Oxytocin and CBSST for People With Schizophrenia

Completed · Not applicable · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT01752712

Run by

University of Maryland, Baltimore

People needed

83

Starts

2014-01-01

Expected to finish

2016-08-01

Last updated by the study team

2019-09-25

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder
• 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.
• Male or female of any race.

You may not qualify if…

• 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

Where it is running

• University of California, San Diego — San Diego, California, United States
• Maryland Psychiatric Research Center — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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