A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03900754|
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : December 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Oxytocin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||188 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||The study uses a combined within- and between-subject placebo-controlled study design. After screening, participants will be randomized into two study arms for the fMRI phase of the study. In each study arm, participants will complete a placebo-controlled, within-subject, pharmaco fMRI paradigm with one of two possible dosages of oxytocin (20 or 40IU) and placebo. 75 participants will be randomized to receive 20IU oxytocin and placebo and 75 will be randomized to receive 40IU oxytocin and placebo, with the order of administration randomized and separated by two weeks. Following the fMRI phase of the study, participants will be randomized to receive the same dosage of oxytocin the participant received in the fMRI phase, or placebo, twice daily for 3 weeks.|
|Masking:||Double (Participant, Investigator)|
|Masking Description:||Double Blind|
|Official Title:||A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia|
|Estimated Study Start Date :||January 6, 2020|
|Estimated Primary Completion Date :||September 30, 2024|
|Estimated Study Completion Date :||September 30, 2024|
Experimental: Intranasal Oxytocin
Dosages of oxytocin: 20IU or 40IU.
Intranasal administration of oxytocin
Other Name: Syntocinon
Placebo Comparator: Placebo
- Social Functioning Score [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]The Social Functioning Scale is a 79-item semi-structured interview based assessment that includes [a global summary score (primary outcome) as well as seven subscales (secondary outcomes): social engagement, interpersonal communication, independence, competence, recreation, prosocial, and employment.] A mean of the subscale scores provides overall score of social functioning. Each subscale score is transformed into a standard distribution with a mean of 100 and standard deviation of 15 for comparability and interpretation. Higher scores indicates a high level of functioning.
- SSPA score (social skills performance assessment) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Social skills will be assessed using the Social Skills Performance Assessment (SSPA), which consists of three role-plays in which the participant is assigned a role and interacts with an assessor for three minutes. The SSPA has established convergent and divergent validity. In order to evaluate empathy in social situations, the investigators will also include a fourth role-play in which participants attempt to console an upset friend played by the assessor. Role-plays will be video-recorded and rated on interest, fluency, clarity, focus, affect, overall conversation/argument, grooming, social appropriateness, and possibly submissiveness/persistence on a scale from 1 very poor to 5 very good. In addition, the investigators will code participant's verbal content and prosody, and facial expressivity using standardized coding systems. The total scores range 8-40 or 9-45 dependent on role-play (higher scores indicate appropriate social skills).
- TASIT III Scores (the awareness of social inference test) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Theory of Mind (ToM) will be assessed using The Awareness of Social Interference Test (TASIT) III, a well-validated audiovisual tool participants make social inferences after viewing 16 video vignettes of actors engaging in social scenarios. In half of the videos, one character depicts a white lie and the other half of the videos consists of a speaker using complex sarcasm. The ability to interpret the vignettes correctly was assessed via a set of 4 yes/no questions for each vignette that focused on the speaker's belief, intention, what the speaker intended the listener to comprehend, and the speaker's emotional state. TASIT III performance has been linked to social functioning in SZ, and the investigators have previously captured OT effects in SZ using this tool. In TASIT III, validated alternate forms of will be counterbalanced across testing days. Higher scores indicate normative social perception.
- CAINS Score (clinical assessment interview for negative symptoms) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Negative symptoms will be assessed with the CAINS, comprising two subscales reflecting the negative symptom factors: The 9-item Motivation and Pleasure subscale (each item is scored from 0 no impairments to 4 severe deficit) captures experiential negative symptoms by assessing motivation, behavior, and pleasure derived from social, vocational, and recreational activities over the past week. The MAP total score therefore ranges from 0-36. The 4-item Expression subscale (each item is scored from 0 no impairment to 4 severe deficit) captures both non-verbal (face, posture) and verbal expressivity (output, prosody). The EXP total score ranges from 0 to 16 (higher scores indicate greater severity of symptoms). The CAINS has excellent convergent and divergent validity.
- CAMS (Computerized Assessment of Mental Status) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Participants will watch 5 short (~90s) videos previously shown to induce strong emotional responses (joy, sadness, fear, disgust, pain) in healthy people. Facial expressivity including valence (positive, negative) and intensity, during video viewing will be coded by trained and calibrated raters using the validated Facial Expression Coding System.
- Brief-IPSAQ (internal, personal, and situational attributions questionnaire) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Attributional bias will be assessed with the brief-IPSAQ (Internal, Personal, and Situational Attributions Questionnaire, which presents hypothetical events (8 positive, 8 negative) involving a friend. For each event, participants determine the most likely cause of the situation and decide if the cause is linked to the participant, the participant's friend, or the situation. Two cognitive bias scores are derived: externalizing (EB) (i.e., the number of internal attributions for positive events minus internal attributions for negative events) and personalizing (PB) (i.e., the number of personal external attributions for negative events divided by the number of personal plus situational external attributions for negative events).] Positive EB indicates strong self-serving biases, PB score > 0.5 indicates tendency to use personal rather than situational external attributions for negative events.
- QLS Scale (quality of life) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Quality of Life will be assessed with the Quality of Life Scale (QLS), a 9-item assessment that measures domains such as interpersonal relations, occupation role functioning, and intrapsychic foundations. Each item is rated from 0 to 6 with the lower values indicating greater severity of symptoms. As such, the total score ranges from 0-54 (higher scores indicate good quality of life).
- SAPS Scale (Scale for Assessment of Positive Symptoms) [ Time Frame: From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration ]Positive symptoms will be assessed with the Scale for Assessment of Positive Symptoms (SAPS), a 34-item interview-based assessment that focuses on four sub-scales, which are hallucinations, delusions, disorganized behavior, and thought disorder. There are thirty individual symptom ratings (from 0 none to 5 severe) and four global symptom severity scores.
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): NCT03900754
|Contact: Josh Woolley, BS||(415) 221-4810 ext 4117||Josh.Woolley@ucsf.edu|
|Contact: Lisa Lin, BA||(415) 221-4810 ext firstname.lastname@example.org|
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA||Not yet recruiting|
|San Francisco, California, United States, 94121|
|Contact: Lisa Lin, BA 415-221-4810 ext 23318 email@example.com|
|Principal Investigator: Josh Woolley, BS|
|Principal Investigator:||Josh Woolley, BS||San Francisco VA Medical Center, San Francisco, CA|