Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

U

University of Regensburg (UR)

Status and phase

Completed
Phase 4

Conditions

Schizophrenia

Treatments

Drug: Quetiapine

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00554658
D1443L00015

Details and patient eligibility

About

Aim of the study is to assess the effect of quetiapine treatment in neuroleptic naive, first-episode schizophrenic patients on aspects of functional and structural neuroplasticity assessed by means of transcranial magnetic stimulation and voxel-based morphometry. Main outcome measure is a change in gray matter density under quetiapine treatment from baseline to steady-state-treatment after 3 weeks.

Enrollment

30 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • diagnosis of first episode of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) criteria and no history of neuroleptic medication
  • Females and/or males aged 18 to 65 years
  • Mild to moderate schizophrenia

Exclusion criteria

  • Neuroleptic treatment prior to study enrollment
  • 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 enrolment 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 enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
  • Any history of neuroleptic treatment
  • Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  • 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. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
  • Involvement in the planning and conduct of the study
  • History of or evidence of significant brain malformation or neoplasm, head injury, cerebral vascular events, neurodegenerative disorder affecting the brain or prior brain surgery
  • Concomitant treatment with psychotropic drugs (e.g. antidepressive agents, anticonvulsants, other neuroleptics) except benzodiazepines or hypnotics

Trial design

30 participants in 1 patient group

A
Active Comparator group
Description:
Patients will be taken quetiapine for the treatment of first episode schizophrenia.
Treatment:
Drug: Quetiapine

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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