The effects of intranasal oxytocin on emotion processing and carer burden in individuals diagnosed with frontotemporal dementia

Phase 3

Suspended

• Conditions: Frontotemporal Dementia; Emotion Processing; Neurological - Dementias

• Registration Number: ACTRN12618001807246
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-11-06
• Last Update Posted: 19 September 2022

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1.Be within 40 to 75 years of age
2.Have a diagnosis of behavioural variant frontotemporal dementia, semantic dementia, or progressive non-fluent aphasia
3.Have a carer who will be able to live with the participant during the study

Exclusion Criteria

1.Severely compromised cardiac, hepatic or renal function
2.Severe nasal obstruction/blockage
3.Sensitivity to preservatives (in particular benzyl alcohol 0.9%), which are present in the nasal spray formulation
4.Upcoming surgery, due to concerns of interactions with other medications
5.Prior history of psychiatric disorders (e.g. major depression, schizophrenia, bipolar disorder)
6.Prescribed an anticholinesterase medication for less than three months or are experiencing side effects secondary to this class of medication.
7.Have prior history of neurological disorder other than dementia (e.g., head injury, stroke or transient ischemic attack, epilepsy)
8.Have a diagnosis of another neurodegenerative disease (e.g., Dementia with Lewy Bodies, Alzheimer’s Disease, Parkinson’ Disease)
9.Have an intellectual disability
10. Have a current history of substance abuse

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Performance on The Awareness of Social Inference Test (TASIT) following placebo and active drug intervention phases in comparison to baseline. The TASIT is a video-based assessment of social cognition and basic emotion recognition. [Pre single-dose administration (Visit 0), One week post-intervention (Visit 2 and Visit 4)];Difference in scoring on the Cambridge Behavioural Inventory (CBI) following placebo and active drug intervention phases in comparison to baseline. The CBI is an informant-based questionnaire used to differentiate neurodegenerative syndromes across ten behavioural domains such as memory, mood, eating habits, sleep etc. [Pre single-dose administration (Visit 0), One week post-intervention (Visit 2 and Visit 4)]