DepressionNCT02451306
Effect of Quetiapine on Brain Activity Patterns in Patients With Heightened Risk of Bipolar Disorder
A study testing Quetiapine in people with Depression and Bipolar Disorder, run by RWTH Aachen University at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Depression, Bipolar Disorder
- What is being tested?
- Quetiapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2015to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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:
- positive family history (i.e. first or second order relatives with BPD, schizoaffective or schizophrenic psychosis, mania or suicide attempt)
- initial manifestation before 30 years of age
- initial manifestation after childbirth
- suicide attempt in the past
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
Lina Winkler, M.Sc. contact
Germany1 site
Clinic for psychiatry, psychotherapy and psychosomatic, RWTH Aachen University Hospital
Aachen, North Rhine-Westphalia, 52074 Aachen
About this study
Official title: Cognitive Control and Functional Connectivity During Resting State in Patients With Heightened Risk of Bipolar Disorder - a Quetiapine Challenge
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.
- Conditions
- Depression, Bipolar Disorder
- Being tested
- Quetiapine, Placebo
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuetiapineDrug
Also called Seroquel Prolong
See information in arm description.
PlaceboDrug
See information in arm description.
| Study group | Role | What they receive |
|---|---|---|
| Quetiapine | Experimental | 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. Receives: Drug: Quetiapine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
| Control-group | No intervention | 18 depressive patients without a heightened risk for BPD will not receive any medication apart from their standard antidepressant therapy (control-group). |
What is being measured
The primary outcome is the main question the study is designed to answer.
BOLD signal during a combined inhibition-reward-task
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).
Measured: Baseline (Day 0)
Functional connectivity in the default mode network during resting state (rstfMRI)
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).
Measured: Baseline (Day 0)
Structural differences in brain anatomy (MRI)
At baseline (day 0) the risk-group and control-group will be compared on structural differences in brain anatomy (MRI).
Measured: Baseline (Day 0)
Structural integrity of nerve fibres (DTI)
At baseline (day 0) the risk-group and control-group will be compared on structural integrity of nerve fibres (DTI).
Measured: Baseline (Day 0)
Effect of quetiapine on brain measures
After the quetiapine/ placebo intervention the risk-group will be compared whether there are changes from baseline in outcome measures 1 to 4.
Measured: Visit 4 (Day 56)
Secondary outcomes (3)
Plasma levels of quetiapine
Blood samples of the patients of the risk group will be obtained to analyse the plasma levels of quetiapine.
Measured: Visit 4 (Day 56)
Change over time in affect and psychopathology
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.
Measured: Baseline (Day 0), Visit 4 (Day 56), Follow-up (after 1 year)
Personality
All patients (risk-group and control group) will be assessed with questionnaires of personality (TCI-R, BIS-15, RS-13).
Measured: Baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frank Schneider, Univ.-Prof., Study director, University Hospital, Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02451306
- Sponsor's protocol ID
- EK018/15
- Status last verified
- May 2015
- First submitted
- 22 Apr 2015
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Control and Functional Connectivity During Resting State in Patients With Heightened Risk of Bipolar Disorder - a Quetiapine Challenge
- ClinicalTrials.gov ID
- NCT02451306
- Acronym / sponsor ID
- EK018/15
- Conditions
- Depression, Bipolar Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 21 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Quetiapine | Experimental | Drug: Quetiapine18 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. |
| Placebo | Placebo comparator | Drug: Placebo18 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. |
| Control-group | No intervention | –18 depressive patients without a heightened risk for BPD will not receive any medication apart from their standard antidepressant therapy (control-group). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuetiapineAlso: Seroquel ProlongSee information in arm description. | Drug | Quetiapine |
| PlaceboSee information in arm description. | Drug | Placebo |
Primary outcome
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.
3 secondary outcomes
Plasma levels of quetiapine
Time frame: Visit 4 (Day 56)
Change over time in affect and psychopathology
Time frame: Baseline (Day 0), Visit 4 (Day 56), Follow-up (after 1 year)
Personality
Time frame: Baseline (Day 0)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lina Winkler, M.Sc. contact
Frank Schneider, Univ.-Prof. study director
University Hospital, Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quetiapine in people with Depression and Bipolar Disorder, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lina Winkler, M.Sc. (liwinkler@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD signal during a combined inhibition-reward-task (time frame: Baseline (Day 0)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2015.