Effects of Oxytocin Nasal Spray on Social Affiliation

NCT00663039 | Completed Phase 2 Results DMC

• 2 other identifiers: HP-00043595P50MH082999
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Eye movements; phenotype; biochemical; relatives

Outcome Measures

Primary Outcomes (1)

• Social Affiliation Measured by Social Affiliative Role Play

  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. Participants are rated on a 5 point Likert scale ranging from very poor (1) to Very Good (5).

  30 minutes

Secondary Outcomes (8)

• Hopkins Verbal Learning Test (HVLT)

  15 minutes

• Trust Game

  20 minutes

• RVIP Reaction Times

  25 minutes

• Rapid Visual Information Processing Test (RVIP)

  25 minutes

• Brief Assessments of Cognition for Schizophrenia

  5 minutes

Study Arms (2)

Oxytocin, then Placebo

EXPERIMENTAL

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.

Drug: Oxytocin

Placebo, then Oxytocin

EXPERIMENTAL

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.

Drug: Placebo

Interventions

Oxytocin DRUG

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

Also known as: Pitocin, Syntocinon

Oxytocin, then Placebo

Placebo DRUG

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

Placebo, then Oxytocin

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Maryland Psychiatric Research Center

Catonsville, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Elliot Hong
• Organization: MPRC

ehong@mprc.umaryland.edu

410-402-6828

Study Officials

• L E Hong, M.D.

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: L. Elliot Hong, M.D.

Study Record Dates

• First Submitted: April 17, 2008
• First Posted: April 21, 2008
• Study Start: October 1, 2009
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: September 9, 2019
• Results First Posted: December 13, 2018

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)