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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000479-40 | EudraCT Number | ||
| EK 024/07 | Other Identifier | Ethics Commettee Number | |
| 07-010 | Other Identifier | Sponsor's Code |
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The aim of the study was to determine the pharmacological induced equivalents of neurogenesis and synaptic sprouting in the hippocampus, localized volume changes, changes in water content and neurochemical changes in the medial temporal regions.
Quetiapine is an antipsychotic that has mood stabilizing and antidepressant effects (Vieta, 2005). Animal studies showed that the expression of neurotrophins and the subsequent modulation of the neuroplastic processes, including neurogenesis in the hippocampus, play a key role in the mechanism of mood stabilizing (Kim et al., 2004) and antidepressant (Santarelli et al., 2003). Since atypical antipsychotics also have antidepressant and mood stabilizing effect, it is hypothesized that the common mechanism of action in all three pharmacological classes is neurogenesis and synaptic sprouting in the hippocampal region. Thus, the aim of this study was to test this hypothesis.
Quetiapine was associated with antidepressant and mood stabilizing effects in patients with bipolar disorder (Vieta, 2005). The evidence based on animal studies shows that administration of quetiapine attenuates the decrease in levels of brain-derived neurotrophic factor in the hippocampi. This may explain the improved cognitive symptoms in patients with schizophrenia and depression (Luo et al., 2005, Park et al, 2006).
The aim of the study was to determine the pharmacological induced equivalents of neurogenesis and synaptic sprouting in the hippocampus, localized volume changes, changes in water content and neurochemical changes in the medial temporal regions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy volunteers | No Intervention | MRI compatible, no present or past DSM-IV diagnosis | |
| patients with Bipolar Disorder | Active Comparator | MRI compatible, presence of DSM-IV diagnosis for Bipolar Disorder |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroquel | Drug | for 4 weeks, 300 - 800 mg per day in 2 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Anisotropy in hippocampal formation detected with Diffusion Tensor Imaging (DTI) | Detection of pharmacologically induced equivalents of neurogenesis and synaptic sprouting in the hippocampal region. | after 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability of medical treatment | Observation of adverse events and tolerability assessed by vital signs and clinical chemistry | every time during the study |
| Detection of pharmacologically induced localised volume changes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Klaus Mathiak, Prof MD | Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen | Aachen | 52074 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8019776 | Background | Basser PJ, Mattiello J, LeBihan D. Estimation of the effective self-diffusion tensor from the NMR spin echo. J Magn Reson B. 1994 Mar;103(3):247-54. doi: 10.1006/jmrb.1994.1037. | |
| 16271709 | Background | Luo C, Xu H, Li XM. Quetiapine reverses the suppression of hippocampal neurogenesis caused by repeated restraint stress. Brain Res. 2005 Nov 23;1063(1):32-9. doi: 10.1016/j.brainres.2005.09.043. Epub 2005 Nov 4. |
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Measurement with 3D MPRAGE (structural scan)
| after 6 weeks |
| Detection of pharmacologically induced localised changes in water content | differentiation between neurogenesis/sprouting and mere water intake | after 6 weeks |
| Detection of pharmacologically induced neurochemical changes in the medial temporal regions (Glx and NAA, choline) | Measurement of glutamate and N-acetylaspartate in the medial temporal lobe with MRS | after 6 weeks |
| Detection of pharmacologically induced differential activation during an episodic memory task measured with fMRI. | Measurement of BOLD response using fMRI during an episodic memory test | after 6 weeks |
| 15880391 | Background | Vieta E. Mood stabilization in the treatment of bipolar disorder: focus on quetiapine. Hum Psychopharmacol. 2005 Jun;20(4):225-36. doi: 10.1002/hup.689. |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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