Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000528257
Ethics application status
Approved
Date submitted
26/06/2009
Date registered
2/07/2009
Date last updated
5/11/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of Oxytocin (OT) on social cogntion in Schizophrenia.
Scientific title
The impact of oxytocin in Schizophrenia to treat social communication problems.
Secondary ID [1] 283521 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Schizophrenia 4872 0
Condition category
Condition code
Mental Health 237429 237429 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Adults with a primary diagnosis of Schizophrenia are given a single dose (24 International Units) of oxytocin nasal spray or an identical placebo in a crossover design with one-week washout period. Participants receive the nasal spray, wait 45 minutes and complete experimental tasks. Participants return one week later to receive the nasal spray again, wait 45 minutes and complete the same experimental tasks. On both occasions participants are observed for a period of 1.5 hours while they complete social cognition tasks. These tasks include emotion recognition (Reading the mind in the eyes (RMET) and the Penn Emotion Recognition Test (PERT)), eye-tracking when viewing human faces, and assessing comprehension of potential threats when viewing videos of social events. The entire trial is completed within these two experimental testing sessions.
Intervention code [1] 236822 0
Treatment: Drugs
Comparator / control treatment
The placebo nasal spray is a solution containing all of the ingredients used in the OT nasal spray except the active OT. It is administered 45 minutes before participants complete experimental cognition tasks. The placebo is administered in exactly the same manner as the OT spray. All participants receive 24 International Units.
Control group
Placebo

Outcomes
Primary outcome [1] 238229 0
Performance on Reading the Mind in the Eyes Test
Timepoint [1] 238229 0
45 minutes post drug administration at week 1 and at week 2 drug administration.
Secondary outcome [1] 242199 0
Eye-gaze duration and fixation as assessed by a Tobii Eye Tracker when viewing faces
Timepoint [1] 242199 0
45 minutes post drug administration at week 1 and at week 2 drug administration.
Secondary outcome [2] 242205 0
Performance on the Facial Expressions of Emotions (FEEST)
Timepoint [2] 242205 0
45 minutes post drug administration at week 1 and at week 2 drug administration.
Secondary outcome [3] 242206 0
Performance on the False-Belief Picture Sequencing Task
Timepoint [3] 242206 0
45 minutes post drug administration at week 1 and at week 2 drug administration.
Secondary outcome [4] 242207 0
Performance on the Hinting Task
Timepoint [4] 242207 0
45 minutes post drug administration at week 1 and at week 2 drug administration.
Secondary outcome [5] 244560 0
Performance on the Internal, Personal and Situational Attributions Questionnaire
Timepoint [5] 244560 0
45 minutes post drug administration at week 1 and at week 2 drug administration.
Secondary outcome [6] 244561 0
Performance on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Timepoint [6] 244561 0
45 minutes post drug administration at week 1 and at week 2 drug administration.

Eligibility
Key inclusion criteria
Adult males with a primary diagnosis of schizophrenia as determined by interview on the Diagnostic INterview for Psychoses (DIP) and symptoms as assessed by the Positive and Negative Syndrome Scale (PANSS)
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they meet Diagnostic and Statistical Manual
of Mental Disorders (DSM-IV) criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months, have medical conditions that preclude participation in drug trials (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders) and if their Intelligence Quotient (IQ) falls below 75. Participants must be stabilised on medication for a period of 8 weeks. No females are included in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Drug allocation concealment is conducted by numbering all containers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number generation using computer software. Each number is labelled with 'a' or 'b' where a or b could represent either Oxytocin or Placebo in a cross-over design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
All participants, assessors, therapists, and data entry staff are blind to drug condition.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/06/2009
Actual
26/08/2009
Date of last participant enrolment
Anticipated
Actual
21/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 237212 0
Self funded/Unfunded
Name [1] 237212 0
Adam Guastella
Country [1] 237212 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
94 Mallett St Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 4707 0
None
Name [1] 4707 0
Address [1] 4707 0
Country [1] 4707 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239313 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 239313 0
Ethics committee country [1] 239313 0
Australia
Date submitted for ethics approval [1] 239313 0
Approval date [1] 239313 0
05/03/2009
Ethics approval number [1] 239313 0
11268

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29661 0
A/Prof Adam Guastella
Address 29661 0
Brain & Mind Research Institute The University of Sydney 94 Mallett St Camperdown NSW 2050
Country 29661 0
Australia
Phone 29661 0
+61 2 9351 0539
Fax 29661 0
Email 29661 0
[email protected]
Contact person for public queries
Name 12908 0
Adam Guastella
Address 12908 0
Brain & Mind Research Institute
The University of Sydney
100 Mallett St Camperdown NSW 2050
Country 12908 0
Australia
Phone 12908 0
+61 2 9351 0539
Fax 12908 0
Email 12908 0
[email protected]
Contact person for scientific queries
Name 3836 0
Adam Guastella
Address 3836 0
Brain & Mind Research Institute
The University of Sydney
100 Mallett St Camperdown NSW 2050
Country 3836 0
Australia
Phone 3836 0
+61 2 9351 0539
Fax 3836 0
Email 3836 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseA single dose of oxytocin nasal spray improves higher-order social cognition in schizophrenia.2015https://dx.doi.org/10.1016/j.schres.2015.06.005
N.B. These documents automatically identified may not have been verified by the study sponsor.