Oxytocin as Adjunctive Treatment of Schizophrenia
The focus of the current project is to advance our understanding of the effects of oxytocin (OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in our understanding of the role of OT in rodent models of social behavior and an explosion of interest in the prosocial effects of OT in healthy controls, little work has been done to dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits are a crucial aspect of the functional impairments that limit the rehabilitation of patients with SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome, Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of the illness. Our currently available medications do very little to improve these social deficits. Hence it is of utmost public health importance to address the knowledge gap regarding the potential of OT to improve social function in this illness. Intact social function depends on the competent functioning of several cognitive domains that subserve perception of social cues and the generation of motivated social behavior. We propose to conduct a pharmacological challenge study of OT vs. placebo administration to study the effects of OT on specific components of social cognition in male deficit syndrome SCZ subjects.
Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit syndrome SCZ.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Oxytocin as Adjunctive Treatment of Schizophrenia|
- eye tracking [ Time Frame: within two hours after administration of oxytocin vs. placebo ] [ Designated as safety issue: No ]In order to assess the processing of social stimuli, subjects will be presented with a series of human faces of mixed sex and race showing neutral emotions and instructed to visually scan each face. Six regions of interest (ROIs) will be defined for each face stimulus: eyes, nose mouth, forehead, cheeks, and outside the contours of the face. The data will be processed off line for each face stimulus as the total time of fixation inside each of the ROIs. The initial analysis will compare time spent by subjects after oxytocin vs. placebo looking at the ROIs within vs. outside the facial contours.
- Social reward ball-tossing task [ Time Frame: within two hours after administration of oxytocin vs. placebo ] [ Designated as safety issue: No ]Subjects will perform a computerized Social Reward Ball-Tossing Task in which they decide to return the ball to one of three fictional partners. The photos of the partners and their reciprocity in returning the ball to the subject will be manipulated. These trials will be interleaved with non-social trials where subjects will play with random geometric shapes or landscape scenes associated with positive and negative non-social rewards. The number of balls sent to each of the partners will be quantified to assess socially reinforced learning. These measures will be compared between the oxytocin and placebo group.
- Facial Emotion Identification Task [ Time Frame: within two hours after administration of oxytocin vs. placebo ] [ Designated as safety issue: No ]The stimuli are 19 standard black and white pictures of faces showing one of six different emotions (happy, sad, angry, surprise, disgusted, ashamed) that were developed by Ekman and Friesen (1976). The pictures are shown for 15 sec, with 10 sec between each face. After the presentation of each face the subject is asked to choose which of the six emotions was displayed. The score on the test is the sum of correct responses. Subjects in the two groups (oxytocin vs. placebo) will be compared.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||January 2018|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
The intranasal oxytocin intervention will be the administration of OT intranasally at a dose of three 4 IU puffs per nostril for a total dose of 24 IU. Each puff is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally. This dose has been used in a number of other similarly designed challenge studies examining the effects of a single dose of OT (Kirsch et al. 2005; Kosfeld et al. 2005; Guastella et al. 2008a; Guastella et al. 2008b; Rimmele et al. 2009; Andari et al. 2010).
OT intervention will be administration of OT intranasally at a dose of three 4 IU puffs per nostril for a total dose of 24 IU. This dose has been used in a number of other similarly designed challenge studies examining the effects of a single dose of OT (Kirsch et al. 2005; Kosfeld et al. 2005; Guastella et al. 2008a; Guastella et al. 2008b; Rimmele et al. 2009; Andari et al. 2010).
Other Name: Syntocinon
Placebo Comparator: Placebo
Intranasal placebo The PBO/control will consist of the OT vehicle administered as three puffs in each nostril. Each puff is is 0.1ml in volume so the total volume administered will be 0.6 ml intranasally.
Treatment assignment will be by random allocation in blocks of six. Both experimenters and subjects will be blind to the treatment they are receiving.
The PBO/control will consist of the OT vehicle only delivered as 3 puffs of saline per nostril for a total of 6 puffs. Each puff contains 0.1 ml in volume, so the total delivered will be 0.6 ml intranasally.
Other Name: Inactive vehicle
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01568528
|Contact: Molly Fargotstein, BA||404-321-6111 ext firstname.lastname@example.org|
|Contact: Erica J Duncan, MD||404-321-6111 ext email@example.com|
|United States, Georgia|
|Atlanta VA Medical Center||Recruiting|
|Decatur, Georgia, United States, 30033|
|Contact: Molly Fargotstein, BA 404-321-6111 ext 6967 firstname.lastname@example.org|
|Contact: Erica J Duncan, MD 404-321-6111 ext 7532 email@example.com|
|Principal Investigator: Erica J Duncan, MD|
|Principal Investigator:||Erica J Duncan, MD||Emory University|