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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
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 54 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder

Arm Intervention/treatment
Experimental: Quetiapine

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.

Drug: Quetiapine
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.

Drug: Placebo
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).



Primary Outcome Measures :
  1. 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).


  2. 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).

  3. 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).

  4. 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).

  5. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of depressive episode (F32.X, F33.X) with duration less than < 6 months
  • max. three previous episodes of illness
  • no manic or hypomanic episodes in the past
  • current treatment with one antidepressant
  • MRI-compatibility
  • unequivocal understanding of study information and autonomous consent
  • for women: negative pregnancy test
  • for risk-group:

    • 14 or more points on hypomania checklist (HCL-32)
    • additionally at least one of the following four risk factors:

      1. positive family history (i.e. first or second order relatives with BPD, schizoaffective or schizophrenic psychosis, mania or suicide attempt)
      2. initial manifestation before 30 years of age
      3. initial manifestation after childbirth
      4. suicide attempt in the past

Exclusion Criteria:

  • additional diagnoses of psychiatric disorders (Organic, including symptomatic, mental disorders [F0X.X]; mental and behavioural disorders due to psychoactive substance use [F1X.X]; schizophrenia, schizotypal and delusional disorders [F2X.X]; mental retardation [F7X.X])
  • chronic or acute physical disease
  • individuals who are in a dependence- or work-relation with the sponsor
  • limited or annulled legal capacity
  • court or administrative order for hospitalisation
  • for women: pregnancy, nursing period or unsafe contraceptive methods
  • for the risk group:

    • clinical relevant changes in clinical chemistry, hematology, EEG or EKG
    • known contraindication for quetiapine (e.g. hypersensitivity to [active] ingredient[s], HIV-protease inhibitors, antimycotics, antibiotics)

Information from the National Library of Medicine

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


Contacts
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Contact: Lina Winkler, M.Sc. liwinkler@ukaachen.de

Locations
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Germany
Clinic for psychiatry, psychotherapy and psychosomatic, RWTH Aachen University Hospital
Aachen, NRW, Germany, 52074 Aachen
Sponsors and Collaborators
RWTH Aachen University
Investigators
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Study Director: Frank Schneider, Univ.-Prof. University Hospital, Aachen

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Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT02451306     History of Changes
Other Study ID Numbers: EK018/15
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: May 21, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Quetiapine Fumarate
Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs