Resting-state Connectivity and Individual Differences in Affective Placebo Responsiveness

NCT07479966 | Enrolling By Invitation

• 2 other identifiers: Z03-ReCAPProject Number 422744262 (Z03)
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Expectation effects on affective states are central to mechanisms relevant for mood disorders and their treatment. This study will test whether inter-individual differences in resting-state functional connectivity (rsFC) within emotion regulation networks is associated with affective placebo responsiveness in healthy volunteers. Approximately 50 healthy participants will be pooled from two cross-over placebo studies in which participants receive intranasal saline either labeled as "oxytocin" in the placebo condition or as saline in the control condition. Primary indices of placebo responsiveness are placebo-control difference scores of mood state, emotional paradigm responses, as well as expectation and experience ratings. rsFC will be estimated using the CONN toolbox. Confirmatory analyses will use an a priori seed-based approach, with prefrontal seeds derived from previous task-based fMRI findings on affective placebo effects. These analyses will be complemented by secondary summaries of within- and between-network connectivity across the saliency network, the fronto-parietal control network, and the default mode network. We hypothesize that interindividual differences in target rsFC networks will be associated with affective placebo effects, indicating general, trait-like mechanisms of placebo responsiveness.

Conditions

Condition: Healthy

Outcome Measures

Primary Outcomes (1)

• Resting-state functional connectivity measures in prefrontal-emotion-related circuitry

  Resting-state fMRI will be used to estimate Fisher r-to-z transformed functional connectivity using seed-based and ROI-to-ROI analyses within prefrontal-emotion-related circuitry. These rsFC measures will be tested for associations with participant-level placebo-response indices derived from prior placebo/control sessions.

  During one separate post-paradigm MRI session lasting approximately 45 minutes, after completion of the preceding placebo study protocol.

Secondary Outcomes (1)

• Within-network and between-network resting-state functional connectivity across canonical large-scale networks

  During one separate post-paradigm MRI session lasting approximately 45 minutes, after completion of the preceding placebo study protocol.

Study Arms (1)

Healthy volunteers

This rs-fMRI study will include healthy volunteers who completed an expectation-manipulation study and agreed to an additional rs-fMRI session. The sample will be drawn from the ongoing ClinicalTrials.gov-registered study "Expectation Effects on Emotional Processing" (NCT07031804) (Szabo et al., in prep) and a previously collected cohort reported by Mostauli et al. (2025).

Other: No intervention

Interventions

No intervention OTHER

No intervention

Healthy volunteers

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

This rs-fMRI study will include healthy volunteers who completed an expectation-manipulation study and agreed to an additional rs-fMRI session. The sample will be drawn from the ongoing ClinicalTrials.gov-registered study "Expectation Effects on Emotional Processing" (NCT07031804) (Szabo et al., in prep) and a previously collected cohort reported by Mostauli et al. (2025). In both datasets, participants complete a counterbalanced cross-over fMRI design with sessions approximately one week apart, receiving intranasal saline labeled as "oxytocin" or "saline". In the scanner, participants perform an emotion classification task (Szabo et al., in prep.) or a spatial cueing task with emotional distractors (Mostauli et al., 2025). After finishing the study, participants are invited to an additional MRI session including resting-state fMRI and a T1-weighted scan.

You may qualify if:

• Aged 18-35 years
• MRI compatible
• Medical information and signed declaration of consent
• Normal or corrected to normal vision
• German speaking

You may not qualify if:

• No informed consent
• Current intake of central nervous system active drugs
• Under influence of alcohol
• BDI score above 12
• Significant acute somatic or neurological diseases
• History of psychiatric or neurological disorders
• Pregnancy/ breastfeeding
• Acute nasal diseases or injuries
• fMRI data with strong artefacts or excessive movement will be excluded from analysis

Sponsors & Collaborators

• Stefanie Brassen: lead

Study Sites (1)

Department of Systems Neuroscience, University Medical Center Hamburg-Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

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Related Links

• Szabo et al., in preperation; Expectation Effects on Emotional Processing ClinicalTrials.gov ID NCT07031804

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: March 27, 2022
• Primary Completion: May 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

DE (1)