A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia
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|ClinicalTrials.gov Identifier: NCT03900754|
Recruitment Status : Recruiting
First Posted : April 3, 2019
Last Update Posted : March 16, 2021
|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|
|Actual Study Start Date :||January 13, 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.
- 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.
- 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).
- Hinting Task [ 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 Hinting Task, a well-validated tool where participants make social inferences after hearing 10 fictional conversations. Each conversation ends with one character's utterance and the participant is asked to determine its meaning.
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: Kimberly Sakai, BA||(415) 221-4810 ext email@example.com|
|United States, California|
|San Francisco VA Medical Center, San Francisco, CA||Recruiting|
|San Francisco, California, United States, 94121|
|Contact: Kimberly Sakai, BA 415-221-4810 ext 24704 firstname.lastname@example.org|
|Principal Investigator: Josh Woolley, BS|
|VA Greater Los Angeles Healthcare System, West Los Angeles, CA||Not yet recruiting|
|West Los Angeles, California, United States, 90073|
|Contact: Stephen Marder, MD email@example.com|
|Contact: Michael Green firstname.lastname@example.org|
|Principal Investigator:||Josh Woolley, BS||San Francisco VA Medical Center, San Francisco, CA|