Effects of Oxytocin Nasal Spray on Social Affiliation
|ClinicalTrials.gov Identifier: NCT00663039|
Recruitment Status : Active, not recruiting
First Posted : April 21, 2008
Last Update Posted : November 8, 2017
Schizophrenia is a complex and heritable disorder that encompasses several clinical symptom domains and functional impairments. Existing treatments of schizophrenia, although effective against positive symptoms, fail to benefit negative symptoms, the focus of the current protocol. One of the strategies of novel drug development depends on identifying heritable physiological deficits that mark the disease liability and are thought to occur along the causal pathway of negative symptoms. These heritable physiological deficits are often found in the biological relatives of schizophrenia proband; particularly those who have schizophrenia related personality styles [defined by schizophrenia spectrum personalities (SSP) in the diagnostic system], even though they do not have the full-blown illness. The current protocol will pilot a strategy of targeting biomarkers of negative symptoms using intranasal oxytocin in relatives of schizophrenia patients. The drug probe studies in such non-clinical sample have several advantages including the absence of other drug treatment that may modulate the response, and the lack of generalized deficits causing problems with task comprehension/engagement that may mute the therapeutic signal. In addition, finding of efficacy of the experimental drug on the target physiological deficit and the associated symptoms has clinical implications on its own rights. This is because about 25% of subjects with schizophrenia spectrum personality disorders experience serious functional impairments.
Oxytocin is an extensively used drug, which is well tolerated with few serious side effects. Several lines of evidence suggest its putative role in the treatment of negatives symptoms, particularly a lack of social drive and related symptoms.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Oxytocin Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Effects of Oxytocin Nasal Spray on Social Affiliation|
|Actual Study Start Date :||October 2009|
|Actual Primary Completion Date :||July 2015|
|Estimated Study Completion Date :||January 2018|
Active Comparator: 1
24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)
|Placebo Comparator: 2||
Single dose (plus a booster dose) drug probe study using intranasal placebo
- Social Affiliation measured by Social Affiliative Role Play [ Time Frame: 2 hours ]In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale.
- Cognitive (memory and attention) [ Time Frame: 2 hours ]Oculomotor Delayed Response task and Continuous Performance task will be administered to examine the effects on working memory and attention.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00663039
|United States, Maryland|
|Maryland Psychiatric Research Center|
|Catonsville, Maryland, United States, 21228|
|Principal Investigator:||L E Hong, M.D.||University of Maryland|