Effects of Oxytocin Nasal Spray on Social Affiliation
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.
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
|Official Title:||Effects of Oxytocin Nasal Spray on Social Affiliation|
- Social Affiliation measured by Social Affiliative Role Play [ Time Frame: 2 hours ] [ Designated as safety issue: No ]In a vedeotaped 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 ] [ Designated as safety issue: No ]Oculomotor Delayed Response task and Continuous Performance task will be administered to examine the effects on working memory and attention.
|Study Start Date:||October 2009|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
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
The current study will examine the effects of intranasal oxytocin on physiological/cognitive markers of negative symptoms in 24 participants with schizophrenia spectrum traits. Subjects will be tested in two one-day studies carried out at least a month apart. Subjects will receive a 24 IU dose of intranasal oxytocin (or placebo) followed by a battery of cognitive/neurophysiological tests administered 50 minutes later completed over the next 155 minutes. A second dose of the drug (oxytocin or placebo) will be administered 2 hours after the 1st in order to maintain therapeutic plasma levels and to complete all testing.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00663039
|Contact: Matt Glassmanfirstname.lastname@example.org|
|Contact: Dawn Detamoreemail@example.com|
|United States, Maryland|
|Maryland Psychiatric Research Center||Recruiting|
|Catonsville, Maryland, United States, 21228|
|Contact: L I Hong, M.D. 410-402-6828 firstname.lastname@example.org|
|Contact: Dawn Detamore 410-402-6820 email@example.com|
|Sub-Investigator: Robert Buchanan, M.D.|
|Sub-Investigator: Ikwunga Wonodi, M.D.|
|Sub-Investigator: L. E. Hong, M.D.|
|Sub-Investigator: William T Carpenter, MD|
|Sub-Investigator: James Gold, PhD|
|Principal Investigator:||Henry Holcomb, M.D.||University of Maryland, Baltimore County|