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A Study in People With Depression to Test the Effects of BI 1358894 on Parts of the Brain That Are Involved in Emotions

A Single Dose, Randomized, Placebo Controlled Phase I Study on the Effects of BI 1358894 on Functional MRI Measurements in an Emotional Processing Paradigm in Patients With Major Depressive Disorder

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03854578
Enrollment
73
Registered
2019-02-26
Start date
2019-03-12
Completion date
2019-09-23
Last updated
2025-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder, Major

Brief summary

To assess the effect of a single dose of BI 1358894 compared to placebo on BOLD responses in modulating brain processing of emotional and cognitive stimuli on the amygdala and related brain structure using fMRI in in unmedicated patients with depression.

Interventions

Film-coated tablet

DRUGPlacebo matching BI 1358894

Film-coated tablet

DRUGCitalopram

Film-coated tablet

Sponsors

Boehringer Ingelheim
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients having a diagnosis of a MDD according to Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) (single episode or recurrent) with a MADRS total score between ≥ 7 and \< 26 at screening. * Male or female aged 18 to 45 years, inclusive at screening. * Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control. * Patients must be, in the opinion of the Investigator, capable of and eligible for completing the fMRI and tasks. * Patients must be right-handed. * Patients must have acceptable weight as defined by BMI (weight \[kg\]/height \[m\]²) range of 18 to 30 kg/m², inclusive at Visit 1. * Patients must be a non-smoker or light smoker (≤ 5 cigarettes per day). * Patients must have signed the informed consent form prior to the first study-related procedure indicating they understand the purpose of and procedures required for the study and are willing to participate in the study. * Further inclusion criteria apply

Exclusion criteria

* Meeting any diagnostic criteria for a major psychiatric disorder (other than MDD), as determined by DSM-V at screening. * Has received a prescribed medication (including antidepressants) within 28 days prior to Visit 1 (apart from the contraceptive pill) or having received over the counter medication (including pain killers) within 10 days prior to screening. Participants who have taken prescription medication may still be entered into the study, if, in the opinion of the Investigator, the medication received will not interfere with the study procedures or compromise safety. * Patients where it is foreseen (per investigator judgement) that a delay of initiation of standard of care therapy for the depressive disorder to 14 days after day 1 of Visit 2 is medically not justifiable. * A history of alcohol or substance dependence or abuse within the last 12 months from Visit 1. * Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 or 5 for ideation on the C-SSRS, or a history of suicidal behavior within the past year, as validated by the C-SSRS at screening or treatment visit. * Has a history of, or presents (in the opinion of the Investigator) with, significant neurological or psychiatric conditions (such as stroke, traumatic brain injury, seizures, space occupying lesions, multiple sclerosis, Parkinson's disease, vascular dementia, transient ischemic attack, schizophrenia, blackouts requiring hospitalisation). * A planned medical treatment within the study period that might interfere with the study procedures. * Further

Design outcomes

Primary

MeasureTime frameDescription
Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)A 50 min scan, 6 hours following drug intake.The primary endpoint was the mean BOLD signal % change in an emotional paradigm, based on the emotional faces from the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) in the corticolimbic system comprising the following eight brain regions of interest: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right

Secondary

MeasureTime frameDescription
Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).A 50 min scan, 6 hours following drug intake.The secondary endpoint was the mean BOLD signal % change in an emotional paradigm (affective picture set - OASIS task) in the corticolimbic system, consisting of eight brain regions: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right

Countries

Germany

Participant flow

Recruitment details

A single dose, randomized, placebo controlled Phase I study on the effects of BI 1358894 on functional magnetic resonance Imaging measurements in an emotional processing paradigm in patients with Major Depressive Disorder

Pre-assignment details

All subjects were screened for eligibility to participate in trial. Subjects visited specialist site to ensure that they met all implemented inclusion/exclusion criteria, Subjects were not to be randomised to trial drug if any of the specific entry criteria was violated

Participants by arm

ArmCount
Placebo Matching to BI 1358894
Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 matching placebo the patient receive 1 film-coated tablet of Placebo.
24
Citalopram
Oral administration of single dose of BI 1358894 matching placebo (4 film-coated tablets) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the first administration of BI 1358894 matching placebo the patient receive a oral administration of single dose of 20 milligram (mg) Citalopram (1 tablet of 20 mg).
24
BI 1358894
Oral administration of single dose of 100 milligram (mg) BI 1358894 (4 film-coated tablets of 25 mg) with 240 milliliter (mL) of water after an high-fat, high-calorie breakfast. Three hours after the administration of BI 1358894 the patient receive 1 film-coated tablet of Placebo.
25
Total73

Baseline characteristics

CharacteristicPlacebo Matching to BI 1358894CitalopramBI 1358894Total
Age, Continuous30.1 Years
STANDARD_DEVIATION 5.6
30.8 Years
STANDARD_DEVIATION 6.5
31.5 Years
STANDARD_DEVIATION 6.8
30.8 Years
STANDARD_DEVIATION 6.3
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants0 Participants0 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants24 Participants25 Participants71 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
1 Participants2 Participants0 Participants3 Participants
Race (NIH/OMB)
Black or African American
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
23 Participants21 Participants25 Participants69 Participants
Sex: Female, Male
Female
19 Participants16 Participants13 Participants48 Participants
Sex: Female, Male
Male
5 Participants8 Participants12 Participants25 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 250 / 230 / 230 / 2
other
Total, other adverse events
13 / 2513 / 2321 / 232 / 2
serious
Total, serious adverse events
0 / 250 / 230 / 230 / 2

Outcome results

Primary

Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)

The primary endpoint was the mean BOLD signal % change in an emotional paradigm, based on the emotional faces from the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP) in the corticolimbic system comprising the following eight brain regions of interest: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right

Time frame: A 50 min scan, 6 hours following drug intake.

Population: Evaluable set (ES): This patient set included all randomised patients who performed the functional Magnetic Resonance Imaging (fMRI) measurements and did not experience severe headaches directly before or during the fMRI measurements. In particular, patients who had to be replaced due to severe headaches were excluded from the ES.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Amygdala left0.305 Percent changeStandard Deviation 0.119
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Amygdala right0.364 Percent changeStandard Deviation 0.136
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Dorsolateral prefrontal cortex left0.065 Percent changeStandard Deviation 0.146
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Dorsolateral prefrontal cortex right0.131 Percent changeStandard Deviation 0.202
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Insula left0.162 Percent changeStandard Deviation 0.146
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Insula right0.157 Percent changeStandard Deviation 0.133
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Anterior cingulate cortex left0.003 Percent changeStandard Deviation 0.121
Placebo Matching to BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Anterior cingulate cortex right-0.008 Percent changeStandard Deviation 0.131
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Dorsolateral prefrontal cortex left0.044 Percent changeStandard Deviation 0.111
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Anterior cingulate cortex left-0.027 Percent changeStandard Deviation 0.074
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Dorsolateral prefrontal cortex right0.117 Percent changeStandard Deviation 0.183
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Insula left0.110 Percent changeStandard Deviation 0.107
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Insula right0.137 Percent changeStandard Deviation 0.107
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Amygdala left0.290 Percent changeStandard Deviation 0.134
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Amygdala right0.291 Percent changeStandard Deviation 0.146
CitalopramMean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Anterior cingulate cortex right-0.026 Percent changeStandard Deviation 0.087
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Dorsolateral prefrontal cortex left0.049 Percent changeStandard Deviation 0.109
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Amygdala right0.282 Percent changeStandard Deviation 0.071
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Amygdala left0.223 Percent changeStandard Deviation 0.093
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Dorsolateral prefrontal cortex right0.125 Percent changeStandard Deviation 0.105
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Anterior cingulate cortex left-0.024 Percent changeStandard Deviation 0.085
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Insula right0.1205 Percent changeStandard Deviation 0.125
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Insula left0.075 Percent changeStandard Deviation 0.126
BI 1358894Mean Blood Oxygenation Level Depend (BOLD) Signal % Change in an Emotional Paradigm, Based on the Emotional Faces From the Warsaw Set of Emotional Facial Expression Pictures (WSEFEP)Anterior cingulate cortex right-0.018 Percent changeStandard Deviation 0.101
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Rightp-value: 0.879290% CI: [-0.09, 0.07]ANOVA
Comparison: Mean BOLD signal % change/ Amygdala Leftp-value: 0.010590% CI: [-0.14, -0.03]ANOVA
Comparison: Mean BOLD signal % change/ Amygdala Rightp-value: 0.013490% CI: [-0.14, -0.03]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Leftp-value: 0.349590% CI: [-0.08, 0.02]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex rightp-value: 0.700890% CI: [-0.07, 0.04]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Leftp-value: 0.663590% CI: [-0.08, 0.05]ANOVA
Comparison: Mean BOLD signal % change/ Insula Leftp-value: 0.041990% CI: [-0.15, -0.02]ANOVA
Comparison: Mean BOLD signal % change/ Insula Rightp-value: 0.165890% CI: [-0.12, 0.01]ANOVA
Comparison: Mean BOLD Signal % change/ Amygdala Leftp-value: 0.667390% CI: [-0.08, 0.05]ANOVA
Comparison: Mean BOLD Signal % Change/ Amygdala Rightp-value: 0.077890% CI: [-0.14, -0.01]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Leftp-value: 0.325890% CI: [-0.08, 0.02]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Rightp-value: 0.595490% CI: [-0.07, 0.04]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Leftp-value: 0.591190% CI: [-0.08, 0.04]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Rightp-value: 0.828390% CI: [-0.11, 0.08]ANOVA
Comparison: Mean BOLD signal % change/ Insula Leftp-value: 0.179790% CI: [-0.12, 0.01]ANOVA
Comparison: Mean BOLD signal % change/ Insula Rightp-value: 0.577290% CI: [-0.08, 0.04]ANOVA
Secondary

Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).

