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.
Conditions
Interventions
Trade Name: Seroquel
Product Name: Quetiapine
Pharmaceutical Form: Tablet
INN or Proposed INN: Quetiapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Trade
Sponsors
Department of Psychiatry, RWTH Aachen
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Detection of pharmacologically induced equivalents of neurogenesis and synaptic sprouting in the hippocampal region. Anisotropy in hippocampal formation detected with Diffusion Tensor Imaging (DTI) ;Secondary Objective: Assessment of safety and tolerability of medical treatment (1). Detection of pharmacologically induced (2) localised volume changes, (3) localised changes in water content (differentiation between neurogenesis/sprouting and mere water intake), (4) neurochemical changes in the medial temporal regions (Glx and NAA, choline), (5) differential activation during an episodic memory task measured with fMRI.;Primary end point(s): Anisotropy in hippocampal formation detected with Diffusion Tensor Imaging (DTI) Adverse Events as detailed in 4.4.1 and tolerability assessed by vital signs and clinical chemistry Hippocampal volume measured with Deformation Based Morphometry (DBM) Hippocampal water content measured with QUTE and TAPIR Glx concentration in hippocampus measured with Magnetic Resonance Spectroscopy (MRS) Functional correlates of episodic memory measured by fMRI | — |
Countries
Germany
Outcome results
None listed