NCT00628420

Brief Summary

To determine the safety and tolerability of ACP-104 after oral administration of single doses in comparison with placebo to schizophrenia or other psychotic disorders.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P50-P75 for phase_1 schizophrenia

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_1 schizophrenia

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2006

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 24, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 5, 2008

Completed
Last Updated

June 28, 2011

Status Verified

February 1, 2008

Enrollment Period

1.8 years

First QC Date

February 24, 2008

Last Update Submit

June 27, 2011

Conditions

Schizophrenia

Keywords

SchizophreniaN-desmethylclozapineclozapinepsychosisrandomizedplacebo studies

Study Arms (3)

1

OTHER

Patients recieved single low dose of ACP-104

Drug: ACP-104

2

OTHER

Patients recieved a high dose of ACP-104

Drug: ACP-104

3

OTHER

Patients recieved a placebo

Drug: Placebo

Interventions

ACP-104DRUG

25mg, 75mg, 125mg, 175mg, 225mg, or 275mg once a day for 2 weeks

1
PlaceboDRUG

patients will be given a placebo: 25mg, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg, 200mg, 225mg, 250mg, 275mg, or 300mg (to match the doses given) daily for 2 weeks.

Also known as: cornstarch capsule
3

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females, who have been surgically sterilized or at least 1 year post menopausal, in good health (based on medical history, physical examination, electrocardiograms, and clinical laboratory tests)
  • Between 20 and 50 years old (inclusive)
  • History of schizophrenia, schizoaffective disorder, bipolar with psychosis, major depression with psychosis, PTSD with psychosis, or psychosis NOS and not experiencing an acute exacerbation of severe psychosis
  • Able to execute informed written consent
  • Willing to follow dietary restrictions as outlined in Section 6.2 General and dietary restrictions,
  • Willing to remain hospitalized for the in-patient portion of the study and return for follow up visit(s) as required by the protocol and as deemed necessary by principal investigator,
  • Will be in need of treatment with an antipsychotic medication,
  • Fluent and literate in English

You may not qualify if:

  • Any patient that has received clozapine within the last three months, or any depot antipsychotic within the last six months,
  • Likely allergy or insensitivity to ACP-104 or clozapine based on known allergies to drugs of the same class, or which in the opinion of the principle investigator, suggests an increased potential for an adverse hypersensitivity to ACP-104
  • Any prior history of drug-induced leukopenia or neutropenia,
  • Any prior history of neuroleptic malignant syndrome
  • History of seizure, epilepsy, severe head injury, multiple sclerosis, or other known neurological condition
  • Prior history of cardiovascular disease, including arrhythmia or myocarditis
  • Abnormal pre-admission vital signs or clinical laboratory evaluations
  • Any patient with a history, within the last three months, of alcohol and/or drug dependency or alcohol and/or drug abuse in the last month
  • History of hepatic or renal disease
  • Any patient scheduled to undergo any surgical procedure during the duration of the study,
  • Any patient taking any concurrent medications for a major medical illness
  • Any patient who has donated plasma or blood within 30 days before the first dose of study medication,
  • Any patient who has received any known hepatic or renal clearance altering agents (e.g., erythromycin, cimetidine, barbiturates, phenothiazines, etc.) for a period of 3 months before the first dose of study medication
  • Ingestion or use of any investigational medication or device within 3 months before the first dose of study medication
  • Acute illness within 5 days before the first dose of study medication
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Veteran's Affairs Medical Center

Dallas, Texas, 75216, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Starch

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

GlucansBiopolymersPolymersMacromolecular SubstancesDietary CarbohydratesCarbohydratesPolysaccharides

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 24, 2008

First Posted

March 5, 2008

Study Start

January 1, 2005

Primary Completion

November 1, 2006

Study Completion

October 1, 2007

Last Updated

June 28, 2011

Record last verified: 2008-02

Locations

US(2)