The secondary endpoint was the mean BOLD signal % change in an emotional paradigm (affective picture set - OASIS task) in the corticolimbic system, consisting of eight brain regions: * Amygdala left * Amygdala right * Dorsolateral prefrontal cortex left * Dorsolateral prefrontal cortex right * Insula left * Insula right * Anterior cingulate cortex left * Anterior cingulate cortex right

Time frame: A 50 min scan, 6 hours following drug intake.

Population: Evaluable set (ES): This patient set included all randomised patients who performed the fMRI measurements and did not experience severe headaches directly before or during the fMRI measurements. In particular, patients who had to be replaced due to severe headaches were excluded from the ES.

ArmMeasureGroupValue (MEAN)Dispersion
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Amygdala left0.231 Percent changeStandard Deviation 0.123
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Amygdala right0.200 Percent changeStandard Deviation 0.125
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Dorsolateral prefrontal cortex left0.269 Percent changeStandard Deviation 0.132
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Dorsolateral prefrontal cortex right0.229 Percent changeStandard Deviation 0.174
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Insula left0.279 Percent changeStandard Deviation 0.132
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Insula right0.195 Percent changeStandard Deviation 0.142
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Anterior cingulate cortex left0.089 Percent changeStandard Deviation 0.1
Placebo Matching to BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Anterior cingulate cortex right0.091 Percent changeStandard Deviation 0.129
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Dorsolateral prefrontal cortex left0.262 Percent changeStandard Deviation 0.178
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Anterior cingulate cortex left0.071 Percent changeStandard Deviation 0.081
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Dorsolateral prefrontal cortex right0.220 Percent changeStandard Deviation 0.116
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Insula left0.270 Percent changeStandard Deviation 0.125
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Insula right0.207 Percent changeStandard Deviation 0.154
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Amygdala left0.185 Percent changeStandard Deviation 0.13
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Amygdala right0.186 Percent changeStandard Deviation 0.13
CitalopramMean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Anterior cingulate cortex right0.082 Percent changeStandard Deviation 0.113
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Dorsolateral prefrontal cortex left0.147 Percent changeStandard Deviation 0.141
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Amygdala right0.132 Percent changeStandard Deviation 0.105
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Amygdala left0.148 Percent changeStandard Deviation 0.1
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Dorsolateral prefrontal cortex right0.155 Percent changeStandard Deviation 0.141
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Anterior cingulate cortex left0.027 Percent changeStandard Deviation 0.11
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Insula right0.120 Percent changeStandard Deviation 0.1
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Insula left0.164 Percent changeStandard Deviation 0.114
BI 1358894Mean BOLD Signal % Change in an Emotional Paradigm in the Corticolimbic System Using the Affective Pictures of the Open Affective Standardised Image Set (OASIS).Anterior cingulate cortex right0.025 Percent changeStandard Deviation 0.104
Comparison: Mean BOLD signal % change/ Amygdala Leftp-value: 0.014790% CI: [-0.14, -0.03]ANOVA
Comparison: Mean BOLD signal % change/ Amygdala Rightp-value: 0.04890% CI: [-0.13, -0.01]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Leftp-value: 0.029490% CI: [-0.12, -0.02]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Rightp-value: 0.035990% CI: [-0.13, -0.02]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Leftp-value: 0.002290% CI: [-0.19, -0.06]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Rightp-value: 0.10490% CI: [-0.15, 0]ANOVA
Comparison: Mean BOLD signal % change/ Insula Leftp-value: 0.002290% CI: [-0.18, -0.06]ANOVA
Comparison: Mean BOLD signal % change/ Insula Rightp-value: 0.033190% CI: [-0.14, -0.02]ANOVA
Comparison: Mean BOLD signal % change/ Amygdala Leftp-value: 0.214990% CI: [-0.11, 0.02]ANOVA
Comparison: Mean BOLD signal % change/ Amygdala Rightp-value: 0.689690% CI: [-0.08, 0.05]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Leftp-value: 0.476990% CI: [-0.06, 0.02]ANOVA
Comparison: Mean BOLD signal % change/ Anterior Cingulate Cortex Rightp-value: 0.76890% CI: [-0.07, 0.05]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Leftp-value: 0.799790% CI: [-0.08, 0.06]ANOVA
Comparison: Mean BOLD signal % change/ Dorsolateral Prefrontal Cortex Rightp-value: 0.833490% CI: [-0.08, 0.06]ANOVA
Comparison: Mean BOLD signal % change/ Insula Leftp-value: 0.740290% CI: [-0.07, 0.05]ANOVA
Comparison: Mean BOLD signal % change/ Insula Rightp-value: 0.81290% CI: [-0.06, 0.08]ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026