Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
University of Maryland |
---|---|
Information provided by: | University of Maryland |
ClinicalTrials.gov Identifier: | NCT00663039 |
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 | Intervention | Phase |
---|---|---|
Schizophrenia |
Drug: Oxytocin Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Crossover Assignment |
Official Title: | Effects of Oxytocin Nasal Spray on Social Affiliation |
Estimated Enrollment: | 24 |
Study Start Date: | January 2009 |
Estimated Study Completion Date: | July 2013 |
Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Active Comparator
Oxytocin
|
Drug: Oxytocin
24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)
|
2: Placebo Comparator |
Drug: Placebo
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.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Gunvant K Thaker, M.D. | 410-402-6821 | gthaker@mprc.umaryland.edu |
United States, Maryland | |
Maryland Psychiatric Research Center | |
Catonsville, Maryland, United States, 21228 |
Principal Investigator: | Gunvant K Thaker, M.D. | University of Maryland |
Responsible Party: | University of Maryland, Baltimore ( Gunvant Thaker, MD ) |
Study ID Numbers: | H29597 |
Study First Received: | April 17, 2008 |
Last Updated: | October 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00663039 History of Changes |
Health Authority: | United States: Institutional Review Board |
Schizophrenia Eye movements phenotype biochemical relatives |
Schizophrenia Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features Oxytocin |
Schizophrenia Oxytocics Mental Disorders Therapeutic Uses Physiological Effects of Drugs |
Reproductive Control Agents Pharmacologic Actions Schizophrenia and Disorders with Psychotic Features Oxytocin |