Oxytocin and CBSST for People With Schizophrenia
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Purpose
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 addition of oxytocin to CBSST is hypothesized to: 1) enhance the reduction of defeatist performance beliefs by reducing social risk aversiveness and avoidance; 2) enhance social skill acquisition through improvement of proximal social behaviors; and 3) facilitate the translation of learned social skills into community practice through its effects on prosocial attachment behaviors and reduction in social disinterest. The investigators will conduct a 24-week, double-blind, placebo-controlled, RCT with a 3-month follow-up evaluation. The primary aim of the study is to collect preliminary data on the efficacy of combined CBSST + oxytocin for social function in schizophrenia. Secondary aims include the examination of the safety and acceptability of the proposed intervention. The investigators will also examine whether the effects of the proposed intervention are mediated by reduced defeatist performance beliefs; increased ability to trust others; and/or improved performance on measures of facial recognition and memory. Finally, in an exploratory framework, the investigators will examine the effects of the proposed intervention on symptoms, neuropsychological test performance, and global clinical improvement.
| Condition | Intervention |
|---|---|
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Cognitive Behavioral Social Skills Training + Oxytocin Cognitive Behavioral Social Skills Training + Placebo |
Drug: CBSST with Oxytocin Drug: CBSST with Placebo |
| Study Type: | Interventional |
| 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
| Estimated Enrollment: | 60 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Cognitive Behavioral Social Skills Training + oxytocin
Cognitive Behavioral Social Skills Training with adjunct oxytocin nasal spray treatment
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Drug: CBSST with 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)
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Placebo Comparator: Cognitive Behavioral Social Skills Training + placebo
Cognitive Behavioral Social Skills Training with placebo nasal spray
|
Drug: CBSST with Placebo
Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration);
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- DSM-IV-TR diagnosis of schizophrenia
- Scale for the Assessment of Negative Symptoms asociality item score ≥ 2
- Considered clinically stable by the treating psychiatrist
- Stable treatment with the same antipsychotic for at least 60 days and the same dose for at least the 30 days prior to study entry.
Exclusion Criteria:
- Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, loss of consciousness (LOC) for more than 30 minutes
- Mental retardation
- Medical conditions, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol
- Participant is pregnant or is lactating
- History of chronic allergic rhinitis
- DSM-IV-TR diagnosis of alcohol or substance dependence (except nicotine) within the last 6 months, or participant has met dependence criteria for 5 years or more.
- DSM-IV-TR diagnosis of alcohol or substance abuse (except nicotine) within the last month
- Participant has a past history of polydypsic hyponatremia (defined by sodium levels below 130 mmol/L) or has a current sodium level below 135 mmol/L
- Participant with EKG evidence of any of the following cardiac arrhythmias: QTc prolongation (Males: 450 msec or greater; females: 470 msec or greater); atrial fibrillation; ventricular or supraventricular tachycardia; and 2nd or 3rd degree A-V Block
Contacts and Locations| Contact: Jennifer Osing | 410-402-6060 | josing@mprc.umaryland.edu |
| United States, Maryland | |
| Maryland Psychiatric Research Center | Not yet recruiting |
| Baltimore, Maryland, United States, 21228 | |
| Contact: Chris Brown 410-402-7878 Cbrown@mprc.umaryland.edu | |
| Contact: Jennifer Osing 410-402-6060 josing@mprc.umaryland.edu | |
| Principal Investigator: | Robert Buchanan, MD | University of Maryland |
More Information
No publications provided
| Responsible Party: | Robert W. Buchanan, M.D., Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland |
| ClinicalTrials.gov Identifier: | NCT01752712 History of Changes |
| Other Study ID Numbers: | HP-00054628 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 18, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Maryland:
|
Oxytocin Social function CBSST |
Additional relevant MeSH terms:
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Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders Oxytocin Oxytocics |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013