Effects of Oxytocin Nasal Spray on Social Affiliation

NCT ID: NCT00663039

Last Updated: 2019-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2015-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Oxytocin, then Placebo

Participants first received 24IU of Oxytocin administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received placebo.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)

Placebo, then Oxytocin

Participants first received a placebo (saline nasal spray) administered intranasally with 6 total sprays (three in each nostril) on the morning and at midday of one study visit. Then, after at least month the participants returned for a second study day and received Oxytocin.

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Single dose (plus a booster dose) drug probe study using intranasal placebo

Interventions

Oxytocin

24 IU oxytocin (or Placebo) in a total of 6 puffs (3 puffs per nostril)

Intervention Type: DRUG

Placebo

Single dose (plus a booster dose) drug probe study using intranasal placebo

Intervention Type: DRUG

Other Intervention Names

Pitocin; Syntocinon

Eligibility Criteria

Inclusion Criteria

• Male/Female subjects between ages of 18-64 years
• The presence of 3 or more SSP symptoms (at least 2 of the SSP symptoms will be negative symptoms as defined by the schizoid traits)
• The presence of visuo-spatial working memory impairment as defined by error in the oculomotor delayed response (ODR) task of more than 0.5 SD above the mean values in healthy control subjects
• Relative of an individual with schizophrenia, schizo-affective, or schizophreniform disorder
• Able to provide written informed consent. Females are excluded due to risk of discomfort and unblinding due to potential uterine cramps induced by oxytocin.

Exclusion Criteria

• Subjects meeting criteria for a life-time diagnosis of any one of the DSM IV, Axis I psychotic disorders (exceptions being a single past episode of major depressive disorder with psychotic features or psychotic symptoms associated with substance abuse with the substance abuse ending 6-months prior to study participation) (this is for the SSP recruitment)
• Subjects meeting DSM-IV criteria for current alcohol or substance dependence (other than nicotine) within the last 6 months or DSM-IV criteria for alcohol or substance abuse (other than nicotine) within the last month
• Medical conditions that preclude participation in drug trials or assessments of outcome measures (including significant brain, cardiac, liver, lung, endocrinological or metabolic disorders)
• Received any investigational drug in the preceding four weeks.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Maryland, Baltimore

OTHER

Sponsor Role: lead

Responsible Party

MPRC

L. Elliot Hong, M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

L E Hong, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland, Baltimore

Locations

Maryland Psychiatric Research Center

Catonsville, Maryland, United States

Countries

United States

Other Identifiers

P50MH082999

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HP-00043595

Identifier Type: -

Identifier Source: org_study_id