Clinical trial

A Pharmaco-imaging Approach to Predicting Social Functioning and Clinical Responses to Oxytocin Administration in Schizophrenia

Name
MHBB-011-18F
Description
Schizophrenia has a devastating and disproportionate effect on veterans compared to the general US population. Some of the most disabling symptoms, such as low motivation, difficulty expressing emotions, and decreased ability to infer the mental states of others, cause poor social functioning. This means that veterans with schizophrenia have trouble navigating interpersonal interactions and building meaningful relationships in the community. Unfortunately, current antipsychotic medications typically only improve positive symptoms but fail to improve social functioning deficits, which are strong predictors of poor quality of life and functional outcomes. Oxytocin, a peptide found in the brain, plays an important role in social behavior and is known to moderate affiliation, stress, and learning across taxa. In this study, the investigators will test whether oxytocin could be an effective treatment for social functioning deficits in schizophrenia. The investigators will examine changes in brain activation to understand how oxytocin affects behavior and to predict which individuals may benefit from oxytocin treatment.
Trial arms
Trial start
2020-01-13
Estimated PCD
2024-01-31
Trial end
2024-01-31
Status
Terminated
Phase
Early phase I
Treatment
Oxytocin
Intranasal administration of oxytocin
Arms:
Intranasal Oxytocin
Other names:
Syntocinon
Placebo
Placebo
Arms:
Placebo
Size
26
Primary endpoint
Social Functioning Score
From the baseline visit in the chronic OT administration portion of the study design to after three weeks of oxytocin administration
Eligibility criteria
Inclusion Criteria: * Veteran * age 18-70 * a diagnosis of schizophrenia, schizophreniform, schizoaffective, or brief psychotic disorder determined by the Structured Clinical Interview for DSM-5 * no medication changes or psychiatric hospitalizations in the past month * SFS modified raw score of no more than 75 Exclusion Criteria: * substance use disorder in the past month, except mild to moderate cannabis use disorder * illness affecting the nasal passages * significant neurological/medical disorder * pacemakers * extensive dental work * claustrophobia * deafness * inability to read * currently participating in a psychosocial intervention targeting social functioning deficits * currently taking high dose testosterone or estrogen/progesterone * inability to complete VOT
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '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.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Double Blind', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 26, 'type': 'ACTUAL'}}
Updated at
2024-04-24

1 organization

1 product

1 drug

1 indication

Product
Oxytocin
Indication
Schizophrenia