Oxytocin and CBSST for People With Schizophrenia
A significant proportion of people with schizophrenia are characterized by impaired ability to socially engage with others, which may reflect social aversion secondary to defeatist beliefs; decreased motivation for social interactions; and/or impairment in the normal reinforcement value of social interactions. These impairments in social function have been shown to be associated with social skill deficits; and decreased ability to identify and remember emotional facial expressions and empathize with the emotional status of others. Unfortunately, pharmacological interventions have limited benefits for impaired social function, whereas psychosocial interventions provide only partial benefit for this critical aspect of the illness. The development of an effective intervention for functional outcomes remains a central therapeutic challenge. Cognitive Behavioral Social Skills Training (CBSST) uses corrective feedback and reinforcement provided by successful interactions to challenge and reduce defeatist performance beliefs that contribute to low drive and interfere with social functioning. CBSST has been shown to have modest effects on social function in people with schizophrenia. Oxytocin plays a critical role in the regulation of normal social affiliative behavior; it is hypothesized to enhance social affiliation through the reduction of anxiety or social risk aversion; the enhancement of motivation for prosocial approach behavior; and/or increased modulation of the salience and processing of social cues. People with schizophrenia have decreased oxytocin levels, which are associated with an impaired ability to identify facial emotions and decreased prosocial behaviors. The study will be comprised of three phases: 1) 2-week Evaluation Phase; 2) 24-week Double-blind Treatment Phase; and 3) 3-month Follow-up Phase.
Drug: CBSST + Oxytocin
Drug: CBSST + Placebo
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Combined Oxytocin and CBSST for Social Function in People With Schizophrenia|
- Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. [ Time Frame: 3 years ] [ Designated as safety issue: No ]Efficacy
- Determine if CBSST + oxytocin compared to CBSST + placebo is associated with increased incidence of side effects. [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Determine if CBSST + oxytocin compared to CBSST + placebo is associated with reduced social aversion, including social disinterest and defeatist performance beliefs; increased ability to trust others; and/or improved performance on facial recognition and [ Time Frame: 3 years ] [ Designated as safety issue: No ]Change Mechanism
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: CBSST + oxytocin
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment. Participants will receive 80 IU/day of oxytocin administered intranasally in two doses (40 IU morning and evening).
Drug: CBSST + Oxytocin
The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
Placebo Comparator: CBSST + placebo
Cognitive Behavioral Social Skills Training with placebo nasal spray. The placebo nasal spray bottles will be matched in appearance to the oxytocin nasal spray bottles and similarly administered intranasally in two doses (morning and evening).
Drug: CBSST + Placebo
Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
Other Name: sugar pill
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01752712
|Contact: Jennifer Osingemail@example.com|
|United States, Maryland|
|Maryland Psychiatric Research Center||Recruiting|
|Baltimore, Maryland, United States, 21228|
|Contact: Chris Brown 410-402-7878 Cbrown@mprc.umaryland.edu|
|Contact: Jennifer Osing 410-402-6060 firstname.lastname@example.org|
|Principal Investigator: Robert W. Buchanan, M.D.|
|Principal Investigator:||Robert Buchanan, MD||University of Maryland|