Trial · NCT00125138

Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease

NCT00125138, Phase 2, Completed, Lundbeck LLC; results first posted 2011-06-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease. Trials, record NCT00125138. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00125138

On this page

Trial

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

Title: Melperone (an Anti-Psychotic) in Patients With Psychosis Associated With Parkinson's Disease
NCT number: NCT00125138
Status: Completed
Phases: Phase 2
Enrollment: 90 participants, actual
Lead sponsor: Lundbeck LLC
Conditions: Parkinson's Disease, Psychotic Disorders
Interventions: Melperone HCl, Melperone HCl, Melperone HCl, Placebo
First posted: 2005-07-29
Last updated: 2011-06-17
Results first posted: 2011-06-17

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Patient Evaluation of Symptoms of Psychosis.	6 weeks (from Baseline to end of Maintenance Period)	The change in the Scale for Assessment of Positive Symptoms (SAPS) total score. The SAPS total score ranges from 0 to 170, with higher scores indicating more severe psychosis.
Secondary	Investigator/Caregiver Evaluations of Motor Function	6 weeks (from Baseline to end of Maintenance Period)	The change in the motor section of the Unified Parkinson's Disease Rating Scale (UPDRS III - motor exam) score. Scores on the UPDRS III - motor exam range from 0 to 108, with higher scores indicating more severe motor symptoms.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Patient Evaluation of Symptoms of Psychosis.	6 weeks (from Baseline to end of Maintenance Period)	All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat \[MITT\] population) were included in the analysis of efficacy.	Scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Investigator/Caregiver Evaluations of Motor Function	6 weeks (from Baseline to end of Maintenance Period)	All randomized subjects who provided informed consent, took at least 1 dose of study drug, and had at least 1 post-baseline efficacy measurement (modified intent-to-treat \[MITT\] population) were included in the analysis of efficacy.	Scores on a scale	MEAN

Source ClinicalTrials.gov

Results by group8

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

Outcome	Group	Value	Spread	Units
Patient Evaluation of Symptoms of Psychosis.	Melperone HCl - 20 mg	-9.8	Standard Error 4.4	Scores on a scale
Patient Evaluation of Symptoms of Psychosis.	Melperone HCl - 40 mg	-12.9	Standard Error 4.0	Scores on a scale
Patient Evaluation of Symptoms of Psychosis.	Melperone HCl - 60 mg	-9.7	Standard Error 3.5	Scores on a scale
Patient Evaluation of Symptoms of Psychosis.	Placebo	-10.0	Standard Error 3.7	Scores on a scale
Investigator/Caregiver Evaluations of Motor Function	Melperone HCl - 20 mg	0.7	Standard Deviation 8.5	Scores on a scale
Investigator/Caregiver Evaluations of Motor Function	Melperone HCl - 40 mg	1.8	Standard Deviation 12.9	Scores on a scale
Investigator/Caregiver Evaluations of Motor Function	Melperone HCl - 60 mg	0.9	Standard Deviation 11.1	Scores on a scale
Investigator/Caregiver Evaluations of Motor Function	Placebo	0.5	Standard Deviation 6.4	Scores on a scale

Source ClinicalTrials.gov

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Melperone HCl - 20 mg	15
Overall Study	STARTED	Melperone HCl - 40 mg	20
Overall Study	STARTED	Melperone HCl - 60 mg	25
Overall Study	STARTED	Placebo	30
Overall Study	COMPLETED	Melperone HCl - 20 mg	12
Overall Study	COMPLETED	Melperone HCl - 40 mg	17
Overall Study	COMPLETED	Melperone HCl - 60 mg	21
Overall Study	COMPLETED	Placebo	25
Overall Study	NOT COMPLETED	Melperone HCl - 20 mg	3
Overall Study	NOT COMPLETED	Melperone HCl - 40 mg	3

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events40

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	Urinary tract infection	Infections and infestations	Melperone HCl - 20 mg	2	15
other	Urinary tract infection	Infections and infestations	Melperone HCl - 40 mg	2	19
other	Urinary tract infection	Infections and infestations	Melperone HCl - 60 mg	0	25
other	Urinary tract infection	Infections and infestations	Placebo	1	30
other	Parkinson's Disease	Nervous system disorders	Melperone HCl - 20 mg	2	15
other	Parkinson's Disease	Nervous system disorders	Melperone HCl - 40 mg	4	19
other	Parkinson's Disease	Nervous system disorders	Melperone HCl - 60 mg	5	25
other	Parkinson's Disease	Nervous system disorders	Placebo	4	30
other	Somnolence	Nervous system disorders	Melperone HCl - 20 mg	2	15
other	Somnolence	Nervous system disorders	Melperone HCl - 40 mg	3	19

1 to 10 of 40Source ClinicalTrials.gov

See all 40 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Melperone HCl - 20 mg
Total, all-cause mortality	Melperone HCl - 40 mg
Total, all-cause mortality	Melperone HCl - 60 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Melperone HCl - 20 mg	6	15
Total, other adverse events	Melperone HCl - 40 mg	8	19
Total, other adverse events	Melperone HCl - 60 mg	10	25
Total, other adverse events	Placebo	6	30
Total, serious adverse events	Melperone HCl - 20 mg	2	15
Total, serious adverse events	Melperone HCl - 40 mg	2	19

1 to 10 of 12Source ClinicalTrials.gov

See all 12 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.

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/NCT00125138

GET https://conductscience.org/api/trials/v1/NCT00125138/events?page=2

API reference For AI assistants