NCT01094249

Brief Summary

The purpose of this study is to evaluate the potential effect of multiple oral doses of an extended release formulation of paliperidone on the pharmacokinetics (blood levels) of valproic acid (VPA) in patients with schizophrenia, bipolar I disorder, or schizoaffective disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_1 schizophrenia

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_1 schizophrenia

Geographic Reach
1 country

3 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

February 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

2 months

First QC Date

February 18, 2010

Last Update Submit

April 7, 2014

Conditions

SchizophreniaBipolar DisorderPsychotic Disorders

Keywords

Paliperidone ERINVEGADivalproex sodiumDepakote ERValproic acidPharmacokineticsR076477BIM1004

Outcome Measures

Primary Outcomes (1)

  • To assess the potential effect of multiple doses of paliperidone ER tablets on the steady state pharmacokinetics of VPA.

    Blood samples collected at specified times on Days 4 through 13.

Secondary Outcomes (1)

  • To evaluate safety and tolerability of paliperidone ER coadministered with divalproex sodium ER

    From time of screening (Day -21 up to Day -2) through the posttreatment follow-up visit 1 week after the end-of-study visit (Day 13 or time of early withdrawal from study)

Study Arms (1)

001

EXPERIMENTAL

divalproex sodium ER/paliperidone ER Divalproex sodium ER (dose determined from the patients prescreening therapeutic dose) once daily from Day 1 through Day 7 and once daily in combination with paliperidone ER 12 mg from Day 8 through Day 12

Drug: divalproex sodium ER/paliperidone ER

Interventions

divalproex sodium ER/paliperidone ERDRUG

Divalproex sodium ER (dose determined from the patients prescreening therapeutic dose) once daily from Day 1 through Day 7 and once daily in combination with paliperidone ER 12 mg from Day 8 through Day 12

001

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
  • Is clinically stable with no psychiatric hospitalization or change in existing mood stabilizers, antipsychotic, or anti-manic drugs for 1 month before screening
  • Taking valproate (valproic acid, sodium valproate, or divalproex sodium) for a minimum of 4 weeks before screening with a stable therapeutic dose for a minimum of 2 weeks and have confirmed therapeutic blood concentrations at screening
  • If a woman, be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before entry and throughout the study
  • If a man, agrees to use an adequate contraception method as deemed appropriate by the Investigator and to not donate sperm using the study and for 3 months after receiving the last dose of study drug

You may not qualify if:

  • Meet DSM-IV criteria for rapid cycling if primary diagnosis is bipolar I disorder
  • DSM-IV diagnosis of alcohol or substance abuse with the exception of nicotine or caffeine dependence, within 12 months before screening
  • Current suicidal ideation or violent tendencies at the time of screening
  • History of neuroleptic malignant syndrome, any malignancy (with exception of basal cell carcinoma) within the past 5 years, any severe pre-existing gastrointestinal narrowing, or any history (or presence) of any cardiovascular, respiratory, neurologic, renal, hepatic, gastrointestinal, endocrine, hematologic, or immunologic disease
  • moderate or severe tardive dyskinesia at the time of screening
  • known allergy or intolerance of study drugs (ie, paliperidone, the parent compound risperidone, valproic acid, sodium valproate, or divalproex sodium) or any of the excipients of the formulations (eg, lactose)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Kissimmee, Florida, United States

Location

Unknown Facility

Austin, Texas, United States

Location

Unknown Facility

Portsmount, Virginia, United States

Location

Related Links

MeSH Terms

Conditions

SchizophreniaBipolar DisorderPsychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Study Officials

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

March 26, 2010

Study Start

February 1, 2009

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations

US(3)