Administrating Oxytocin to Treat Treatment Schizophrenia and Schizo-affective Patients

NCT01598623 | Unknown Phase 2

• 1 other identifier: SHEBA-12-9103-MW-CTIL
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are:

1. 1.To evaluate the effect of OT compared to placebo, as add-on to anti-psychotics, on social functioning in schizophrenia.
2. 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. 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. 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. 5.To assess in the relationships between levels of salivary OT and vasopressin, and social interactions in schizophrenia.
6. 6.To assess in the relationships between levels of salivary OT and vasopressin, and response to OT treatment.

Conditions

Oxytocin + Non Specific Counselling; Oxytocin + Social Skills Training; Placebo + Non Specific Counselling; Placebo + Social Skills Training

Outcome Measures

Primary Outcomes (1)

• Total score of structured assessment of social interaction

  Change from baseline in the total score of structured assessment of social interaction in Oxytocin compared with placebo on all patients.

  Baseline and week 3

Secondary Outcomes (6)

• Total score of structured assessment of social interaction

  Total score of structured assessment of social interaction at week 3

• PANSS positive, negative and general psychopathology scales scores

  PANSS positive, negative and general psychopathology scales scores at week 1

• Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status

  Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status at week 3

• Levels of salivary OT,genetic,epigenetic status and total score of structured assessment of social interaction and PANSS scores.

  Levels of salivary OT,genetic and epigenetic status at week 3

• PANSS positive, negative and general psychopathology scales scores

  PANSS positive, negative and general psychopathology scales scores at week 2

Study Arms (4)

Oxytocin+ Non Specific Counselling

EXPERIMENTAL

Drug: Oxytocin

Oxytocin + Social Skills training

EXPERIMENTAL

Drug: Oxytocin; Behavioral: Social Skills Training

Placebo + Non Specific Counselling

PLACEBO COMPARATOR

Behavioral: Placebo + Non Specific Counselling

Placebo + Social Skills Training

EXPERIMENTAL

Behavioral: Social Skills Training

Interventions

Oxytocin DRUG

24 IU Intranasal, three times daily (morning, noon and evening, before meals) for 3 weeks (21 days).

Oxytocin + Social Skills training; Oxytocin+ Non Specific Counselling

Social Skills Training BEHAVIORAL

three times a week for three weeks.

Oxytocin + Social Skills training; Placebo + Social Skills Training

Placebo + Non Specific Counselling BEHAVIORAL

Placebo + Non Specific Counselling

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, 18-65 years of age, inclusive
• Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device \[IUD\]).
• Willing and able to provide informed consent, after the nature of the study has been fully explained
• Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID.
• Symptoms: PANSS total score ≤75
• 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
• Receiving the same antipsychotic medication for 2 weeks before randomization.
• Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission, provided no medication change since hospitalization.
• 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.

You may not qualify if:

• Unwilling or unable, in the opinion of the Investigator, to comply with study instructions.
• Pregnant or breast-feeding.
• Clinically significant medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning).
• At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others.
• 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.
• Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
• 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.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Sheba medical center

Ramat Gan, 52621, Israel

Location

Related Publications (1)

• Saporta-Wiesel L, Feldman R, Levi L, Davidson M, Burshtein S, Gur R, Zagoory-Sharon O, Amiaz R, Park J, Davis JM, Weiser M. Intranasal Oxytocin Combined With Social Skills Training for Schizophrenia: An Add-on Randomized Controlled Trial. Schizophr Bull Open. 2024 Oct 21;5(1):sgae022. doi: 10.1093/schizbullopen/sgae022. eCollection 2024 Jan.

  PMID: 39502135 DERIVED

MeSH Terms

Interventions

Oxytocin

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

• Mark Weiser, MD

  Sheba Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mark B Weiser, MD

CONTACT

+972526666575; mweiser@netvision.net.il

Liron Saporta

CONTACT

+972542228032; liron.saporta@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 15, 2012
• Study Start: May 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: September 1, 2014
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

IL (1)