Trial · Interventional

CompletedPhase 2Results postedRegistry data

Oxytocin and Social Cognition in Schizophrenia

NCTNCT00884897Other idHP-00041024Other idP50MH082999

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 2
Enrollment: 28 participants (actual)
Sponsor: University of Maryland, Baltimore · Other
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: Jan 2010
Primary completion: Jan 2012
Completion: Jan 2012
First posted: 21 Apr 2009 (estimated)
Last update posted: 2 Oct 2019
Conditions: Social Cognition · Social Anxiety · Emotional Intelligence

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2010201120122013

Ph 2
Oxytocin and Social Cognition in Schizophrenia
NCT00884897
Jan 2010 to Jan 2012

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Objective: Social Cognition and Emotional Intelligence have been shown to be deficient in patients with schizophrenia and these are not remediated by antipsychotic medications or psychosocial interventions. Social cognition is associated with functional outcome, an important step in striving for recovery in this population. The hormone and neurotransmitter, oxytocin, which has been associated with social bonding and trust has been shown to improve measures of some aspects of social cognition in humans. The study will assess the effect of acute administration of intranasal oxytocin on measures of social cognition and functioning as well as on emotional intelligence and symptoms. Study population: The study population will include patients with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who have been on a stable medication regimen for 6 weeks. We will enroll a total of 30 subjects (N=15 placebo and N=15 oxytocin groups). Experimental design and methods: After a one week lead in phase, participants will undergo 3 weeks of oxytocin (20 IU BID) or placebo administration (double blind) in addition to their existing medication regimen. Outcome measures will be administered during the lead in phase, and at the end of the study drug administration phase (under the acute effect of OT). The primary outcome measure will be the Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) and the Maryland Assessment of Social Competence (MASC). Secondary measures include rating from the domains of social cognition (emotion perception, attributional style, theory of mind and social perception), symptom rating and measures of social anxiety and quality of life. Side effects and symptoms will be measured weekly.

Interventions

OxytocinDrug
PlaceboDrug

Arms2

Experimental
Oxytocin
We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.
Placebo comparator
Placebo
We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.

Primary outcomes1

Outcomes the sponsor listed as primary.

To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients
Time frame · participants are assessed at baseline and end point
Registry description
Mayer-Salovay Caruso Emotional Intelligence Test (Mayer et al., 2002; MSCEIT) This is a self report instrument that consists of 141 items and 8 ability subscales, which assess four components (branches) of emotion processing: identifying emotions, using emotions, understanding emotions, and managing emotions. For this study we will focus on the managing emotions and understanding emotions components. There are 29 total items assessed with a total score ranging from 5-145. The higher the score the better the outcome.

Secondary outcomes(1)

To Determine Whether OT Improves Measures of Social Anxiety.
Time frame · Outcomes are compared between Baseline and endpoint
Registry description
To determine whether OT improves measures of social anxiety as measured by the Social Interaction Anxiety Scale. This assessment has 20 items scored 0-4 for a total minimum score of 0 and maximum score of 80. The lower the score the better the outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· participants are assessed at baseline and end point

To Determine Whether Exogenous OT Enhances Emotional Intelligence and Improves Performance on Measures of Social Cognition for Schizophrenia or Schizoaffective Patients

Group	Value (units on a scale)	Spread
Oxytocin	82.2	12.4
Placebo	77.9	9.8

Secondary and other outcome results(1)

Secondary outcomeMean· Outcomes are compared between Baseline and endpoint

To Determine Whether OT Improves Measures of Social Anxiety.

Group	Value (units on a scale)	Spread
Oxytocin	30.1	14.4
Placebo	33.9	17.8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
OxytocinWe will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis. Oxytocin: Oxytocin given as 20 IU BID	–	0 / 13	9 / 13
PlaceboWe will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT. Placebo: Placebo given as 20 IU BID	–	0 / 15	10 / 15

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2016

2 results

Relationship of plasma oxytocin levels to baseline symptoms and symptom changes during three weeks of daily oxytocin administration in people with schizophrenia.

Lee et al. 2016Schizophrenia researchcited by 17

PMID 26879587PMC4821731DOI 10.1016/j.schres.2016.02.014PUB-26879587

Rights unknown2 results

Source link See results (2)

Indexing hint: Randomized controlled trial · 2013

7 results

Effects of adjunctive intranasal oxytocin on olfactory identification and clinical symptoms in schizophrenia: results from a randomized double blind placebo controlled pilot study.

Lee et al. 2013Schizophrenia researchcited by 63

PMID 23415472PMC4125132DOI 10.1016/j.schres.2013.01.001PUB-23415472

Rights unknown7 results

Source link See results (7)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion criteria: All participants must: 1. Be between age 18 and 55. 2. Meet DSM-IV criteria for Schizophrenia or Schizoaffective Disorder. 3. Treated with a stabilized antipsychotic regimen (i.e., have had no change in antipsychotic medication in the previous six weeks and no change in dose for the past 30 days). Exclusion criteria: Participants will be excluded if they have evidence of: 1. DSM-IV criteria for substance dependence in the last 6 months or DSM-IV criteria for abuse in the past 30 days. 2. Cognitive impairment severe enough to preclude informed consent or valid responses on questionnaires. This is defined an as a score of less than 10 on the Evaluation to Sign Consent (ESC) and judged by the treating clinician. 3. Medical illness that in the view of the investigators would compromise participation in research. 4. History of polydipsia and/or hyponatremia 5. Clinically significant endocrine disorders, as judged by the PI. Abnormalities in prolactin levels and thyroid function tests associated with the use of dopamine antagonist medications will not be exclusionary. 6. Pregnancy, planning to become pregnant, or breastfeeding. In addition, women of childbearing age are required to use an effective form of birth control for the duration of the study. Effective forms of birth control include: * hormonal contraceptives (birth control pills, injectable hormones, vaginal ring hormones), * surgical sterility (tubal ligation or hysterectomy) * IUD * Diaphragm with spermicide * Condom with spermicide * Abstinence 7. Use of any drugs (prostaglandins, vasoconstricting agents or anesthetic medications, for example) that may interact with oxytocin. Justification: Avoidance of adverse interaction with oxytocin. Assessment tool(s): Clinical interview and toxicology screen 8. History of hypersensitivity to oxytocin or vehicle, i.e. propyl parahydroxybenzoate, methyl parahydroxybenzoate, chlorobutanol hemihydrate. Assessment tool: clinical interview 9. Presence of or history of clinically significant allergic rhinitis as assessed by the PI, M.D., or Nurse. Justification: Inflammation of nasal mucosa could interfere with mucosal absorption of intranasally administered OT. Current rhinitis from an upper respiratory infection should be resolved prior to enrollment in study.

PepBank is a research reference. Talk to a doctor before you use any peptide.