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Administrating Oxytocin to Treat Treatment Schizophrenia and Schizo-affective Patients (OXY-S-01)

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ClinicalTrials.gov Identifier: NCT01598623
Recruitment Status : Unknown
Verified November 2013 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 15, 2012
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Sheba Medical Center

Brief Summary:

The objectives of the study are:

  1. To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on social functioning in schizophrenia.
  2. To evaluate the effect of socially oriented CBT administered to patients immediately after they receive OT, compared to patients who receive OT with not-socially oriented CBT, and compared to patients who receive socially oriented CBT without OT. The investigators hypothesize that OT and socially oriented CBT will have a synergistic effect, and will be better than OT or CBT alone.
  3. Use a detailed, in depth analysis of social interaction to assess these putative effects of OT. The investigators hypothesize that the use of this analysis will show larger treatment effects of OT than previously shown in less sensitive assessments, such as PANSS.
  4. To assess the effect of epigenetic status on response to OT. The investigators hypothesize that epigenetic variants associated with lower OT plasma levels will be associated with greater response to OT treatment.
  5. To assess in the relationships between levels of salivary OT and vasopressin, and social interactions in schizophrenia.
  6. To assess in the relationships between levels of salivary OT and vasopressin, and response to OT treatment.

Condition or disease Intervention/treatment Phase
Oxytocin + Non Specific Counselling Oxytocin + Social Skills Training Placebo + Non Specific Counselling Placebo + Social Skills Training Drug: Oxytocin Behavioral: Social Skills Training Behavioral: Placebo + Non Specific Counselling Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Trial Administering Oxytocin vs Placebo as add-on to Antipsychotics in Patients With Schizophrenia and Schizo-affective Disorder
Study Start Date : May 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin+ Non Specific Counselling Drug: Oxytocin
24 IU Intranasal, three times daily (morning, noon and evening, before meals) for 3 weeks (21 days).

Experimental: Oxytocin + Social Skills training Drug: Oxytocin
24 IU Intranasal, three times daily (morning, noon and evening, before meals) for 3 weeks (21 days).

Behavioral: Social Skills Training
three times a week for three weeks.

Placebo Comparator: Placebo + Non Specific Counselling Behavioral: Placebo + Non Specific Counselling
Experimental: Placebo + Social Skills Training Behavioral: Social Skills Training
three times a week for three weeks.




Primary Outcome Measures :
  1. Total score of structured assessment of social interaction [ Time Frame: Baseline and week 3 ]
    Change from baseline in the total score of structured assessment of social interaction in Oxytocin compared with placebo on all patients.


Secondary Outcome Measures :
  1. Total score of structured assessment of social interaction [ Time Frame: Total score of structured assessment of social interaction at week 3 ]
    Change from baseline in the in Oxytocin with and without social skills training compared with placebo with and without social skills training.

  2. PANSS positive, negative and general psychopathology scales scores [ Time Frame: PANSS positive, negative and general psychopathology scales scores at week 1 ]
    Change from baseline in Oxytocin compared with placebo on PANSS positive, negative and general psychopathology scales scores at 1 week

  3. Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status [ Time Frame: Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status at week 3 ]
    Correlation between response to OT treatment(change from baseline in total score of structured assessment of social interaction and PANSS scores), genetic(types of variants of the OXT and OXTR genes)and epigenetic status(methylation on these genes) at 3 weeks

  4. Levels of salivary OT,genetic,epigenetic status and total score of structured assessment of social interaction and PANSS scores. [ Time Frame: Levels of salivary OT,genetic and epigenetic status at week 3 ]
    Correlations between levels of salivary OT,genetic(type of variants of the OXT and OXTR genes),epigenetic(methylation on these genes)and response to OT treatment(change in total score of structured assessment of social interaction and PANSS scores) at 3 weeks

  5. PANSS positive, negative and general psychopathology scales scores [ Time Frame: PANSS positive, negative and general psychopathology scales scores at week 2 ]
    Change from baseline in Oxytocin compared with placebo on PANSS positive, negative and general psychopathology scales scores at 2 weeks

  6. PANSS positive, negative and general psychopathology scales scores [ Time Frame: PANSS positive, negative and general psychopathology scales scores at week 3 ]
    Change from baseline in Oxytocin compared with placebo on PANSS positive, negative and general psychopathology scales scores at 3 weeks



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, 18-65 years of age, inclusive
  2. Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]).
  3. Willing and able to provide informed consent, after the nature of the study has been fully explained
  4. Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID.
  5. Symptoms: PANSS total score ≤75
  6. A score of 4 (moderate) or higher on at least one, or more of the following PANSS negative items: emotional withdrawal, poor rapport, passive-apathetic social withdrawal
  7. Receiving the same antipsychotic medication for 2 weeks before randomization.
  8. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission, provided no medication change since hospitalization.
  9. Adjunctive treatment with anticholinergic agents, beta-blockers, mood stabilizers, antidepressants; and anxiolytics will be allowed provided that patients have been on the medication for at least 2 weeks prior to entry into the screening phase of the study.

Exclusion Criteria:

  1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
  2. Pregnant or breast-feeding.
  3. Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
  4. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
  5. Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included.
  6. Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
  7. Patients with significantly impaired renal or liver function, defined as GOP and or GPT levels >3 times above highest normal value, and or blood creatinine levels above 1.5 will be excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01598623


Contacts
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Contact: Mark B Weiser, MD +972526666575 mweiser@netvision.net.il
Contact: Liron Saporta +972542228032 liron.saporta@gmail.com

Locations
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Israel
Sheba medical center
Ramat Gan, Israel, 52621
Contact: Mark B Weiser, MD    +972526666575    mweiser@netvision.net.il   
Contact: Liron Saporta    +972542228032    liron.saporta@gmail.com   
Sub-Investigator: Shimon Burshtein, MD         
Sponsors and Collaborators
Sheba Medical Center
Investigators
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Principal Investigator: Mark Weiser, MD Sheba Medical Center
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Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01598623    
Other Study ID Numbers: SHEBA-12-9103-MW-CTIL
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs