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Trial record 19 of 40 for:    CARBAMAZEPINE AND Valproic Acid

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

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ClinicalTrials.gov Identifier: NCT00637234
Recruitment Status : Completed
First Posted : March 17, 2008
Last Update Posted : July 24, 2008
Sponsor:
Information provided by:
University of Cologne

Tracking Information
First Submitted Date  ICMJE March 10, 2008
First Posted Date  ICMJE March 17, 2008
Last Update Posted Date July 24, 2008
Study Start Date  ICMJE July 2004
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
Amount of Olanzapine Co-medication [ Time Frame: 5 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00637234 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2008)
  • BPRS [ Time Frame: 6 weeks ]
  • Extrapyramidal symptoms [ Time Frame: 6 weeks ]
  • Weigth 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia
Official Title  ICMJE Oxcarbazepine as an Adjunct of Antipsychotic Therapy in Acute Schizophrenia
Brief Summary

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.

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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Drug: Oxcarbazepine
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2008)
54
Original Estimated Enrollment  ICMJE
 (submitted: March 10, 2008)
80
Actual Study Completion Date  ICMJE July 2008
Actual Primary Completion Date April 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00637234
Other Study ID Numbers  ICMJE OXC-SCZ CTRI476BDE06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr. F. Markus Leweke, University of Cologne
Study Sponsor  ICMJE University of Cologne
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: F. Markus Leweke, MD University of Cologne
PRS Account University of Cologne
Verification Date July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP