days after administration of last dose of study medication)

Criteria for abnormality:hematology: hemoglobin, hematocrit, red blood cell count: less than(\<) 0.8\*lower limit of normal (LLN); mean corpuscular volume; mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration: \<0.9\*LLN,\>1.1\*upper limit of normal (ULN); platelets: \<0.5\*LLN,\>1.75\*ULN, white blood cell count: \<0.6\*LLN, \>1.5\*ULN; lymphocytes, total neutrophils: \<0.8\*LLN, \>1.2\*ULN; eosinophils, basophils, monocytes: \>1.2\*ULN; coagulation: activated partial thromboplastin time, prothrombin, prothrombin international ratio: \>1.1\*ULN; liver function: bilirubin: \>1.5\*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase: \>3.0\*ULN; protein, albumin: \<0.8\*LLN\>\</0\>1.2\*ULN; renal function:blood urea nitrogen,creatinine: \>1.3\*ULN; uric acid: \>1.2\*ULN; electrolytes: sodium, potassium, chloride, calcium, bicarbonate: \<0.9\*LLN,\>1.1\*ULN; urinalysis: pH\<4.5, \>8; glucose, protein, blood, ketones, urobilinogen, bilirubin, nitrite; Other(glucose: \<0.6\*LLN,\>1.5\*ULN)

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=35 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Number of Participants With Laboratory Test Abnormalities	55 participants	58 participants	34 participants	56 participants

SECONDARY outcome

Timeframe: Day 1 up to Week 4

Pre-defined criteria was established for WBC Count (less than 0.6 times the lower limit of normal) and absolute neutrophil count (less than 0.8 times the lower limit of normal) to define the values that would be identified as abnormal.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=35 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) WBC	0 participants	0 participants	0 participants	0 participants
Number of Participants With Abnormal White Blood Cell (WBC) Count and Absolute Neutrophil Count (ANC) ANC	6 participants	6 participants	0 participants	8 participants

SECONDARY outcome

Timeframe: Day 1 up to Week 4

Clinically significant findings based on investigator's discretion were assessed in laboratory parameters (including fasting insulin, high-density lipoprotein \[HDL\], low-density lipoprotein \[LDL\], Cholesterol, Triglycerides, glycosylated hemoglobin type A1c \[HbA1c\] and Prolactin).

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=35 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Number of Participants With Clinically Significant Laboratory Test Abnormalities for Fasting Insulin, High Density Lipoprotein (HDL), Low Density Lipoprotein (LDL), Cholesterol, Triglycerides, Hemoglobin Type A1c (HbA1c) and Prolactin	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

ESRS-A is a clinician rated scale consisting of 24 items to assess severity of extra-pyramidal symptoms for following parameters: parkinsonism (10 items), dystonia (6 items), dyskinesia (6 items) and akathisia (2 items). Each item is scored on a 6-point Likert scale (0=absent, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=extreme). Total score for a parameter is average of individual item scores included under the parameter, ranging from 0 to 5, with higher score = more affected.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Baseline: Dystonia	0.095 units on a scale Standard Deviation 0.5278	0.000 units on a scale Standard Deviation 0.0000	0.000 units on a scale Standard Deviation 0.0000	0.027 units on a scale Standard Deviation 0.1633
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Baseline: Dyskinesia	0.122 units on a scale Standard Deviation 0.4038	0.095 units on a scale Standard Deviation 0.4432	0.194 units on a scale Standard Deviation 0.5767	0.135 units on a scale Standard Deviation 0.5054
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Baseline: Akathisia	0.162 units on a scale Standard Deviation 0.5496	0.068 units on a scale Standard Deviation 0.4778	0.111 units on a scale Standard Deviation 0.6667	0.243 units on a scale Standard Deviation 0.7551
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Change at Week 4: Parkinsonism	0.143 units on a scale Standard Deviation 0.8397	0.086 units on a scale Standard Deviation 1.3414	-0.038 units on a scale Standard Deviation 0.9157	-0.190 units on a scale Standard Deviation 1.4126
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Change at Week 4: Dystonia	0.000 units on a scale Standard Deviation 0.4016	0.207 units on a scale Standard Deviation 1.1044	0.000 units on a scale Standard Deviation 0.0000	0.032 units on a scale Standard Deviation 0.2520
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Change at Week 4: Dyskinesia	0.016 units on a scale Standard Deviation 0.4916	0.207 units on a scale Standard Deviation 1.0884	0.038 units on a scale Standard Deviation 0.4455	-0.032 units on a scale Standard Deviation 0.3578
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Change at Week 4: Akathisia	0.032 units on a scale Standard Deviation 0.6713	0.328 units on a scale Standard Deviation 1.3297	0.154 units on a scale Standard Deviation 1.2866	-0.095 units on a scale Standard Deviation 0.9283
Change From Baseline in Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A) Parameter Scores at Week 4 Baseline: Parkinsonism	0.257 units on a scale Standard Deviation 1.0476	0.500 units on a scale Standard Deviation 1.5283	0.194 units on a scale Standard Deviation 0.6242	0.473 units on a scale Standard Deviation 1.5809

