Genes, Intermediate Phenotypes and Response to Quetiapine RX

This study has suspended participant recruitment.
(Study stopped due to the relatively limited mean reduction in PANSS scores (symptomatology).)
Sponsor:
Information provided by:
University of Bari
ClinicalTrials.gov Identifier:
NCT01044914
First received: January 7, 2010
Last updated: March 3, 2011
Last verified: June 2010
  Purpose

Pharmacological treatment of schizophrenia is still characterized by a certain proportion of patients who are resistant to common antipsychotics. Variability in individual response ranges from patients who experience complete or near complete symptom remission to a subset of patients who remain treatment-refractory despite extensive drug trials over years. The investigators propose to take advantage of the simultaneous acquisition of clinical and of intermediate phenotypes to ascertain the possible contribution of SNPs within putative causative genes to response to treatment with quetiapine XR.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Clinical and Intermediate Phenotypes to Assess Response to Quetiapine: the Role of Putative Causative Genes

Resource links provided by NLM:


Further study details as provided by University of Bari:

Primary Outcome Measures:
  • The primary outcome measure will be the change from baseline in clinical symptoms assessed by PANSS scores measures based on BDNF genotype in schizophrenic patients after quetiapine XR treatment [ Time Frame: after 56 days of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study will be carried out in a hospital unit of the psychiatric assistance system.We will recruit 100 patients with schizophrenia with recent exacerbation of psychotic symptomatology.

Criteria

Inclusion Criteria:

  • Provision of written informed consent
  • Diagnosis of schizophrenia using the Structured Clinical Interview for Diagnosis for the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition
  • Male or female patients aged between 18 and 65 years
  • Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin test at enrollment
  • Able to understand and comply with the requirements of the study
  • Patients with a cut off value for PANSS more than 75

Exclusion Criteria:

  • Pregnancy or lactation
  • Any DSM-IV Axis I disorder not defined in the inclusion criteria
  • Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  • Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
  • Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrollment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
  • Use of any of the following cytochrome P450 inducers in the 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
  • Administration of a depot antipsychotic injection within one dosing interval before randomization
  • Patients treated with clozapine within 28 days before the enrollment
  • Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence)
  • Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrollment
  • Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  • Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
  • Involvement in the planning and conduct of the study
  • Previous enrollment or randomization of treatment in the present study
  • Participation in another drug trial within 4 weeks prior to enrollment into this study or longer in accordance with local requirements
  • A patient with Diabetes Mellitus
  • An absolute neutrophil count of ¬1.5 x 109 per liter
  • Pre-existing Organic Mental Disorder or Mental Retardation.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044914

Locations
Italy
Clinica Psichiatrica - Azienda Ospedaliera Policlinico Bari
Bari, Italy, 70124
Sponsors and Collaborators
University of Bari
  More Information

No publications provided

Responsible Party: Marcello Nardini, Department of Neurology and Psychiatry
ClinicalTrials.gov Identifier: NCT01044914     History of Changes
Other Study ID Numbers: 2009-013028-21
Study First Received: January 7, 2010
Last Updated: March 3, 2011
Health Authority: Italy: The Italian Medicines Agency

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on April 21, 2014