Effects of Caffeine on Anxiety, Emotional Processing, Approach-avoidance Behavior, and Interoception in Panic Disorder

NCT05261594 | Completed

• 1 other identifier: 2019-06451
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

The current study is a placebo-controlled, double-blind, randomized controlled study using a cross-over design, including participants with Panic disorder and healthy controls. The study's primary aim is to investigate the effects of caffeine (vs placebo) on self-reported anxiety and its impact on emotional reactivity and goal-directed behavior in individuals with Panic disorder (vs healthy controls). Emotional reactivity will be measured with self-reported emotions and skin conductance responses. Caffeine-induced effects on goal-directed behavior will be assessed using an approach-avoidance conflict paradigm and an effort-allocation task. The occurrence of panic attacks and panic-related symptoms will also be measured. Furthermore, the link between a genotype of ADORA2A (rs5751876 T/T) previously associated with caffeine-induced anxiety, and the anxiogenic effects of caffeine will also be explored. In addition, caffeine-induced changes in attention to interoceptive stimuli (bodily sensation such as pulse and respiration) and anxiety elicited by attention to interoceptive stimuli will be explored. A secondary aim is to examine the potential caffeine-induced effects and the impact of genetic variation in healthy participants (caffeine vs placebo).

Conditions

Panic Disorder; Healthy

Outcome Measures

Primary Outcomes (2)

• Self-reported anxiety

  Anxiety will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=no anxiety - 100=extreme anxiety).

  Session 1 (day 1)

• Self-reported anxiety

  Anxiety will be assessed before capsule (caffeine/placebo) intake, 30 minutes after intake during rest, and after each task with self-reported ratings on a scale from 0-100 (0=no anxiety - 100=extreme anxiety).

  Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

Secondary Outcomes (16)

• Self-reported emotions

  Session 1 (day 1)

• Self-reported emotions

  Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

• Skin conductance responses (SCR)

  Session 1 (day 1)

• Skin conductance responses (SCR)

  Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

• Approach-avoidance behavior

  Session 1 (day 1)

Other Outcomes (8)

• Expectancy ratings

  Session 1 (day 1)

• Expectancy ratings

  Session 2 (minimum of 36 hours after Session 1 (day 1) maximum of 14 days after Session 1 (day 1))

• Panic Disorder Severity Scale (PDSS)

  1-7 days prior to session 1 (internet)

Study Arms (2)

Panic disorder

OTHER

Participants will be randomized to start with either the caffeine condition or placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).

Dietary Supplement: Caffeine; Drug: Placebo

Healthy controls

OTHER

Participants will be randomized to start with either the caffeine condition or placebo condition. Participants will complete session 2 with the other condition (condition not allocated to in session 1).

Dietary Supplement: Caffeine; Drug: Placebo

Interventions

Caffeine DIETARY_SUPPLEMENT

Caffeine capsule 150 mg, oral intake

Healthy controls; Panic disorder

Placebo DRUG

Placebo capsule, oral intake

Healthy controls; Panic disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Panic disorder group: Primary diagnosis of panic disorder.
• Healthy control group: No current or history of psychiatric disorders.
• All participants (Panic disorder and healthy): Weekly caffeine consumption ≤ 300 mg.

You may not qualify if:

• 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. Current drug or alcohol abuse/dependency. Habitual nicotine use. Uncorrected visual or hearing impairment. Pregnancy.

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Uppsala university, Department of Medical Sciences, Psychiatry

Uppsala, 75185, Sweden

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Caffeine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Andreas Frick, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study entails two sessions and uses a crossover design. Participants will be randomized to start with either the caffeine condition or the placebo condition. Participants will complete the second session with the other condition (the condition not allocated to in session 1). The study includes two arms: (a) participants with Panic disorder (estimated n=50; actual n=30) and (b) healthy controls (estimated n=50; actual n=53). Both arms (Panic disorder and healthy controls) will complete both conditions (caffeine and placebo condition) in randomized order.

Study Record Dates

• First Submitted: January 26, 2022
• First Posted: March 2, 2022
• Study Start: March 16, 2022
• Primary Completion: March 19, 2023
• Study Completion: March 19, 2023
• Last Updated: April 19, 2023

Record last verified: 2023-04

Locations

SE (1)