SECONDARY outcome

Timeframe: Baseline, Week 4

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

MDBS-D score reflects the numbers and durations of movement disorder adverse events for dystonia, the severity of the events, required treatment, and the total number of days the participant received study treatment. MDBS-D score = (S \* D \* C)/TTD; where S= Movement Disorder Severity Score for Dystonia (possible values: 1 \[mild\]; 2 \[moderate\]; 3 \[severe\]), D=adverse event duration (in days), C=concomitant medication factor (C=1.5 if an anti-cholinergic or beta blocker is used for the treatment of a movement disorder; C=1 if no concomitant medication is used), TTD=total treatment days for the participant. Value for MDBS score may range from zero to infinity. A higher MDBS-D score indicates a greater movement disorder adverse event liability compared to baseline.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Change From Baseline in Movement Disorder Burden Score for Dystonia (MDBS-D) at Week 4	0.0019 units on a scale Standard Deviation 0.01648	0.0163 units on a scale Standard Deviation 0.08087	0.0000 units on a scale Standard Deviation 0.00000	0.0126 units on a scale Standard Deviation 0.10349

SECONDARY outcome

Timeframe: Baseline, Week 1, 2, 3, 4, Follow-up (FU) (7 to 10 days after administration of last dose of study medication)

Population: Safety analysis set included all participants who received at least 1 dose of study medication.

Data relevant to the assessment of suicidality is mapped to the Columbia Classification Algorithm of Suicide Assessment (C-CASA) event codes. C-SSRS assesses whether participant experiences following: suicide attempt (Event code 2) (Response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior (Event code 3) ("Yes" on "aborted attempt", "interrupted attempt", "preparatory acts or behavior"), suicidal ideation (Event code 4) ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act/some intent to act without specific plan or with specific plan and intent), self-injurious behavior, no suicidal intent (Event code 7) ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior"). Number of participants with "Yes" response for above mentioned categories are assessed. Baseline is defined as the Week 0 measurement.

Outcome measures

Outcome measures
Measure	PF-02545920 5 mg n=74 Participants Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 Participants Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 Participants Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 Participants Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline: Event code 2	1 participants	1 participants	0 participants	1 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline: Event code 3	1 participants	0 participants	0 participants	2 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline: Event code 4	1 participants	4 participants	1 participants	3 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Baseline: Event code 7	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 1: Event code 2	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 1: Event code 3	0 participants	1 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 1: Event code 4	0 participants	4 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 1: Event code 7	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 2: Event code 2	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 2: Event code 3	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 2: Event code 4	1 participants	3 participants	0 participants	1 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 2: Event code 7	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 3: Event code 2	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 3: Event code 3	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 3: Event code 4	0 participants	2 participants	0 participants	1 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 3: Event code 7	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 4: Event code 2	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 4: Event code 3	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 4: Event code 4	3 participants	3 participants	1 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) Week 4: Event code 7	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) FU: Event code 2	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) FU: Event code 3	0 participants	0 participants	0 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) FU: Event code 4	1 participants	0 participants	1 participants	0 participants
Number of Participants With Response to Columbia-Suicide Severity Rating Scale (C-SSRS) FU: Event code 7	0 participants	0 participants	0 participants	0 participants

Adverse Events

PF-02545920 5 mg

Serious events: 3 serious events

Other events: 53 other events

Deaths: 0 deaths

PF-02545920 15 mg

Serious events: 6 serious events

Other events: 47 other events

Deaths: 0 deaths

Risperidone 3 mg

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 51 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	PF-02545920 5 mg n=74 participants at risk Participants received PF-02545920 5 milligram (mg) tablet, orally every 12 hours for 28 days.	PF-02545920 15 mg n=74 participants at risk Participants received PF-02545920 tablet, dose was titrated with a starting dose of 5 mg up to 15 mg, orally every 12 hours for 28 days.	Risperidone 3 mg n=36 participants at risk Participants received risperidone tablet-in-capsule, dose was titrated with a starting dose of 1 mg up to 3 mg, orally every 12 hours for 28 days.	Placebo n=74 participants at risk Participants received placebo-matched to PF-02545920 tablet and placebo-matched to risperidone tablet-in-capsule orally every 12 hours for 28 days.
Cardiac disorders Acute myocardial infarction	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Cardiac disorders Myocardial rupture	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
General disorders Sudden cardiac death	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Homicidal ideation	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 1/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Psychotic disorder	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.7% 2/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Schizophrenia	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	4.1% 3/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 1/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Psychiatric disorders Suicidal ideation	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	1.4% 1/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.8% 1/36 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/74 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER