Administrating Oxytocin to Treat Treatment Schizophrenia and Schizo-affective Patients

What Was Tested

This registered phase 2 trial tested Oxytocin.

The objectives of the study are: 1.

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.

It had four arms (groups): Oxytocin+ Non Specific Counselling (experimental), Oxytocin + Social Skills training (experimental), Placebo + Non Specific Counselling (placebo comparator) and Placebo + Social Skills Training (experimental).

The registry classes the interventions as behavioral and drug.

More on the Plan

Oxytocin (Granholm, McQuaid et al.) is a nine amino-acid neuropeptide synthesized in the hypothalamus, has found to modulate social behaviors in mammals, including humans (Insel and Young 2001; Kosfeld, Heinrichs et al. 2005).

Only two published studies have investigated the therapeutic potential of OT in schizophrenia; both administered OT in addition to anti-psychotic treatment.

There is ongoing research aiming to validate these findings.

Vasopressin is also a peptide with a putative effect on social interaction (Ebstein, Israel et al. 2009; Heinrichs, von Dawans et al. 2009).

Who Took Part

48 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: unwilling or unable, in the opinion of the investigator, to comply with study instructions; pregnant or breast-feeding.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Oxytocin group and the comparison group should start out alike.

The Oxytocin group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Oxytocin, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-05 with completion listed for 2014-02.

It ran at 1 site in Israel.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Total score of structured assessment of social interaction (time frame: Baseline and week 3).

It also tracked 6 secondary outcomes, for example Total score of structured assessment of social interaction, PANSS positive, negative and general psychopathology scales scores, Total score of structured assessment of social interaction and PANSS scores, genetic and epigenetic status, Levels of salivary OT,genetic,epigenetic status and total score of structured assessment of social interaction and PANSS scores, PANSS positive, negative and general psychopathology scales scores and PANSS positive, negative and general psychopathology scales scores.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Oxytocin in 48 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.