Effects of quetiapine on ultrastructural hippocampal and neurochemical changes in patients with bipolar disorder: searching for the antidepressant and mood stabilising neurophysiology

• Conditions: Bipolar disorder is a common psychiatric disorder which is characterised by manic and depressive states. The mood stabilizing effect of novel antipsychotics seems to be modulation of neuronal plasticity in the hippocampus. The aim of the study is to detect pharmacologically induced equivalents of neurogenesis and synaptic sprouting in the hippocampal region, localised volume changes or changes in water content and neurochemical changes in the medial temporal regions in humans.

• Registration Number: EUCTR2007-000479-40-DE
• Lead Sponsor: Department of Psychiatry, RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-26
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Provision of written informed consent
A diagnosis of bipolar disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); patients only (n=20)
No current or history of psychiatric disorder by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV); healthy controls only (n=20)
Females and males, aged 18-55 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; IQ of at least 85 (estimated by MWT-B)

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
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: (P450 3A4 inhibitors) 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
Use of (cytochrome P450) inducers 14 days preceding enrollment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids
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
Use of 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
Unstable or inadequately treated medical illness (e.g. diabetes, angina pectoris, hypertension) as judged by the investigator
An absolute neutrophil count (ANC) of ?1.5 x 109 per liter
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
The usual MR-criteria apply. Persons with electrical (such as cardiac pulse generator) or metal implants, backache, heavy overweight, metallic tattoos or pregnancy are excluded.

Study & Design

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