Schizophrenia Clinical Trial
Official title:
Oxytocin as Adjunctive Treatment of Schizophrenia
Verified date | August 2019 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The focus of the current project is to advance our understanding of the effects of oxytocin
(OT) on components of social cognition in schizophrenia (SCZ). Despite the rapid increase in
our understanding of the role of OT in rodent models of social behavior and an explosion of
interest in the prosocial effects of OT in healthy controls, little work has been done to
dissect the potential effects of OT on SCZ subjects with social deficits. Social deficits are
a crucial aspect of the functional impairments that limit the rehabilitation of patients with
SCZ. In particular, SCZ patients with enduring negative symptoms (deficit syndrome,
Kirkpatrick et al. 1989) have prominent social deficits as a core feature of this subtype of
the illness. Our currently available medications do very little to improve these social
deficits. Hence it is of utmost public health importance to address the knowledge gap
regarding the potential of OT to improve social function in this illness. Intact social
function depends on the competent functioning of several cognitive domains that subserve
perception of social cues and the generation of motivated social behavior. We propose to
conduct a pharmacological challenge study of OT vs. placebo administration to study the
effects of OT on specific components of social cognition in male deficit syndrome SCZ
subjects.
Primary Hypothesis: Intranasal OT will improve social cognition in subjects with deficit
syndrome SCZ.
Status | Completed |
Enrollment | 39 |
Est. completion date | March 15, 2017 |
Est. primary completion date | March 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 65 Years |
Eligibility |
Subjects for the study will be forty male VA patients with a diagnosis of schizophrenia.
Diagnosis will be determined using the Structured Clinical Interview for DSM-IV Axis I
Disorders/SCID-P (Spitzer et al. 1992). Subjects must be categorized as having a primary
deficit syndrome on the Kirkpatrick Schedule for the Deficit Syndrome (Kirkpatrick et al.
1989). Additional inclusion criteria: 1. Subjects must be between 18 and 65 years old at the time of study screening. 2. Subjects must demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in this research study. 3. Subjects must have been psychiatrically and medically stable for 8 weeks prior to consent in the judgment of the Principal Investigator. 4. Subjects must have been maintained on a stable treatment of antipsychotics and/or other concomitant psychotropic treatment for at least 6 weeks prior to consent. 5. Subjects must have no more than a moderate severity rating on hallucinations and unusual thought content as shown by a score of = 4 on the Positive and Negative Symptoms Scale (PANSS). 6. Subjects must be able to validly complete the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB), in the judgment of the consenting study staff person. 7. Subjects must have the visual, auditory, and motor capacity to use the computer software in the judgment of the consenting study staff person. Visual acuity must be at least 20/30 corrected. 8. Subjects must have a minimal level of extrapyramidal symptoms as shown by a Simpson-Angus Scale total score of no more than 6. 9. Subjects must have a minimal level of depressive symptoms as shown by a Calgary Depression Scale (CDSS) total score of no more than 10. Exclusion criteria: 1. Female sex 2. History of bipolar disorder 3. Active substance dependence within the prior 30 days (cigarette smoking is allowed) 4. Has had a psychiatric hospitalization in the 8 weeks prior to consent. 5. Suicidal or homicidal ideation in the previous six months 6. Subjects who have answered 'yes' to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on the Columbia-Suicide Severity Rating Scale, C-SSRS, or who have answered 'yes' to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act or behavior) on the C-SSRS "Suicidal Behavior" portion shall be excluded from the study if ideation or behavior occurred within one month of consent. Subjects excluded for this reason will be referred for appropriate treatment. 7. History of mental retardation or pervasive developmental disorder 8. History of neurological disorder (e.g., traumatic brain injury, seizure disorder, Parkinson's Disease, dementia), loss of consciousness for more than 10 minutes due to head trauma, known HIV infection, or AIDS 9. Treatment with a benzodiazepine in the two weeks prior to consent. Control Participants: Inclusion Criteria: - Male - Ages 18-65 Exclusion Criteria: - Female - History of a psychotic disorder, or depression requiring medication - Active substance abuse or dependence within the prior 30 days - Medical admission within the past six months Criteria to rule out subjects with medical problems likely to present a confound: - Known HIV infection or AIDS - History of TBI - Seizure disorder - Known Alzheimer's Disease or other dementia - Minimal cognitive impairment (MCI) - Parkinson's Disease - Unstable medical condition |
Country | Name | City | State |
---|---|---|---|
United States | Atlanta VA Medical Center | Decatur | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University | Atlanta VA Medical Center |
United States,
Andari E, Duhamel JR, Zalla T, Herbrecht E, Leboyer M, Sirigu A. Promoting social behavior with oxytocin in high-functioning autism spectrum disorders. Proc Natl Acad Sci U S A. 2010 Mar 2;107(9):4389-94. doi: 10.1073/pnas.0910249107. Epub 2010 Feb 16. — View Citation
Guastella AJ, Mitchell PB, Dadds MR. Oxytocin increases gaze to the eye region of human faces. Biol Psychiatry. 2008 Jan 1;63(1):3-5. Epub 2007 Sep 21. — View Citation
Mueser KT, Doonan R, Penn DL, Blanchard JJ, Bellack AS, Nishith P, DeLeon J. Emotion recognition and social competence in chronic schizophrenia. J Abnorm Psychol. 1996 May;105(2):271-5. — View Citation
Young LJ, Murphy Young AZ, Hammock EA. Anatomy and neurochemistry of the pair bond. J Comp Neurol. 2005 Dec 5;493(1):51-7. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eye Tracking: Fixation Count | In order to assess the processing of social stimuli, subjects will be presented with a series of human faces of mixed sex and race showing neutral emotions and instructed to visually scan each face. Six regions of interest (ROIs) will be defined for each face stimulus: eyes, nose mouth, forehead, cheeks, and outside the contours of the face. The data will be processed off line for each face stimulus as the total time of fixation inside each of the ROIs. Refers to the number of fixations that occurred on the face of the stimulus presented to the participant during the eye-tracking assessment. | Day 1 | |
Primary | Eye Tracking: Dwell Duration Time | Refers to the amount of time that an individual spent looking at the face of the stimulus presented to the participant during the eye-tracking assessment. | Day 1 | |
Primary | Social Reward Ball-tossing Task | Subjects will perform a computerized Social Reward Ball-Tossing Task in which they decide to return the ball to one of three fictional partners. The photos of the partners and their reciprocity in returning the ball to the subject will be manipulated. The number of balls sent to each of the partners will be quantified to assess socially reinforced learning. The result is expressed in number of ball tosses sent to the subject by a fictional player with a positive expression MINUS the number of ball tosses sent to the subject by a fictional player with a negative expression. These measures will be compared between the control subjects, oxytocin and placebo group. | Day 1 | |
Primary | Non-Social Reward Ball-tossing Game | Social reward trials will be interleaved with non-social trials where subjects will play with random geometric shapes or landscape scenes associated with positive and negative non-social rewards. The outcome measure reported herein is the number of ball tosses the subject sends to shape A minus the number of ball tosses sent to shape B. | Day 1 | |
Primary | Facial Emotion Identification Task | The stimuli are 19 standard black and white pictures of faces showing one of six different emotions (happy, sad, angry, surprise, disgusted, ashamed) that were developed by Ekman and Friesen (1976). The pictures are shown for 15 sec, with 10 sec between each face. After the presentation of each face the subject is asked to choose which of the six emotions was displayed. The score on the test is the sum of correct responses. Subjects in the two groups (oxytocin vs. placebo) will be compared. | Day 1 |
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