Panic DisorderBINCAPNCT06145490
Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance and Interoception in Healthy Individuals and Panic Disorder.
A study testing Caffeine in people with Panic Disorder and Healthy, run by Uppsala University at 2 sites in Sweden.
Trial summary
The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including Healthy Controls (HC) and participants with Panic Disorder (PD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Panic Disorder, Healthy
- What is being tested?
- Caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesSweden
- Study dates
- 29 Oct 2024to 15 May 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Panic Disorder group (PD): Primary diagnosis of Panic Disorder.
- Healthy control group (HCs): No current or history of psychiatric disorders.
- All participants (PD and HCs): Weekly caffeine consumption ≤ 300 mg.
Who cannot join
- Weekly caffeine consumption ≥ 300 mg.
- Thoracic or head surgery, or any other surgery or metallic implanted devices not compatible with the safety standards for 7T MR scanner.
- History of severe psychiatric disorder (e.g., schizophrenia).
- Somatic or neurological conditions (e.g., hypertension and heart condition).
- Ongoing treatment with psychotropic medication or treatment with psychotropic medication which has been discontinued within 2 months.
- Other ongoing treatments that may confound the results.
Show all 10Show fewer
- Current drug or alcohol abuse/dependency.
- Habitual nicotine use.
- Uncorrected visual or hearing impairment.
- Pregnancy.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
National 7T Facility - Lunds universitet
Lund
Uppsala University, Department of Medical Sciences, Psychiatry
Uppsala, 75185
About this study
Official title: Adenosine Receptors From Genes to Behavior: Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance, Decision-Making and Interoception in Healthy Individuals and Panic Disorder.
The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including Healthy Controls (HC) and participants with Panic Disorder (PD).
The primary aim of the study is to investigate the neural correlates and behavioral effects of caffeine (versus placebo), and its impact on emotional reactivity, decision-making, and interoception, and compare the effects in individuals with PD vs HCs. Subjective anxiety and the occurrence of panic attacks will also be measured. Multimodal neuroimaging methods, such as structural and functional MRI, will be used to address the aims of the study.
Read more
Emotional reactivity, emotional decision-making and interoception will be measured with experimental tasks in a 7 Tesla (7T) magnetic resonance (MR) scanner, jointly with measures of skin conductance, heart rate, respiratory rate, and self-reported ratings of anxiety and interoception.
Emotional reactivity will be assessed using emotional and neutral faces. Emotional decision-making will be assessed with an approach-avoidance conflict task. Changes in interoception (bodily sensation, such as pulse and respiration) will be explored using a task in which participants are asked to focus on their breathing or an external stimulus. Caffeine effects on brain resting-state activity will also be assessed. All tasks will be conducted while in the 7T MR scanner.
A secondary aim of the study is to examine the impact of genetic variability in the adenosine A2A receptor (ADORA2A) genotype (e.g., rs5751876 T/T) on the effects of caffeine (vs placebo), as ADORA2A genotype has previously been associated with elevated caffeine-induced anxiety.
Read the detailed description
Given the novelty of the intended study and the lack of previous neuroimaging and emotion-related behavioral studies on caffeine effects in HCs and PD, analyses will be exploratory without directed hypotheses.
It is intended to conduct between-group analyses (HCs vs PD) in the two conditions (caffeine versus placebo), as well as within-group analyses in HCs and PD separately. Between-group analyses will also be conducted between individuals with different ADORA2A genotypes.
- Conditions
- Panic Disorder, Healthy
- Being tested
- Caffeine, Placebo
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
Caffeine capsule 250 mg, oral intake
PlaceboDrug
Placebo capsule, oral intake
| Study group | Role | What they receive |
|---|---|---|
| Panic Disorder | Other | Participants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1). Receives: Dietary Supplement: Caffeine; Drug: Placebo |
| Healthy controls | Other | Participants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1). Receives: Dietary Supplement: Caffeine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Task-related BOLD fMRI signal
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Measured: Session 1 (day 1)
Task-related BOLD fMRI signal
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Self-reported anxiety
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Measured: Session 1 (day 1)
Self-reported anxiety
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Self-reported interoceptive awareness
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Measured: Session 1 (day 1)
Self-reported interoceptive awareness
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Self-reported interoceptive functional impairment
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Measured: Session 1 (day 1)
Self-reported interoceptive functional impairment
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Skin conductance responses (SCR)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Measured: Session 1 (day 1)
Skin conductance responses (SCR)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Occurrence of panic attacks
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
Measured: Session 1 (day 1)
Occurrence of panic attacks
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Secondary outcomes (6)
Structural brain data, T1-w sMRI
Structural brain changes will be analyzed through T1-weighted sMRI (structural magnetic resonance imaging).
Measured: Session 1 (day 1)
Structural brain data, T1-w sMRI
Structural brain changes will be analyzed through T1-weighted sMRI (structural magnetic resonance imaging).
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Heart rate variability
Heart rate variability (HRV) will be assessed by using a 7T MR-compatible heart rate band, during the whole MR scanner time.
Measured: Session 1 (day 1)
Heart rate variability
Heart rate variability (HRV) will be assessed by using a 7T MR-compatible heart rate band, during the whole MR scanner time.
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Respiratory rate
Respiratory or breathing rates will be assessed during the whole MR scanner time.
Measured: Session 1 (day 1)
Respiratory rate
Respiratory or breathing rates will be assessed during the whole MR scanner time.
Measured: Session 2 (day 2; minimum of 36 hours after session/day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start29 Oct 2024
- Primary completion15 May 2025
- Study completion15 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Model description
- The study entails two sessions with a cross-over design. Participants will be randomized to start with either the caffeine condition or the placebo condition. The study includes two arms: (a) participants with Panic Disorder (anticipated n = 50) and (b) Healthy controls (anticipated n = 50). Both arms (Panic Disorder and Healthy controls) will complete both conditions with the two sessions (caffeine and placebo condition) in randomized order.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas Frick, PhD, Principal investigator, Uppsala University, Department of Medical Sciences, Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145490
- Sponsor's protocol ID
- 2023-02915-02
- Other IDs
- 2023
- Acronym
- BINCAP
- Status last verified
- Feb 2026
- First submitted
- 17 Nov 2023
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adenosine Receptors From Genes to Behavior: Neurobehavioral Correlates of Caffeine on Anxiety, Avoidance, Decision-Making and Interoception in Healthy Individuals and Panic Disorder.
- ClinicalTrials.gov ID
- NCT06145490
- Acronym / sponsor ID
- BINCAP / 2023-02915-02
- Conditions
- Panic Disorder, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 15 May 2025 (actual)
- First posted
- 24 Nov 2023 (actual)
- 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.
The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including Healthy Controls (HC) and participants with Panic Disorder (PD).
The primary aim of the study is to investigate the neural correlates and behavioral effects of caffeine (versus placebo), and its impact on emotional reactivity, decision-making, and interoception, and compare the effects in individuals with PD vs HCs. Subjective anxiety and the occurrence of panic attacks will also be measured. Multimodal neuroimaging methods, such as structural and functional MRI, will be used to address the aims of the study.
Emotional reactivity, emotional decision-making and interoception will be measured with experimental tasks in a 7 Tesla (7T) magnetic resonance (MR) scanner, jointly with measures of skin conductance, heart rate, respiratory rate, and self-reported ratings of anxiety and interoception.
Emotional reactivity will be assessed using emotional and neutral faces. Emotional decision-making will be assessed with an approach-avoidance conflict task. Changes in interoception (bodily sensation, such as pulse and respiration) will be explored using a task in which participants are asked to focus on their breathing or an external stimulus. Caffeine effects on brain resting-state activity will also be assessed. All tasks will be conducted while in the 7T MR scanner.
A secondary aim of the study is to examine the impact of genetic variability in the adenosine A2A receptor (ADORA2A) genotype (e.g., rs5751876 T/T) on the effects of caffeine (vs placebo), as ADORA2A genotype has previously been associated with elevated caffeine-induced anxiety.
Detailed description
Given the novelty of the intended study and the lack of previous neuroimaging and emotion-related behavioral studies on caffeine effects in HCs and PD, analyses will be exploratory without directed hypotheses.
It is intended to conduct between-group analyses (HCs vs PD) in the two conditions (caffeine versus placebo), as well as within-group analyses in HCs and PD separately. Between-group analyses will also be conducted between individuals with different ADORA2A genotypes.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The study entails two sessions with a cross-over design. Participants will be randomized to start with either the caffeine condition or the placebo condition. The study includes two arms: (a) participants with Panic Disorder (anticipated n = 50) and (b) Healthy controls (anticipated n = 50). Both arms (Panic Disorder and Healthy controls) will complete both conditions with the two sessions (caffeine and placebo condition) in randomized order.
| Arm | Type | Receives |
|---|---|---|
| Panic Disorder | Other | Dietary Supplement: Caffeine, Drug: PlaceboParticipants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1). |
| Healthy controls | Other | Dietary Supplement: Caffeine, Drug: PlaceboParticipants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Panic Disorder group (PD): Primary diagnosis of Panic Disorder.
- Healthy control group (HCs): No current or history of psychiatric disorders.
- All participants (PD and HCs): Weekly caffeine consumption ≤ 300 mg.
Key exclusion criteria (10 listed)
- Weekly caffeine consumption ≥ 300 mg.
- Thoracic or head surgery, or any other surgery or metallic implanted devices not compatible with the safety standards for 7T MR scanner.
- History of severe psychiatric disorder (e.g., schizophrenia).
- Somatic or neurological conditions (e.g., hypertension and heart condition).
- Ongoing treatment with psychotropic medication or treatment with psychotropic medication which has been discontinued within 2 months.
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 |
|---|---|---|
| CaffeineCaffeine capsule 250 mg, oral intake | Dietary supplement | Healthy controls, Panic Disorder |
| PlaceboPlacebo capsule, oral intake | Drug | Healthy controls, Panic Disorder |
Primary outcome
Task-related BOLD fMRI signal
Time frame: Session 1 (day 1)
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Task-related BOLD fMRI signal
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Task-related BOLD (blood-oxygen-level-dependent) fMRI (functional magnetic resonance imaging) signal will be collected through a 7T MR scanner, starting approximately 30 minutes after oral intake of caffeine or placebo pill. Tasks: Emotional reactivity, Approach-Avoidance Conflict Task, Interoception, Resting-state fMRI.
Self-reported anxiety
Time frame: Session 1 (day 1)
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Self-reported anxiety
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Anxiety will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task measured with self-reported ratings, on a scale from 0-100 (0= no anxiety - 100= extreme anxiety).
Self-reported interoceptive awareness
Time frame: Session 1 (day 1)
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Self-reported interoceptive awareness
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Interoceptive awareness will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task in the MR scanner, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no awareness - 100= extreme awareness).
Self-reported interoceptive functional impairment
Time frame: Session 1 (day 1)
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Self-reported interoceptive functional impairment
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Interoceptive functional impairment will be assessed before capsule intake (either caffeine or placebo), 20 minutes after intake, after each task, and during the interoception task, measured with self-reported ratings on a scale from 0-100 (0= no impairment - 100= extreme impairment).
Skin conductance responses (SCR)
Time frame: Session 1 (day 1)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Skin conductance responses (SCR)
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Skin conductance responses will be used to assess emotional reactivity at the physiological level to emotional stimuli vs neutral stimuli (faces).
Occurrence of panic attacks
Time frame: Session 1 (day 1)
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
Occurrence of panic attacks
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
The occurrence of panic attacks will be assessed according to the Diagnostic Statistical Manual (DSM-5) criteria for panic attacks and will be coded dichotomous as "present" or "not present".
6 secondary outcomes
Structural brain data, T1-w sMRI
Time frame: Session 1 (day 1)
Structural brain data, T1-w sMRI
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Heart rate variability
Time frame: Session 1 (day 1)
Heart rate variability
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Respiratory rate
Time frame: Session 1 (day 1)
Respiratory rate
Time frame: Session 2 (day 2; minimum of 36 hours after session/day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
Andreas Frick, PhD principal investigator
Uppsala University, Department of Medical Sciences, Psychiatry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine in people with Panic Disorder and Healthy, run by Uppsala University at 2 sites in Sweden.
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 3 inclusion and 10 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: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Task-related BOLD fMRI signal (time frame: Session 1 (day 1)). The study lists 12 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 27 Feb 2026.