Effects of Quetiapine on Ultrastructural Hippocampal and Neurochemical Changes in Patients With Bipolar Disorder: Searching for Antidepressant and Mood Stabilising Neurophysiology

NCT01552837 | Completed

• 4 other identifiers: D1449L000302007-000479-40EK 024/0707-010
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder

Keywords

Diffusion Tensor Imaging,; quetiapine; Bipolar Disorder; hippocampus; Volume Brain Morphometry; Magnetic Resonance Spectroscopy; effect of quetiapine on hippocampal neurogenesis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• safety and tolerability of medical treatment

  every time during the study

• Detection of pharmacologically induced localised volume changes

  after 6 weeks

• Detection of pharmacologically induced localised changes in water content

  after 6 weeks

• Detection of pharmacologically induced neurochemical changes in the medial temporal regions (Glx and NAA, choline)

  after 6 weeks

• Detection of pharmacologically induced differential activation during an episodic memory task measured with fMRI.

  after 6 weeks

Study Arms (2)

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

Drug: Seroquel

Interventions

Seroquel DRUG

for 4 weeks, 300 - 800 mg per day in 2 doses

patients with Bipolar Disorder

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age ranging 18 - 55 years old
• intelligence coefficient (IQ) of minimum 85 as estimated by MWT-B
• MRI compatibility
• for healthy volunteers - no DSM-IV diagnosis
• patients should have had a diagnosis of bipolar disorder in accordance with DSM-IV.

You may not qualify if:

• substances or alcohol abuse or dependence (except caffeine and nicotine) at enrollment;
• medical conditions that would affect absorption, distribution, metabolism or excretion of study treatment;
• unstable or inadequately treated medical illness (diabetes, angina, pectoris, hypertension);
• diabetes mellitus
• patients who in the opinion of the investigator pose a risk of suicide or danger to self or others,
• patients who known intolerance or lack of response to Quetiapine fumarate,
• patients who use of any of the cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, nelfinavir, ritonavir, fluvoxamine and saquinavir) in the 14 days preceding enrollment,
• patients who use of any of the cytochrome P450 inducers (phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort and glucocorticoids) in the 14 days preceding enrollment,
• current treatment of Quetiapine or use of mood stabilizer or antidepressant as co-medication throughout the study.
• lack of inform consent

Sponsors & Collaborators

• RWTH Aachen University: lead

Study Sites (1)

Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen

Aachen, 52074, Germany

Location

Related Publications (3)

• 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.

  PMID: 8019776 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.

  PMID: 16271709 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.

  PMID: 15880391 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Klaus Mathiak, Prof MD

  Department of Psychiatry, Psychotherapy and Psychosomatics, University Hospital Aachen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 13, 2012
• Study Start: December 1, 2007
• Primary Completion: February 1, 2010
• Study Completion: December 1, 2010
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

DE (1)