Trial · NCT00563706

Study Evaluating Vabicaserin in Subjects With Schizophrenia

NCT00563706, Phase 2, Completed, Pfizer; results first posted 2014-03-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study Evaluating Vabicaserin in Subjects With Schizophrenia. Trials, record NCT00563706. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00563706

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study Evaluating Vabicaserin in Subjects With Schizophrenia
NCT number: NCT00563706
Status: Completed
Phases: Phase 2
Enrollment: 199 participants, actual
Lead sponsor: Pfizer
Conditions: Schizophrenia
Interventions: vabicaserin, risperidone, placebo
First posted: 2007-11-26
Last updated: 2014-03-20
Results first posted: 2014-03-20
Limitations and caveats: Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Baseline	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.
Primary	Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28	Baseline, Day 28	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.
Secondary	Positive and Negative Symptom Scale (PANSS) Positive Subscale Score	Baseline, Day 7, 14, 21, 28	PANSS positive subscale assesses positive symptoms associated with schizophrenia. The positive subscale consists of 7 items (delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total positive subscale scores range from 7 to 49; higher score indicates greater severity.
Secondary	Positive and Negative Symptom Scale (PANSS) Negative Subscale Score	Baseline, Day 7, 14, 21, 28	PANSS negative subscale assesses negative symptoms associated with schizophrenia. The negative subscale consists of 7 items (blunted affect, emotional withdrawal, poor rapport, passive/apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total negative subscale scores range from 7 to 49; higher score indicates greater severity.
Secondary	Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score	Baseline, Day 7, 14, 21, 28	General psychopathology subscale assesses general psychopathology symptoms associated with schizophrenia. The general psychopathology subscale consists of 16 items (somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total general psychopathology subscale scores range from 16 to 112; higher score indicates greater severity.
Secondary	Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score	Baseline, Day 7, 14, 21, 28	Cognition cluster subscale assesses cognitive symptoms associated with schizophrenia. The cognition cluster subscale score is a sum of 5 items from positive, negative and general psychopathology subscales (conceptual disorganization, difficulty in abstract thinking, poor attention, lack of judgment and insight, and preoccupation). Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Total cognition cluster subscale scores range from 5 to 35; higher score indicates greater severity.
Secondary	Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score	Baseline, Day 7, 14, 21, 28	Responders were defined as 20 percent (%) responders and 50 % responders. A 20% responder was a participant whose PANSS total score was decreased by at least 20% from baseline to the week of assessment. A 50% responder was a participant whose PANSS total score was decreased by at least 50 % from baseline to the week of assessment. PANSS total score 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.
Secondary	Clinical Global Impression - Severity (CGI-S) Score	Baseline, Day 7, 14, 21, 28	CGI-S: 7-point clinician rated scale to assess severity of participant's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients).
Secondary	Clinical Global Impression - Improvement (CGI-I) Score	Day 7, 14, 21, 28	CGI-I: 7-point clinician rated scale to assess global improvement in the participant's clinical state compared to baseline; range: 1 (very much improved) to 7 (very much worse).
Secondary	Calgary Depression Scale for Schizophrenia (CDSS) Score	Baseline, Day 7, 14, 21, 28	CDSS: 9-item clinician rated scale, validated for rating the severity of depressive symptoms in participants with schizophrenia. Each item is rated on a 4-point scale ranging from 0 (absent) to 3 (severe). CDSS total score is the sum of each item scores and ranges from 0 to 27; higher score indicates more severity of symptoms.

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Baseline	Modified intent-to-treat (mITT) population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score.	units on a scale	MEAN
PRIMARY	Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28	Baseline, Day 28	mITT population included all randomized participants who received at least 1 dose of double-blind test article, had baseline and at least 1 on-therapy PANSS total score. Here N (number of participants analyzed) signifies those participants who were evaluable for this measure.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Positive and Negative Symptom Scale (PANSS) Positive Subscale Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Positive and Negative Symptom Scale (PANSS) Negative Subscale Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Clinical Global Impression - Severity (CGI-S) Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Clinical Global Impression - Improvement (CGI-I) Score	Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.
SECONDARY	Calgary Depression Scale for Schizophrenia (CDSS) Score	Baseline, Day 7, 14, 21, 28	Because of the failure of all vabicaserin doses to meet the primary efficacy objective, the study was terminated prematurely and planned analyses of secondary efficacy endpoints were not performed.

Source ClinicalTrials.gov

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Placebo	94.74	Standard Deviation 11.18	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 50 mg	94.24	Standard Deviation 8.42	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 100 mg	96.88	Standard Deviation 14.54	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 150 mg	101.33	Standard Deviation 12.97	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 200 mg	93.06	Standard Deviation 8.84	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 300 mg	94.39	Standard Deviation 8.73	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 400 mg	92.83	Standard Deviation 10.25	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Vabicaserin 600 mg	95.54	Standard Deviation 12.46	units on a scale
Positive and Negative Symptom Scale (PANSS) Total Score at Baseline	Risperidone	91.43	Standard Deviation 10.83	units on a scale
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28	Placebo	-17.03	Standard Error 3.59	units on a scale

1 to 10 of 18Source ClinicalTrials.gov

See all 18 results by group

Participant flow54

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
DB Treatment Period (Day 1 up to Day 28)	STARTED	Placebo	37
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 50 mg	18
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 100 mg	8
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 150 mg	19
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 200 mg	16
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 300 mg	19
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 400 mg	12
DB Treatment Period (Day 1 up to Day 28)	STARTED	Vabicaserin 600 mg	30
DB Treatment Period (Day 1 up to Day 28)	STARTED	Risperidone	43
DB Treatment Period (Day 1 up to Day 28)	COMPLETED	Placebo	20

1 to 10 of 54Source ClinicalTrials.gov

See all 54 participant flow

Adverse events1,026

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Neutropenia	Blood and lymphatic system disorders	Placebo	0	37
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 50 mg	0	18
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 100 mg	0	8
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 150 mg	0	19
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 200 mg	0	16
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 300 mg	1	19
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 400 mg	0	12
other	Neutropenia	Blood and lymphatic system disorders	Vabicaserin 600 mg	0	30
other	Neutropenia	Blood and lymphatic system disorders	Risperidone	0	43
other	Tachycardia	Cardiac disorders	Placebo	0	37

1 to 10 of 1,026Source ClinicalTrials.gov

See all 1,026 adverse events

Adverse event totals27

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Vabicaserin 50 mg
Total, all-cause mortality	Vabicaserin 100 mg
Total, all-cause mortality	Vabicaserin 150 mg
Total, all-cause mortality	Vabicaserin 200 mg
Total, all-cause mortality	Vabicaserin 300 mg
Total, all-cause mortality	Vabicaserin 400 mg
Total, all-cause mortality	Vabicaserin 600 mg
Total, all-cause mortality	Risperidone
Total, other adverse events	Placebo	28	37

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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