Quetiapine Related Neurochemical Changes as Measured by Magnetic Resonance Spectroscopy in Schizophrenia

NCT00797927 | Completed Phase 4

• 1 other identifier: 200702010M
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

we aim to examine whether a representative atypical antipsychotic, quetiapine, has different effects from conventional antipsychotics on the magnetic resonance spectroscopy (MRS) markers in schizophrenia patients.

Conditions

Schizophrenia

Keywords

schizophrenia; quetiapine; conventional antipsychotics; magnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (1)

• The change from baseline in neurochemical peak area ratios (NAA/CRE, NAA/CHO, CHO/CRE) at the end of study

  baseline and 28 th day

Secondary Outcomes (1)

• changes from baseline in PANSS

  baseline and 28th day

Study Arms (2)

1. quetiapine

EXPERIMENTAL

quetiapine would replace the original conventional antipsychotic agent

Drug: quetiapine

2. conventional antipsychotics

NO INTERVENTION

Other: no intervention

Interventions

quetiapine DRUG

quetiapine (with equivalent dose to original antipsychotic agent) would replace the original antipsychotic agent for 28 days

Also known as: seroquel

1. quetiapine

no intervention OTHER

keep the original conventional antipsychotic agent for 28 days

Also known as: typical antipsychotics

2. conventional antipsychotics

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of written informed consent
• A diagnosis of schizophrenia or schizoaffective disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
• Females or males aged \> 20 and \< 65 years
• Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment
• Able to understand and comply with the requirements of the study
• Undergoing treatment with a conventional antipsychotic drug and is clinically stable

You may not qualify if:

• Pregnancy or lactation
• 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, 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 enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampicin, St. John's Wort, and glucocorticoids
• Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
• Substance or alcohol dependence at enrolment (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 enrolment
• Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment as judged by the investigator
• Involvement in the planning and conduct of the study
• Previous enrolment or randomisation of treatment in the present study.
• Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
• Subjects with metal prosthesis such as cardiac valves etc
• Severe neurological co-morbidity such as stroke, encephalopathy etc or medical conditions that will compromise on the safety of patients such as acute myocardial infarction, systemic infections etc as judged by the investigator

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Department of Psychiatry, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Tzung-Jeng Hwang, MD

  Department of Psychiatry, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 24, 2008
• First Posted: November 25, 2008
• Study Start: January 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2009
• Last Updated: April 29, 2009

Record last verified: 2009-04

Locations

TW (1)