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divalproex/paliperidone

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: Apr 8, 2014

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment9

FDA Designations

No designations recorded

Clinical trial landscape

divalproex/paliperidone · 1 trial · 3 indications

Phase 1 1
NCT01094249A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective DisorderSchizophrenia
COMPLETED9 Analytics
PHASE1COMPLETED
A Drug Interaction Study of Valproic Acid and Paliperidone Extended-Release (ER) in Patients With Schizophrenia, Bipolar I Disorder, or Schizoaffective Disorder
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

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 Endpoints

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)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP

Treatment Arms

ArmTypeDescription
001EXPERIMENTALdivalproex 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

Interventions

NameTypeDescription
divalproex sodium ER/paliperidone ERDRUGDivalproex 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
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * 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 an...

Countries:United States
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Frequently asked questions about divalproex/paliperidone

What is divalproex/paliperidone used for in schizophrenia?

Divalproex/paliperidone is an investigational small-molecule combination being studied for use in schizophrenia. It is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this psychiatric condition.

Who makes divalproex/paliperidone?

Divalproex/paliperidone is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The combination is in early-stage clinical development for schizophrenia.

What phase is divalproex/paliperidone in?

Divalproex/paliperidone is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 1 study has been completed as part of its early development program.

What clinical trials is divalproex/paliperidone in?

Divalproex/paliperidone has one completed clinical trial, NCT01094249, a Phase 1 drug interaction study of valproic acid and paliperidone extended-release in patients with schizophrenia, bipolar I disorder, or schizoaffective disorder. The study enrolled 9 participants in the United States.

Is divalproex/paliperidone the same as valproic acid and paliperidone?

Divalproex/paliperidone refers to a combination of valproic acid and paliperidone extended-release, as studied in clinical trial NCT01094249. The trial investigated the drug interaction between these two components in patients with schizophrenia and related psychiatric disorders.