Oxytocin and CBSST for People With Schizophrenia
|ClinicalTrials.gov Identifier: NCT01752712|
Recruitment Status : Completed
First Posted : December 19, 2012
Results First Posted : October 31, 2017
Last Update Posted : February 7, 2018
|First Submitted Date ICMJE||December 14, 2012|
|First Posted Date ICMJE||December 19, 2012|
|Results First Submitted Date||October 2, 2017|
|Results First Posted Date||October 31, 2017|
|Last Update Posted Date||February 7, 2018|
|Study Start Date ICMJE||January 2014|
|Actual Primary Completion Date||August 2016 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||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.
|Original Primary Outcome Measures ICMJE
||Determine if CBSST + oxytocin compared to CBSST + placebo is associated with improved social function. [ Time Frame: 3 years ]
|Change History||Complete list of historical versions of study NCT01752712 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE
||Determine if CBSST + oxytocin compared to CBSST + placebo is associated with increased incidence of side effects. [ Time Frame: 3 years ]|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE
||Determine if CBSST + oxytocin compared to CBSST + placebo 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 [ Time Frame: 3 years ]
|Brief Title ICMJE||Oxytocin and CBSST for People With Schizophrenia|
|Official Title ICMJE||Combined Oxytocin and CBSST for Social Function in People With Schizophrenia|
|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.|
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 ICMJE||Interventional|
|Study Phase||Not Applicable|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Actual Enrollment ICMJE
|Original Estimated Enrollment ICMJE
|Actual Study Completion Date||August 2016|
|Actual Primary Completion Date||August 2016 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 55 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01752712|
|Other Study ID Numbers ICMJE||HP-00054628|
|Has Data Monitoring Committee||Yes|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Robert W. Buchanan, University of Maryland|
|Study Sponsor ICMJE||University of Maryland|
|Collaborators ICMJE||University of California, San Diego|
|PRS Account||University of Maryland|
|Verification Date||November 2017|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP