Trial · NCT00044044

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

NCT00044044, Phase 2, Completed, Sumitomo Pharma America, Inc.; results first posted 2011-04-12

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia. Trials, record NCT00044044. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00044044

On this page

Trial

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

Title: A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia
NCT number: NCT00044044
Status: Completed
Phases: Phase 2
Enrollment: 356 participants, actual
Lead sponsor: Sumitomo Pharma America, Inc.
Conditions: Schizophrenia
Interventions: Lurasidone 20 mg, Lurasidone 40mg, Lurasidone 80 mg, Haloperidol 10mg, Placebo
First posted: 2002-08-20
Last updated: 2014-04-17
Results first posted: 2011-04-12

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	Baseline and 6 weeks	The BPRS consists of 18 ordered categorical items (from "not present" to "extremely severe," on a 1- to 7-point scale), each developed to assess patient symptomatology in a relatively discrete symptom area. The BPRS will be extracted from the PANSS by adding the scores of the 18 items (P2 to P7, N1, N2, and G1 to G10) of the PANSS and will not be assessed separately. The minimum score on the BPRS is 18 and the maximum is 126. The higher number indicates a worsening of schizophrenia.
Secondary	Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	Baseline and 6 weeks	The PANSS Positive and Negative Syndrome Scale)is a 30-item scale that evaluates positive, negative, and other symptoms in patients with schizophrenia. Each item is rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme). Scores range from 30-210 with higher scores representing a worsening of schizophrenia.
Secondary	Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores	Baseline and 6 weeks	The CGI Severity (CGI-S) assesses the severity of illness of the patient relative to the particular population on a 7-point scale ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Secondary	Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores	Baseline and 6 weeks	The MADRS is a 10-item rating scale that assesses apparent and reported sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty in concentration, and lack of interest. Each item is scored on a 7-point scale with a score of 0 reflecting no symptoms and a score of 6 reflecting symptoms of maximum severity.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	Baseline and 6 weeks	Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	Baseline and 6 weeks	Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to the End of the Double-blind Treatment in the CGI-S (Clinical Global Impression of Severity) Scores	Baseline and 6 weeks	Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline to the End of the Double-blind Treatment in the MADRS (Montgomery Asberg-Depression Scale) Scores	Baseline and 6 weeks	Intent-to-Treat Division of Neuropharmacological Drug Products Last Observation Carried Forward (ITT-DNDP-LOCF). The ITT-DNDP-LOCF population will include all randomized patients who received at least one dose of study medication and who had at least one efficacy evaluation at Day 3 or beyond, during the double-blind treatment period.	units on scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	20 mg	-5.0	Standard Error 1.38	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	40 mg	-5.2	Standard Error 1.44	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	80 mg	-8.0	Standard Error 1.40	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	10 mg Haloperidol	-9.8	Standard Error 1.37	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the BPRS (Brief Psychiatric Rating Scale)Total Score	Placebo	-7.9	Standard Error 1.38	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	20 mg	-7.1	Standard Error 2.31	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	40 mg	-7.2	Standard Error 2.42	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	80 mg	-13.6	Standard Error 2.34	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	10 mg Haloperidol	-16.0	Standard Error 2.29	units on a scale
Change From Baseline to the End of the Double-blind Treatment in the PANSS (Positive and Negative Syndrome Scale) Scores	Placebo	-12.3	Standard Error 2.32	units on a scale

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	20 mg	71
Overall Study	STARTED	40 mg	69
Overall Study	STARTED	80 mg	71
Overall Study	STARTED	10 mg Haloperidol	73
Overall Study	STARTED	Placebo	72
Overall Study	COMPLETED	20 mg	27
Overall Study	COMPLETED	40 mg	28
Overall Study	COMPLETED	80 mg	31
Overall Study	COMPLETED	10 mg Haloperidol	29
Overall Study	COMPLETED	Placebo	36

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events165

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	Events
other	Abdominal Discomfort	Gastrointestinal disorders	20 mg	1	71	1
other	Abdominal Discomfort	Gastrointestinal disorders	40 mg	0	67	0
other	Abdominal Discomfort	Gastrointestinal disorders	80 mg	0	71	0
other	Abdominal Discomfort	Gastrointestinal disorders	10 mg Haloperidol	5	72	5
other	Abdominal Discomfort	Gastrointestinal disorders	Placebo	1	72	1
other	Constipation	Gastrointestinal disorders	20 mg	2	71	2
other	Constipation	Gastrointestinal disorders	40 mg	1	67	1
other	Constipation	Gastrointestinal disorders	80 mg	6	71	6
other	Constipation	Gastrointestinal disorders	10 mg Haloperidol	3	72	3
other	Constipation	Gastrointestinal disorders	Placebo	9	72	9

1 to 10 of 165Source ClinicalTrials.gov

See all 165 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	20 mg
Total, all-cause mortality	40 mg
Total, all-cause mortality	80 mg
Total, all-cause mortality	10 mg Haloperidol
Total, all-cause mortality	Placebo
Total, other adverse events	20 mg	49	71
Total, other adverse events	40 mg	51	67
Total, other adverse events	80 mg	51	71
Total, other adverse events	10 mg Haloperidol	58	72
Total, other adverse events	Placebo	50	72

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
39831535	DERIVED

Source PubMed

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00044044

GET https://conductscience.org/api/trials/v1/NCT00044044/events?page=2

API reference For AI assistants