Oxytocin and CBSST for People With Schizophrenia

NCT01752712 | Completed Results DMC

• 1 other identifier: HP-00054628
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Oxytocin; Social function; CBSST

Outcome Measures

Primary Outcomes (1)

• Birchwood Social Function Scale (BSFS) Total Score

  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.

  Treatment weeks 0, 12, and 24, plus follow-up week 36

Secondary Outcomes (5)

• Defeatist Performance Attitudes Scale (DPAS) Total Score

  Treatment weeks 0, 12, and 24, plus follow-up week 36

• Asocial Belief Scale (ABS) Total Score

  Treatment weeks 0, 12, and 24, plus follow-up week 36

• Schedule for Assessment of Negative Symptoms (SANS) Total Score

  Every 4 weeks during the treatment phase, plus follow-up week 36

• Brief Psychiatric Rating Scale (BPRS) Total Score

  Every 4 weeks during the treatment phase, plus follow-up week 36

• Brief Psychiatric Rating Scale (BPRS) Psychosis Score

  Every 4 weeks during the treatment phase, plus follow-up week 36

Study Arms (2)

CBSST + oxytocin

EXPERIMENTAL

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

CBSST + placebo

PLACEBO COMPARATOR

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

Interventions

CBSST + Oxytocin DRUG

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.

CBSST + oxytocin

CBSST + Placebo DRUG

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.

Also known as: sugar pill

CBSST + placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• University of California, San Diego: collaborator

Study Sites (2)

University of California, San Diego

San Diego, California, 92093, United States

Location

Maryland Psychiatric Research Center

Baltimore, Maryland, 21228, United States

Location

Related Publications (1)

• Buchanan RW, Kelly DL, Strauss GP, Gold JM, Weiner E, Zaranski J, Chen S, Blatt F, Holden J, Granholm E. Combined Oxytocin and Cognitive Behavioral Social Skills Training for Social Function in People With Schizophrenia. J Clin Psychopharmacol. 2021 May-Jun 01;41(3):236-243. doi: 10.1097/JCP.0000000000001397.

  PMID: 33783399 DERIVED

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Social Adjustment

Interventions

Oxytocin; Sugars

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Carbohydrates

Results Point of Contact

• Title: Robert W. Buchanan, M.D.
• Organization: Maryland Psychiatric Research Center

rwbuchanan@mprc.umaryland.edu

410-402-7876

Study Officials

• Robert Buchanan, MD

  University of Maryland, College Park

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Maryland Psychiatric Research Center, Outpatient Research Program

Study Record Dates

• First Submitted: December 14, 2012
• First Posted: December 19, 2012
• Study Start: January 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: September 25, 2019
• Results First Posted: October 31, 2017

Record last verified: 2017-11

Locations

US (2)