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Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia (OXC-SCZ)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00637234
First Posted: March 17, 2008
Last Update Posted: July 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Cologne
  Purpose

Over recent years an approach with the adjunctive administration of various anticonvulsant drugs has been discussed and a limited number of open and controlled studies were performed for carbamazepine, valproic acid, and lamotrigine. While the latter shows promising effects in the long run it has some handling difficulties in the acute treatment of acute psychotic exacerbations. Valproic acid has shown inconsistent effects in schizophrenia with no significant effects in a recent controlled study. Although still controversially discussed, carbamazepine was found to offer beneficial effects in the treatment of schizophrenia. Nonetheless, data on these effects are limited by small sample sizes or poor design of most of the respective studies. Furthermore, the complex pharmacological interactions of new atypical neuroleptics with carbamazepine underline the necessity of alternative strategies in adjuvant treatment of schizophrenia as well as in combined treatment of bipolar disorders with mood stabilizers and neuroleptics.

Oxcarbazepine (OXC) is a new anticonvulsant drug that acts as a pro-drug for the 10-monohydroxy metabolite (MHD), an active metabolite also of carbamazepine that is suggested to be responsible for most of its therapeutic actions. Therefore, the pharmacological action of OXC is very well comparable to carbamazepine whilst there are fewer unwanted side effects of OXC regarding eg. skin rush, and effects on blood compounds or cardiotropic effects.

The effects of OXC on cytochrome CYP3A4 and CYP3A5 are moderate and UDPGT is only slightly affected by OXC, which leads to less interaction with other compounds on a pharmacokinetical level.

In psychiatry, the few studies published until now report positive effects of OXC in bipolar disorders. With regards to our own clinical observations, OXC has shown potential beneficial effects as an adjunct in the treatment of schizophrenia as well that require further evaluation in a controlled study design.


Condition Intervention Phase
Schizophrenia Drug: Oxcarbazepine Drug: Placebo Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Cologne:

Primary Outcome Measures:
  • Amount of Olanzapine Co-medication [ Time Frame: 5 weeks ]

Secondary Outcome Measures:
  • BPRS [ Time Frame: 6 weeks ]
  • Extrapyramidal symptoms [ Time Frame: 6 weeks ]
  • Weight gain [ Time Frame: 6 weeks ]
  • Prolactin levels in plasma [ Time Frame: 6 weeks ]
  • ECG QT-C time elongation [ Time Frame: 6 weeks ]
  • Neurocognitive performance [ Time Frame: 6 week ]

Enrollment: 54
Study Start Date: July 2004
Study Completion Date: July 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Oxcarbazepine
Oxcarbazepine (OXC), 300 mg tablets, up to 600 mg three times daily
Other Names:
  • Trileptal FCT 300MG.002
  • Film-coated tablet
  • Batch No.: X208 0802
  • Code: 3750031.002
  • Date of manufacture: September 2002
  • Date of evaluation: May 2004
Placebo Comparator: 2 Drug: Placebo
Placebo, 300 mg tablets, up to 600 mg three times daily
Other Names:
  • TRL PLA FCT.005
  • Film-coated tablet
  • Batch No.: X207 0802
  • Code: 3750411.005
  • Date of manufacture: September 2002
  • Date of evaluation: May 2004

Detailed Description:

This is an explorative controlled study with Oxcarbazepine (OXC) as an adjunct in the acute treatment of schizophrenia. The study will be performed in subjects between 18 and 50 years of age with an acute schizophrenic or schizophreniform disorder according to DSM-IV. The study will be performed according to Guidelines for Good Clinical Practice (GCP).

The primary hypothesis of this study is that adjunctive treatment with OXC yields at least comparable efficacy regarding antipsychotic actions with lower doses of neuroleptics and consequently substantially fewer adverse events.

A randomised controlled, double blind study is intended. During a 6 weeks treatment trial two groups of patients will be basically treated with olanzapine (starting with 5 mg after one week with an optional, BPRS-controlled step by step increase of about 2,5 mg each following week). Patients will receive a placebo controlled adjunctive therapy with OXC (1800 mg/day). After the initial lead-in of OXC within 7 days (allowing lorazepam as comedication), treatment with olanzapine will be started. Based on biometric calculations, a drop out adjusted sample size of 222 inpatients will be necessary

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of schizophrenia or schizophreniform psychosis according to DSM-IV
  • BPRS score > 36 and BPRS psychosis cluster > 12
  • Ability to provide written informed consent
  • Participants are required an adequate contraception

Exclusion Criteria:

  • Any severe neurological or somatic disorder
  • Other psychiatric disorders including addictive disorders
  • Positive urine drug screening for any compound except benzodiazepines
  • No pregnancy or breast feeding
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00637234


Locations
Germany
Isar-Amper-Klinikum gemeinnützige GmbH, Klinik Taufkirchen (Vils)
Taufkirchen (Vils), Bayern, Germany, 84416
University of Cologne, Dept. of Psychiatry and Psychotherapy
Cologne, NRW, Germany, 50924
Sponsors and Collaborators
University of Cologne
Investigators
Study Director: F. Markus Leweke, MD University of Cologne
  More Information

Additional Information:
Responsible Party: Dr. F. Markus Leweke, University of Cologne
ClinicalTrials.gov Identifier: NCT00637234     History of Changes
Other Study ID Numbers: OXC-SCZ CTRI476BDE06
First Submitted: March 10, 2008
First Posted: March 17, 2008
Last Update Posted: July 24, 2008
Last Verified: July 2008

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Oxcarbazepine
Carbamazepine
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anticonvulsants
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Antimanic Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents