Functional neuroanatomy and regional metabolism in depressed patients with quetiapin: An fMRI-guided MRS study on a 7 Tesla scanner

Phase 1

• Conditions: Patients with Bipolar affective disorder

• Registration Number: EUCTR2006-002006-60-DE
• Lead Sponsor: Otto-von-Guericke University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-06-07
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Provision of written informed consent
2.A diagnosis of depression in BP by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
3.Females and males aged between 18 and 60 years
4.Able to understand and comply with the requirements of the study
5.HAM-D > 20
6.Presence of affective and cognitive symptoms according to HAM-D and MADRAS

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Pregnancy or lactation
2.Any DSM-IV Axis I disorder not defined in the inclusion criteria
3.Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
4.Known intolerance or lack of response to quetiapine fumarate, as judged by the investigator
5.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
6.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
7.Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
8.Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
9.Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
10.Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
11.Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
12.Involvement in the planning and conduct of the study
13.Previous enrolment or randomisation of treatment in the present study.
14.Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
15.Treatment with other neuroleptics or other psychotropic drugs (beta blocker, etc.)
16.Diagnosis of organic depression, Dementia, or Anxiety Disorder (according to DSM IV)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: Depressed patients shall include both those with and without predominant cognitive symptoms. Neuroanatomical and metabloic distinction between bipolar patients with and without cognitive symptoms.;Main Objective: The general aim is the investigation of the functional neuroanatomy and regional metabolism in patients with depression in bipolar patients before and after treatment with quetiapin. Using a 7 Tesla scanner, functional subcortical-cortical neuroanatomy will be revealed in functional magnetic resonance imaging (fMRI) whereas regional metabolism will be investigated with magnetoresonancespectroscopy (MRS).;Primary end point(s): The endppoints are neuroanatomical and metabolic markers for therapeutic response to quetiapin after 6 weeks of treatment in bipolar disorder