- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01752712
Oxytocin and CBSST for People With Schizophrenia
Combined Oxytocin and CBSST for Social Function in People With Schizophrenia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
A NIMH mission priority is the development of new and better interventions, whose focus extends beyond symptom amelioration to the development of interventions that allow people who suffer from severe mental illnesses "to live full and productive lives" (NIMH Strategic Plan, 2008). In particular, the NIMH Strategic Plan notes the importance of translating "research on the biological causes of disorder to inform and develop psychosocial and biomedical interventions that target core features of disease, assess outcomes appropriate to the course of illness under study, and develop study designs that have impact on these features." The current proposal is built upon the observations that: 1) people with schizophrenia are characterized by marked impairments in their social function; 2) current pharmacological treatments do not address these impairments; 3) CBSST has been shown to have modest effects on social function in people with schizophrenia. This limited efficacy may be related to the lack of interest or drive people with schizophrenia have for social interactions; 4) oxytocin plays a critical role in normal social affiliative behavior through a) the reduction of anxiety or social risk aversion, b) the enhancement of motivation for prosocial approach or affiliative behavior, and/or c) increased modulation of the salience and processing of social cues; and 5) decreased oxytocin is associated with social function impairments in people with schizophrenia.
The proposed study is based on the proposition that the use of a pharmacological agent, whose behavioral effects compliment the psychological mechanisms of action of a psychosocial intervention, is an important adaptation of an intervention previously shown to have moderate effects on social function. The addition of oxytocin to CBSST is hypothesized to: 1) enhance the reduction of defeatist performance beliefs by reducing social risk aversiveness and avoidance, which would increase exposure to reinforcement and corrective feedback; 2) enhance social skill acquisition through improvement of proximal social behaviors, e.g. making eye contact and attending to the facial expressions of social partners; and 3) facilitate the translation of learned social skills into community practice through its effects on prosocial attachment behaviors, reduction in social disinterest, and effects on distal behaviors, e.g. initiating conversations and responding to social invitations. Increased social risk taking within and between sessions would expose participants to a greater frequency of positive feedback and success experiences, which would provide evidence to dispute their defeatist beliefs and social disinterest attitudes. In addition, increased social risk taking could improve homework adherence (e.g., practicing talking to people in the community) and engagement in new community activities. These interactive effects would subsequently lead to a substantial improvement in CBSST efficacy for social function. Ultimately, the importance of improved social function is the effect that such improvement would have on overall levels of health and functioning, including vocational outcome.
The proposed study will enable us to collect preliminary data on the acceptability, efficacy, feasibility, and safety of the proposed intervention. In particular, this would be the first study to examine the safety of long-term oxytocin in this population. The study will also provide critical data on the feasibility of recruiting and retaining participants with schizophrenia in a long-term intervention, which combines two different therapeutic modalities: CBSST and oxytocin. If found to be efficacious, feasible, and well-tolerated, we will plan to conduct a larger study, which would include the use of cognitive and imaging biomarkers, to more fully elucidate the mechanism of action of the observed treatment effects. The investigators will address the following specific aims:
Aim #1 (Efficacy): To determine if CBSST + oxytocin compared to CBSST + placebo-oxytocin is associated with improved social function.
Aim #2 (Safety): To determine if CBSST + oxytocin compared to CBSST + placebo-oxytocin is associated with increased incidence of side effects.
Aim #3 (Change Mechanism): To determine if CBSST + oxytocin compared to CBSST + placebo-oxytocin 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 memory measures.
Aim #4 (Other Outcomes): To determine if CBSST + oxytocin compared to CBSST + placebo-oxytocin is associated with improved neuropsychological test performance, and/or decreased positive, negative, and/or anxiety/depression symptoms, and clinical global improvement.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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San Diego, California, United States, 92093
- University of California, San Diego
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Maryland
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Baltimore, Maryland, United States, 21228
- Maryland Psychiatric Research Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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).
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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.
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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).
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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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Birchwood Social Function Scale (BSFS) Total Score
Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36
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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.
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Treatment weeks 0, 12, and 24, plus follow-up week 36
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Defeatist Performance Attitudes Scale (DPAS) Total Score
Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36
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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.
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Treatment weeks 0, 12, and 24, plus follow-up week 36
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Asocial Belief Scale (ABS) Total Score
Time Frame: Treatment weeks 0, 12, and 24, plus follow-up week 36
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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.
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Treatment weeks 0, 12, and 24, plus follow-up week 36
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Schedule for Assessment of Negative Symptoms (SANS) Total Score
Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36
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SANS total score range = 0-85.
Higher scores indicate more severe negative symptoms.
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Every 4 weeks during the treatment phase, plus follow-up week 36
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Brief Psychiatric Rating Scale (BPRS) Total Score
Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36
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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.
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Every 4 weeks during the treatment phase, plus follow-up week 36
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Brief Psychiatric Rating Scale (BPRS) Psychosis Score
Time Frame: Every 4 weeks during the treatment phase, plus follow-up week 36
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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.
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Every 4 weeks during the treatment phase, plus follow-up week 36
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Robert Buchanan, MD, University of Maryland, College Park
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HP-00054628
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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