NCT03566069

Intranasal Oxytocin as Enhancer of Psychotherapy Outcomes in Severe Mental Illness: A Randomized Controlled Study

Active, enrolled Phase 2 Last updated 27 June 2024

What this trial tests

Phase 2 trial testing Intranasal Oxytocin in Severe Mental Illness in 120 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2018

Primary endpoint
1 June 2025

1 June 2025

Quick facts

Lead sponsor	Shalvata Mental Health Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	1 June 2018
Primary completion	1 June 2025
Estimated completion	1 June 2025
Sites	1 location across Israel

Drugs / interventions tested

• Intranasal Oxytocin — full drug profile →
• Intranasal Placebo — full drug profile →

Conditions studied

• Severe Mental Illness — all drugs for Severe Mental Illness →

Sponsor

Shalvata Mental Health Center — full company profile →

Who can join

18 and older, any sex, with Severe Mental Illness. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in Depression and Anxiety Symptoms
  Time frame: assessing change over 10 time points, at baseline, twice a week after psychotherapy sessions over a month of intervention and at Follow-Up a month post intervention for each participant
  As measured repeatedly by the Hopkins symptoms checklist -short form (HSCL-11) (Lutz, Tholen, Schurch, \& Berking, 2006)

Sponsor's own description

Intranasal administration of Oxytocin (OT) has been found to improve social communication skills and encoding of social cues. Studies indicate that the provision of OT enhances the ability to develop trust 1, to improve the benefits of social support during social stress induction tasks 2 and to increase positive communication during couples' conflict discussions 3. These studies, and many others, point to the potential beneficial effects of OT as a facilitator of relationship-focused processes such as psychotherapy. Studies assessing the effect of OT as a possible outcome enhancer in psychotherapy for clinical populations are scarce, and their findings are largely inconsistent 4. Reasons for this state of affairs include the complexity of recruitment in this population; the provision of single-dose OT, which tends to cause a lower and insufficient effect 5; and methodological constraints, such as the lack of a control group 6 or insufficient probing of interpersonal factors 7.

In this study we intend to overcome these constraints by evaluating the impact of intranasal administration of OT in patients suffering from acute stages of anxiety and depression disorders and undergoing intensive, relationship-focused psychotherapy during psychiatric hospitalization. One-hundred-and-twenty admitted patients with anxiety and depression disorders will be randomized and double-blindly allocated to two groups: (a) psychotherapy + OT (n=60), and (b) psychotherapy + placebo (n=60). Patients will be followed for three weeks, beginning at the start of their hospitalization, and will be assessed for the severity of their anxiety and depression symptoms; their working alliance with their therapist; and their treatment outcome after each session. Psychotherapy will be delivered twice a week. Intranasal OT will be administered twice a day.

This study can provide insights regarding the potential involvement of OT in the trajectories leading to the production of detectable changes in brain activity following psychotherapy. Additionally, it can support the development of an integrating model combining recent findings in psychotherapy research pertaining to the significant role of therapeutic alliance in psychotherapy outcome, and findings from neuroimaging studies. Finally, provision of OT as a psychotherapy enhancer can facilitate a rapid therapeutic response and subsequently replace aggressive psychiatric medication usage, needed to create a rapid decrease of distress during psychiatric admissions.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Pharmacotherapy of Anxiety Disorders: Current and Emerging Treatment Options.
   Garakani A, Murrough JW, Freire RC, Thom RP, et al · · 2020 · cited 213× · PMID 33424664 · DOI 10.3389/fpsyt.2020.595584
2. A double-edged hormone: The moderating role of personality and attachment on oxytocin's treatment facilitation effect.
   Tzur Bitan D, Grossman-Giron A, Sedoff O, Zilcha-Mano S, et al · · 2023 · cited 2× · PMID 36905736 · DOI 10.1016/j.psyneuen.2023.106074
3. Case Report: Oxytocin and Its Association With Psychotherapy Process and Outcome.
   Grossman-Giron A, Tzur Bitan D, Zilcha-Mano S, Nitzan U, et al · · 2021 · cited 2× · PMID 34594245 · DOI 10.3389/fpsyt.2021.691055
4. Inpatient's, therapist's and staff's expectations regarding treatment and their effects on placebo response in the psychiatric ward - results from an add-on oxytocin RCT.
   Nitzan U, Grossman-Girron A, Sedoff O, Maoz H, et al · · 2024 · cited 1× · PMID 39052100 · DOI 10.1007/s00213-024-06593-x
5. Intranasal Nano-Delivery Systems: Emerging Strategies for Central Nervous System Disease Therapeutics.
   Gao T, Chu Q, Xing X, Liu Y, et al · · 2026 · PMID 41873359 · DOI 10.2147/ijn.s588836