SchizophreniaPhase 2NCT00563706

Study Evaluating Vabicaserin in Subjects With Schizophrenia

A Phase 2 study testing vabicaserin and risperidone in people with Schizophrenia, run by Pfizer at 33 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia. Read more about this study

Who is it for?: Ages 18 to 65 years, men only
Conditions the study is for: Schizophrenia
What is being tested?: vabicaserin and risperidone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 199 participants
Where: 33 sitesin 2 countries
Study dates: Dec 2007to Jun 2008
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

Generally healthy, men and women, aged 18 to 65.
Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Who cannot join

Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.

Trial locations and contacts

33 sites in 2 countries.

Country

City, postcode or hospital

33 sites in 2 countries

United States32 sites

Pfizer Investigational Site
Arlington, Virginia, 22201
Pfizer Investigational Site
Austin, Texas, 78754
Pfizer Investigational Site
Austin, Texas, 78756
Pfizer Investigational Site
Aventura, Florida, 33180
Pfizer Investigational Site
Baltimore, Maryland, 21202
Pfizer Investigational Site
Bellaire, Texas, 77008
Pfizer Investigational Site
Butner, North Carolina, 27509
Pfizer Investigational Site
Cedarhurst, New York, 11516
Pfizer Investigational Site
Cerritos, California, 90703
Pfizer Investigational Site
DeSoto, Texas, 75115
Pfizer Investigational Site
Escondido, California, 92025
Pfizer Investigational Site
Garden Grove, California, 92845
Pfizer Investigational Site
Glendale, California, 91206
Pfizer Investigational Site
Hamilton, New Jersey, 08619
Pfizer Investigational Site
Hoffman Estates, Illinois, 60169
Pfizer Investigational Site
Holliswood, New York, 11423
Pfizer Investigational Site
Hollywood, Florida, 33021
Pfizer Investigational Site
Houston, Texas, 77008
Pfizer Investigational Site
Indianapolis, Indiana, 46222
Pfizer Investigational Site
Kissimmee, Florida, 34741
Pfizer Investigational Site
Lake Charles, Louisiana, 70601
Pfizer Investigational Site
Little Rock, Arkansas, 72201
Pfizer Investigational Site
New York, New York, 10032
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19131
Pfizer Investigational Site
Portsmouth, Virginia, 23707
Pfizer Investigational Site
Rockville, Maryland, 20850
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92123
Pfizer Investigational Site
Torrance, California, 90502
Pfizer Investigational Site
Washington D.C., District of Columbia, 20016
Pfizer Investigational Site
Willingboro, New Jersey, 08046

Other trials in United States

Canada1 site

Pfizer Investigational Site
Kingston, Ontario, K7L 4X3

Other trials in Canada

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.

Conditions: Schizophrenia
Being tested: vabicaserin, risperidone, placebo
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

vabicaserinDrug
This study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study
risperidoneDrug
placeboOther

Study groups in NCT00563706
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: vabicaserin
2	Active comparator	4mg/day Receives: Drug: risperidone
3	Placebo comparator	matching placebo Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Positive and Negative Symptom Scale (PANSS) Total Score at 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.
Measured: Baseline
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at 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.
Measured: Baseline, Day 28

Secondary outcomes (8)

Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
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.
Measured: Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
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.
Measured: Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
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.
Measured: Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
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.
Measured: Baseline, Day 7, 14, 21, 28
Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
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.
Measured: Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Severity (CGI-S) Score
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).
Measured: Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Improvement (CGI-I) Score
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).
Measured: Day 7, 14, 21, 28
Calgary Depression Scale for Schizophrenia (CDSS) Score
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.
Measured: Baseline, Day 7, 14, 21, 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2007Jun 2008

First posted26 Nov 2007 (estimated)
Study startDec 2007
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 199 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00563706
Sponsor's protocol ID: 3153A1-2203
Other IDs: B1911032
Status last verified: Feb 2014
First submitted: 21 Nov 2007
Last updated: 20 Mar 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled, Risperidone-Referenced, Parallel-Group, Adaptive-Design Study of the Efficacy, Safety, and Tolerability of Vabicaserin (SCA-136) in Subjects With Acute Exacerbations of Schizophrenia
ClinicalTrials.gov ID: NCT00563706
Acronym / sponsor ID: 3153A1-2203
Conditions: Schizophrenia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 199 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Dec 2007
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 26 Nov 2007 (estimated)
Results: Posted 20 Mar 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The primary purpose of this protocol is to establish the efficacy, safety, and tolerability of vabicaserin (SCA-136) using a once a day capsule in subjects with acute exacerbations of schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: vabicaserin
2	Active comparator	Drug: risperidone4mg/day
3	Placebo comparator	Other: placebomatching placebo

Who may qualify

Ages: 18 to 65 years
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Generally healthy, men and women, aged 18 to 65.
Hospitalization because of an acute exacerbation of schizophrenia with a diagnosis of schizophrenia established greater than 1 year.
Ability to remain hospitalized for the duration of the screening period and for 4 weeks of double-blind treatment.

