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paliperidone; Carbamazepine

Phase 1

Schizophrenia | Small molecule | Psychiatry |Johnson & Johnson|Last Updated: May 18, 2011

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

paliperidone; Carbamazepine · 1 trial · 2 indications

Phase 1 1
NCT00892125A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I DisorderSchizophrenia
COMPLETED64 Analytics
PHASE1COMPLETED
A Study of the Effect of Carbamazepine on the Pharmacokinetics of Paliperidone Extended Release (ER) in Patients With Schizophrenia or Bipolar I Disorder
SchizophreniaUnlock trial analytics

Study Endpoints

Primary Endpoints

to evaluate the effects of a potent enzyme inducer, carbamazepine, on the steady-state pharmacokinetics of orally administered paliperidone ER

Secondary Endpoints

to evaluate the safety and tolerability of the treatments in clinically stable patients with a diagnosis of schizophrenia or bipolar I disorder
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
paliperidone ER; CarbamazepineDRUG -
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Diagnosis of schizophrenia of any subtype (295.10 * 295.20 * 295.30 * 295.60 * 295.90) or bipolar I disorder (296.0x, 296.4x, 296.5x, 296.6x or 296.7), according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) * Clinically stable with no p...

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Frequently asked questions about paliperidone; Carbamazepine

What is paliperidone and carbamazepine used for?

Paliperidone and carbamazepine are being studied for use in schizophrenia. The combination is being investigated in a clinical trial that also includes patients with bipolar I disorder. Paliperidone is an extended release formulation, and carbamazepine is being evaluated for its effect on paliperidone's pharmacokinetics.

Who makes paliperidone and carbamazepine?

Johnson & Johnson (NYSE: JNJ) is developing paliperidone and carbamazepine. The company is conducting a Phase 1 clinical trial to study the effect of carbamazepine on the pharmacokinetics of paliperidone extended release in patients with schizophrenia or bipolar I disorder.

What phase is paliperidone and carbamazepine in?

Paliperidone and carbamazepine are in Phase 1 clinical development. The combination is investigational and has not been approved by the FDA. One Phase 1 trial has been completed, with no active trials currently ongoing.

What clinical trials is paliperidone and carbamazepine in?

Paliperidone and carbamazepine have one completed clinical trial, NCT00892125. This Phase 1 study evaluated the effect of carbamazepine on the pharmacokinetics of paliperidone extended release in patients with schizophrenia or bipolar I disorder. The trial enrolled 64 participants and was uncontrolled.

How does paliperidone and carbamazepine work?

Paliperidone is an atypical antipsychotic that works by blocking dopamine and serotonin receptors in the brain. Carbamazepine is an anticonvulsant that may affect the metabolism of paliperidone. The combination is being studied to understand how carbamazepine influences paliperidone levels in the body.