Effect of Quetiapine on Brain Activity Patterns in Patients With Heightened Risk of Bipolar Disorder
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|ClinicalTrials.gov Identifier: NCT02451306|
Recruitment Status : Unknown
Verified May 2015 by RWTH Aachen University.
Recruitment status was: Not yet recruiting
First Posted : May 21, 2015
Last Update Posted : May 21, 2015
Bipolar disorder (BPD) is often misdiagnosed as unipolar depression. This leads to inadequate treatment and can have negative impact on the course of the disease. There is now preliminary evidence that patients with unipolar and bipolar depression as well as healthy individuals with a heightened risk of BPD can be distinguished from each other based on their brain activity patterns and functional connectivity during resting state.
However, the impact of pharmacological treatment on these functional brain measures have not yet been clarified. For common antidepressants it has been shown that they seem to normalise aberrant brain activity patterns and functional connectivity. The problem is that some antidepressants can induce mania or accelerate pathological cycling in depressive patients with unrecognised BPD. Therefore, pharmacological drugs with mood-stabilising properties such as quetiapine are more and more prescribed. Although the effectiveness and tolerability have been proven, the neuronal effects of these adjunctive treatments are not clear. The aim of the study is thus to investigate the impact of quetiapine on measures of brain activity in depressive patients with a heightened risk of BPD. Moreover, the investigators want to examine whether the investigators can distinguish depressive patients with a heightened risk of BPD from depressive patients without a heightened risk of BPD using neuroimaging techniques, and whether these measures can predict the course of the disease.
|Condition or disease||Intervention/treatment||Phase|
|Depression Bipolar Disorder||Drug: Quetiapine Drug: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Basic Science|
|Official Title:||Cognitive Control and Functional Connectivity During Resting State in Patients With Heightened Risk of Bipolar Disorder - a Quetiapine Challenge|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2018|
18 patients of the risk-group will receive quetiapine (Seroquel Prolong (c)) for 8 weeks in adjunction to their antidepressant standard therapy. Group allocation is randomised and double-blind.
Dosages: 50mg (day 1-3), 100mg (day 4-6) and 150mg (from day 7 onwards). Administration: Quetiapine will be given once daily before bedtime, not together with a meal and swallowed as a whole.
See information in arm description.
Other Name: Seroquel Prolong
Placebo Comparator: Placebo
18 patients of the risk-group will receive placebo for 8 weeks in adjunction to their antidepressant standard therapy. Group allocation is randomised and double-blind.
The placebo does not contain any psychoactive substance.
See information in arm description.
No Intervention: Control-group
18 depressive patients without a heightened risk for BPD will not receive any medication apart from their standard antidepressant therapy (control-group).
- BOLD signal during a combined inhibition-reward-task [ Time Frame: Baseline (Day 0) ]
At baseline (day 0) the risk-group and control-group will be compared on BOLD signal (and behavioural data) during a combined inhibition-reward-task (neuronal correlate of cognitive control) (fMRI).
These measures will be obtained once again at visit 4 (day 56) in the risk-group to evaluate the impact of quetiapine (i.e. change from baseline measure).
- Functional connectivity in the default mode network during resting state (rstfMRI) [ Time Frame: Baseline (Day 0) ]At baseline (day 0) the risk-group and control-group will be compared on functional connectivity in the default mode network during resting state (rstfMRI).
- Structural differences in brain anatomy (MRI) [ Time Frame: Baseline (Day 0) ]At baseline (day 0) the risk-group and control-group will be compared on structural differences in brain anatomy (MRI).
- Structural integrity of nerve fibres (DTI) [ Time Frame: Baseline (Day 0) ]At baseline (day 0) the risk-group and control-group will be compared on structural integrity of nerve fibres (DTI).
- Effect of quetiapine on brain measures [ Time Frame: Visit 4 (Day 56) ]After the quetiapine/ placebo intervention the risk-group will be compared whether there are changes from baseline in outcome measures 1 to 4.
- Plasma levels of quetiapine [ Time Frame: Visit 4 (Day 56) ]Blood samples of the patients of the risk group will be obtained to analyse the plasma levels of quetiapine.
- Change over time in affect and psychopathology [ Time Frame: Baseline (Day 0), Visit 4 (Day 56), Follow-up (after 1 year) ]All patients (risk-group and control group) will be assessed with questionnaires tapping affect and psychopathology (MADRS, YMRS, CGI, PANSS, BDI-II, Bf-S, SWN-K, EPS, BARS, C-SSRS, NGASR). These measures will be obtained at three different time points to evaluate the respective change over time.
- Personality [ Time Frame: Baseline (Day 0) ]All patients (risk-group and control group) will be assessed with questionnaires of personality (TCI-R, BIS-15, RS-13).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451306
|Contact: Lina Winkler, M.Sc.||email@example.com|
|Clinic for psychiatry, psychotherapy and psychosomatic, RWTH Aachen University Hospital|
|Aachen, NRW, Germany, 52074 Aachen|
|Study Director:||Frank Schneider, Univ.-Prof.||University Hospital, Aachen|