Oxytocin and CBSST for People With Schizophrenia

• Sponsor: University of Maryland
• Collaborator: University of California, San Diego
• Information provided by (Responsible Party): Robert W. Buchanan, University of Maryland

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia; Schizoaffective Disorder	Drug: CBSST + Oxytocin; Drug: CBSST + Placebo	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	83 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
Official Title:	Combined Oxytocin and CBSST for Social Function in People With Schizophrenia
Study Start Date :	January 2014
Actual Primary Completion Date :	August 2016
Actual Study Completion Date :	August 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Birchwood Social Function Scale (BSFS) Total Score [ Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36 ]
   Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. There are 7 individual sections, with each section asking about different aspects of social functioning. Scores for Section 1: "Social Engagement Withdrawal" range from 0-15; Section 2: "Interpersonal Communication/Relationships" ranges from 0-30; Section 3: "Prosocial Activities" range is 0-66; Section 4: "Recreation" ranges from 0-48; Section 5: "Independence (Performance)" ranges from 0-39; Section 6: "Independence (Competence)" ranges from 0-39; and Section 7: "Occupation/Employment" ranges from 0-6 if the participant is unemployed or 7-10 if the participant is employed. The minimum value possible is 0 for participants who are unemployed and 7 for those with employment. The total BSFS score is calculated by adding the total scores from each of the 7 sections, with a maximum total score of 247. A lower total score indicates a lower social function rating.

Secondary Outcome Measures :

1. Defeatist Performance Attitudes Scale (DPAS) Total Score [ Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36 ]
   Determine if CBSST + oxytocin compared to CBSST + placebo is associated with defeatist performance beliefs. The total DPAS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Agree Totally" to "7=Disagree Totally". Total scores range from a minimum score of 18 to a maximum score of 126. Reverse scoring was applied to make higher scores indicate a stronger defeatist attitude.
2. Asocial Belief Scale (ABS) Total Score [ Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36 ]
   Determine if CBSST + oxytocin compared to CBSST + placebo is associated with asocial beliefs. The total ABS score is calculated by adding the scores for items #1-#15. Each scale is provided a True/False response, with True responses equaling 1 point and False responses equaling 0 points. In calculating the ABS total score, four of the 15 items of the ABS were reverse scored. A lower total score indicates more severe asocial beliefs.
3. Schedule for Assessment of Negative Symptoms (SANS) Total Score [ Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36 ]
   SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
4. Brief Psychiatric Rating Scale (BPRS) Total Score [ Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36 ]
   The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating.
5. Brief Psychiatric Rating Scale (BPRS) Psychosis Score [ Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36 ]
   The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 55 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder
2. Scale for the Assessment of Negative Symptoms asociality item score ≥ 2
3. Considered clinically stable by the treating psychiatrist
4. 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.
5. Male or female of any race.

Exclusion Criteria:

1. Organic brain disorder, including cerebrovascular accident; epilepsy; traumatic brain injury, loss of consciousness (LOC) for more than 30 minutes
2. Mental retardation
3. 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
4. Participant is pregnant or is lactating
5. History of chronic allergic rhinitis
6. 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.
7. DSM-IV-TR diagnosis of alcohol or substance abuse (except nicotine) within the last month
8. 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
9. 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

Locations

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United States, California
University of California, San Diego
San Diego, California, United States, 92093
United States, Maryland
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228

Sponsors and Collaborators

University of Maryland

University of California, San Diego

Investigators

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Principal Investigator:	Robert Buchanan, MD	University of Maryland

More Information

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Responsible Party:	Robert W. Buchanan, Chief, Maryland Psychiatric Research Center, Outpatient Research Program, University of Maryland
ClinicalTrials.gov Identifier:	NCT01752712 History of Changes
Other Study ID Numbers:	HP-00054628
First Posted:	December 19, 2012
Results First Posted:	October 31, 2017
Last Update Posted:	February 7, 2018
Last Verified:	November 2017

Keywords provided by Robert W. Buchanan, University of Maryland:

Oxytocin; Social function; CBSST

Additional relevant MeSH terms:

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Schizophrenia; Psychotic Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders	Oxytocin; Oxytocics; Reproductive Control Agents; Physiological Effects of Drugs