Key exclusion criteria (3 listed)

Current Axis I primary psychiatric diagnosis other than schizophrenia (DSM-IV-TR criteria).
Current diagnosis or history of substance abuse or dependence (DSM-IV-TR criteria), including alcohol (except for nicotine), within 3 months before baseline (day -1).
Subjects taking high or chronic doses of benzodiazepine at the screening evaluation who, in the investigator's judgment, would be likely to have severe withdrawal symptoms upon discontinuation.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
vabicaserinThis study will utilize a randomized, double-blind, placebo-controlled, comparator-referenced, multicenter, parallel-group adaptive design with placebo, risperidone (4 mg/day), and up to 7 treatment arms of vabicaserin (50, 100, 150, 200, 300, 400 and 600 mg/day) over the course of the study	Drug	1
risperidone	Drug	2
placebo	Other	3

Primary outcome

Positive and Negative Symptom Scale (PANSS) Total Score at Baseline
Time frame: 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.
Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28
Time frame: 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.

8 secondary outcomes

Positive and Negative Symptom Scale (PANSS) Positive Subscale Score
Time frame: Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Negative Subscale Score
Time frame: Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) General Psychopathology Subscale Score
Time frame: Baseline, Day 7, 14, 21, 28
Positive and Negative Symptom Scale (PANSS) Cognition Cluster Subscale Score
Time frame: Baseline, Day 7, 14, 21, 28
Percentage of Participants With Response As Per Positive and Negative Symptom Scale (PANSS) Total Score
Time frame: Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Severity (CGI-S) Score
Time frame: Baseline, Day 7, 14, 21, 28
Clinical Global Impression - Improvement (CGI-I) Score
Time frame: Day 7, 14, 21, 28
Calgary Depression Scale for Schizophrenia (CDSS) Score
Time frame: Baseline, Day 7, 14, 21, 28

Results and safety

Results posted to the registry on 20 Mar 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	37	20
Vabicaserin 50 mg	18	13
Vabicaserin 100 mg	8	3
Vabicaserin 150 mg	19	9
Vabicaserin 200 mg	16	11
Vabicaserin 300 mg	19	14
Vabicaserin 400 mg	12	9
Vabicaserin 600 mg	30	16
Risperidone	43	32

Primary outcome: Positive and Negative Symptom Scale (PANSS) Total Score at Baseline

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	Placebo n = 35	Vabicaserin 50 mg n = 17	Vabicaserin 100 mg n = 8	Vabicaserin 150 mg n = 18	Vabicaserin 200 mg n = 16	Vabicaserin 300 mg n = 18	Vabicaserin 400 mg n = 12	Vabicaserin 600 mg n = 28	Risperidone n = 42
Value	94.74 (11.18)	94.24 (8.42)	96.88 (14.54)	101.33 (12.97)	93.06 (8.84)	94.39 (8.73)	92.83 (10.25)	95.54 (12.46)	91.43 (10.83)

Population analysed: 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.

Primary outcome: Change From Baseline in Positive and Negative Symptom Scale (PANSS) Total Score at Day 28

Time frame: Baseline, Day 28. Least squares mean (Standard Error). Unit: units on a scale

Measure	Placebo n = 21	Vabicaserin 50 mg n = 13	Vabicaserin 100 mg n = 3	Vabicaserin 150 mg n = 10	Vabicaserin 200 mg n = 11	Vabicaserin 300 mg n = 14	Vabicaserin 400 mg n = 9	Vabicaserin 600 mg n = 17	Risperidone n = 32
Value	-17.03 (3.59)	-4.72 (4.87)	-10.26 (8.35)	-5.41 (5.18)	-13.42 (5.17)	-6.13 (4.80)	-13.84 (5.93)	-7.30 (4.09)	-15.59 (3.20)

Placebo vs Vabicaserin 50 mg: Least Squares (LS) Mean Difference: -12.30 (95% CI -24.24 to -0.37), p = 0.043, Mixed Models Analysis
Placebo vs Vabicaserin 100 mg: LS Mean Difference: -6.77 (95% CI -24.70 to 11.16), p = 0.457, Mixed Models Analysis
Placebo vs Vabicaserin 150 mg: LS Mean Difference: -11.61 (95% CI -24.03 to 0.81), p = 0.067, Mixed Models Analysis

Population analysed: 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.

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 37 (10.8%)	28 of 37 (75.7%)	Not reported
Vabicaserin 50 mg	0 of 18 (0%)	12 of 18 (66.7%)	Not reported
Vabicaserin 100 mg	1 of 8 (12.5%)	6 of 8 (75%)	Not reported
Vabicaserin 150 mg	0 of 19 (0%)	11 of 19 (57.9%)	Not reported
Vabicaserin 200 mg	0 of 16 (0%)	13 of 16 (81.3%)	Not reported
Vabicaserin 300 mg	1 of 19 (5.3%)	13 of 19 (68.4%)	Not reported
Vabicaserin 400 mg	2 of 12 (16.7%)	10 of 12 (83.3%)	Not reported
Vabicaserin 600 mg	2 of 30 (6.7%)	23 of 30 (76.7%)	Not reported
Risperidone	3 of 43 (7%)	35 of 43 (81.4%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

33 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing vabicaserin and risperidone in people with Schizophrenia, run by Pfizer at 33 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Positive and Negative Symptom Scale (PANSS) Total Score at Baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00563706.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2014.