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Effects of intranasal insulin on anxiety symptomatology: effects of intranasal insulin application on fear extinction

Effects of intranasal insulin on anxiety symptomatology: effects of intranasal insulin application on fear extinction - FEI

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00010551
Enrollment
80
Registered
2016-06-22
Start date
2016-06-07
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

In the first phase of the study, only healthy subjects are examined.Future studies with patients suffering from anxiety disorders and PTSD might be considered.

Interventions

Group 1: Intranasal insulin (160 IU, single dose) Group 2: Intranasal Placebo (diluting medium for insulin, single dose)

Sponsors

Universität des SaarlandesKlinische Psychologie und Psychotherapie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: - Healthy participants between 18 and 45 years old - Normal weight - For women: regular intake of contraceptives

Exclusion criteria

Exclusion criteria: - Acute or chronic medical/psychiatric problems - Intake of medication (exception: contraceptives; ocassional Aspirin or Paracetamol, last time maximum one week before beginning of the study) - Participation in pharmacological studies in the last 4 weeks - Regular consum of nicotine, alcohol or drugs - Previous traumatic experience or acute depressive feelings - Pregnancy or nursing period - Tinnitus - Diabetes (also from parents and siblings) - Diseases and anatomic deviations of the nose

Design outcomes

Secondary

MeasureTime frame
- Heart rate variability (HRV) and electrodermal response (EDA) assessed during resting state at different points of the experiment - Questionnaires and tests (BDI, STAI-T, SCI, BFI-S, VVM) assessed before the first experimental phase - Questionnaires and subjective ratings (STAI-S, arousal, stress, activation, anxiety and unpleasantness of electroshock) assessed throughout the experiment - Basal cortisol measured on the day of insulin/placebo administration (CAR, Cortisol awakening response) and cortisol levels measured throughout the experiment. - Blood glucose after intranasal insulin/placebo application measured with a blood glucose-monitoring device.

Primary

MeasureTime frame
- Differences in fear extinction and reinstatement between groups (intranasal insulin vs. intranasal placebo) - Paradigm: Differential Fear Conditioning - Measures of interest: Electrodermal response (EDA), startle reaction (EMG of the orbicularis oculi muscle), heart rate (ECG), subjective ratings of the stimulus (contingency awareness, valence, expectancy) measured throughout the experiment.

Countries

Germany

Contacts

Public ContactDiana Ferreira de Sá

Universität des SaarlandesKlinische Psychologie und Psychotherapie

diana.ferreira at uni-saarland.de++49 +681 302 71209

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026