MedDataX Logo

Quetiapine Induced Neuroplasticity in First-episode Schizophrenic Patients

NCT ID: NCT00554658

Last Updated: 2011-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Patients will be taken quetiapine for the treatment of first episode schizophrenia.

Group Type ACTIVE_COMPARATOR

Quetiapine

Intervention Type DRUG

Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 - 800 mg quetiapine per day.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Quetiapine

Quetiapine will be administered open label as clinically required according to current guidelines. Target dose range: 400 - 800 mg quetiapine per day.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Seroquel IR Seroquel Prolong

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

* 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

Exclusion Criteria

* Neuroleptic treatment prior to study enrollment
* Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

AstraZeneca

INDUSTRY

Sponsor Role collaborator

University of Regensburg

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Goeran Hajak

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Goeran Hajak, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Regensburg, Department of Psychiatry

Regensburg, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D1443L00015

Identifier Type: -

Identifier Source: org_study_id