Oxytocin as Adjunctive Therapy for Schizophrenia

NCT01699997 | Completed Phase 2 DMC

• 1 other identifier: RF-2010-2311148
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 7

Brief Summary

Background: A large body of research has shown that Oxytocin (OXT) is an important prosocial peptide and there is also initial evidence that the central OXT system is altered in several mental disorders that are characterized by severe social disturbances and deficits, such as anxiety disorders with prominent social dysfunction (e.g., schizophrenia), mood disorders and borderline personality disorder. OXT may reduce psychotic symptoms and may diminish certain social cognition deficits that are not improved by current antipsychotic medications. Aims: The project has two main aims, listed below:

1. 1.To assess the efficacy of intranasal OXT in reducing negative symptoms in patients with schizophrenia in association with second-generation antipsychotics (SGA);
2. 2.To use an Emotional Priming Paradigm task to assess pre- and post-treatment change in the patients general cognitive and emotional status.

Conditions

Schizophrenia

Keywords

Schizophrenia; Oxytocin; RCT

Outcome Measures

Primary Outcomes (1)

• Change in PANSS negative score, as measured at T0 and at 2,4,6 and 8 months.

  Using the PANSS negative score as primary end-point, the investigators expect to observe a reduction in PANSS negative subscale scores in the treated group ranging from 0.9 to 2, with an effect size Cohens d=0.45, in agreement with the results of a previous study, in which authors who observed a reduction of 1.7 with an effect size Cohens d= 0.5. The investigators also expect that OXT will have a positive influence on the patients quality of life and reduction of PANSS positive subscale score. Correlations between OXT plasma levels, symptoms, and response to treatment will be evaluated to identify respondent and non-respondent patient groups

  8 months

Secondary Outcomes (1)

• PANSS total score change.

  8 months

Other Outcomes (2)

• Brief Assessment of Cognitive deficits in Schizophrenics (BACS) score change

  8 months

• Reading the Mind in the Eyes Test (RMET) score change.

  8 months

Study Arms (2)

Oxytocin

EXPERIMENTAL

Each treatment will consist of 10 insufflations (5/nostril alternating between nostrils) of OXT Spray, which contains approximately 40 international units (IU) of OXT

Drug: Oxytocin

Placebo vial

PLACEBO COMPARATOR

Each treatment will consist of 10 insufflations (5/nostril alternating between nostrils) of placebo Spray, which contains all OXT Spray ingredients except for oxytocin.

Drug: Placebo

Interventions

Oxytocin DRUG

Intranasal spray with 40 IU of OXT

Oxytocin

Placebo DRUG

Intranasal spray with placebo solution

Placebo vial

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a diagnosis of SZ, according to DSM-IV criteria, for at least one year, evaluated with SCID/P
• A minimum PANSS total score of 55 (indicating moderate severity, due to ongoing AP treatment) .
• A minimum CGI-S score of 4
• Age between 18 and 45 years
• A disorder duration of no longer than 10 years
• Women of childbearing age must test negative for pregnancy at the time of enrolment.
• All patients must:
• be on a therapeutic dose of a SGA (or a maximum 2 SGAs) with no major dose changes for at least 4 weeks.
• have the ability to provide informed consent
• be able to use a nasal spray
• reside in the service catchment area
• show evidence of no alcohol or substance dependence in the last year

You may not qualify if:

• Diagnosis of mental retardation
• Diagnosis of organic mental disorder
• History of no response to treatment with clozapine
• History of hypersensitivity to OXT or vehicle
• Alcohol or substance dependence in the last year
• Presence of, or history of clinically significant allergic rhinitis as assessed by the treating clinician
• Being pregnant or breastfeeding
• Having given birth in the past 6 months or breast-feeding in the past 3 months
• Low literacy as indicated by an inability to read and understand the consent form

Sponsors & Collaborators

• IRCCS Centro San Giovanni di Dio Fatebenefratelli: lead

Study Sites (7)

Statistical Unit, Institute of Biomathematics, University of Urbino

Urbino, Pesaro Urbino, Italy

Location

IRCCS Fatebenefratelli

Brescia, 25125, Italy

Location

Department of Mental Health

Desenzano, 25024, Italy

Location

Institute of Neuroscience, National Research Council

Milan, 20129, Italy

Location

Department of Mental Health

Padua, 35124, Italy

Location

Psychiatric Clinic, University of Pisa

Pisa, 56100, Italy

Location

Psychiatric Clinic, University of Udine

Udine, 33100, Italy

Location

Related Publications (2)

• Dagani J, Sisti D, Abelli M, Di Paolo L, Pini S, Raimondi S, Rocchi MB, Saviotti FM, Scocco P, Totaro S, Balestrieri M, de Girolamo G. Do we need oxytocin to treat schizophrenia? A randomized clinical trial. Schizophr Res. 2016 Apr;172(1-3):158-64. doi: 10.1016/j.schres.2016.02.011. Epub 2016 Feb 14.

  PMID: 26883950 DERIVED

• Lee MR, Wehring HJ, McMahon RP, Liu F, Linthicum J, Verbalis JG, Buchanan RW, Strauss GP, Rubin LH, Kelly DL. Relationship of plasma oxytocin levels to baseline symptoms and symptom changes during three weeks of daily oxytocin administration in people with schizophrenia. Schizophr Res. 2016 Apr;172(1-3):165-8. doi: 10.1016/j.schres.2016.02.014. Epub 2016 Feb 12.

  PMID: 26879587 DERIVED

Related Links

• This is the website of the Coordinating Centre

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

Study Officials

• Giovanni de Girolamo, M.D.

  IRCCS Fatebenefratelli, Brescia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Responsible of Psychiatric Epidemiology and Evaluation Unit

Study Record Dates

• First Submitted: October 2, 2012
• First Posted: October 4, 2012
• Study Start: January 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 24, 2016

Record last verified: 2016-02

Locations

IT (7)