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Oxytocin and CBSST for People With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01752712
Recruitment Status : Completed
First Posted : December 19, 2012
Results First Posted : October 31, 2017
Last Update Posted : December 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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
Schizophrenia Schizoaffective Disorder Drug: CBSST + Oxytocin Drug: CBSST + Placebo

  Show Detailed Description

Study Design

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
Primary Completion Date : August 2016
Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin
U.S. FDA Resources

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 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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752712


Locations
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
Principal Investigator: Robert Buchanan, MD University of Maryland
More Information

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    Key Record Dates
Results First Posted: October 31, 2017
Last Update Posted: December 6, 2017
Last Verified: November 2017

Keywords provided by Robert W. Buchanan, University of Maryland:
Oxytocin
Social function
CBSST

Additional relevant MeSH terms:
Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs