Trial Outcomes & Findings for Oxytocin and Approach-avoid in Grief (NCT NCT04505904)

Last Updated: 2025-03-04

Results Overview

Participants completed the approach avoid task twice per session, with reversed instructions on the second run (i.e., "pull for yellow" became "push for yellow"). Each seven-minute run of the task consisted of 144 2500ms trials (288 trials per visit, 576 trials total across runs/sessions; 500ms inter-trial-interval). Order of instructions (i.e., "push yellow" vs. "pull yellow") was randomized and counterbalanced across participants and sessions, to address potential for order effects/habituation. Stimuli were presented via Inquisit 4 (2014), in a pseudorandomized order determined by genetic algorithm (Wager \& Nichols, 2003). Relative approach/avoidance bias was computed by subtracting median response time (RT; latency to joystick full extension) on PULL/approach trials in each stimulus category from PUSH/avoid trials in the same category (Rinck \& Becker, 2007). Positive response bias values indicate relative approach bias; negative values indicate relative avoidance bias.

Recruitment status

COMPLETED

Study phase

Target enrollment

44 participants

Primary outcome timeframe

120 minutes

Results posted on

2025-03-04

Participant Flow

Participant milestones

Participant milestones
Measure	With Complicated Grief: Syntocinon First, Then Placebo Crossover design. This arm designates the Complicated grief group, as designated to \>=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.	With Complicated Grief: Placebo First, Then Syntocinon Crossover design. This arm designates the Complicated grief group, as designated to \>=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and syntocinon at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.	Without Complicated Grief: Syntocinon First, Then Placebo Crossover design. This arm designates the Non-Complicated grief group, as designated to \<25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.	Without Complicated Grief: Placebo First, Then Syntocinon Crossover design. This arm designates the Non-Complicated grief group, as designated to \<25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and experimental condition at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.
Overall Study STARTED	11	11	11	11
Overall Study COMPLETED	9	8	11	11
Overall Study NOT COMPLETED	2	3	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	With Complicated Grief: Syntocinon First, Then Placebo Crossover design. This arm designates the Complicated grief group, as designated to \>=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received experimental condition at visit one, and placebo at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.	With Complicated Grief: Placebo First, Then Syntocinon Crossover design. This arm designates the Complicated grief group, as designated to \>=25 cutoff score on standardized measure (the Inventory of Complicated Grief) who received placebo condition at visit one, and syntocinon at visit two 7-10 days later. Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.
Overall Study Withdrawal by Subject	1	2
Overall Study Physician Decision	1	0
Overall Study Adverse Event	0	1

Baseline Characteristics

Oxytocin and Approach-avoid in Grief

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Complicated Grief n=17 Participants Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates the Complicated grief group, as designated to \>25 cutoff score on standardized measure (the Inventory of Complicated Grief). All participants in this group received both synthetic oxytocin and placebo Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.	Noncomplicated Grief n=22 Participants Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates the noncomplicated grief group, as divided based on cutoff score on standardized measure (the Inventory of Complicated Grief) Syntocinon: Synthetic oxytocin spray, 24 IU per spray. Placebo: Placebo spray with no active ingredient.	Total n=39 Participants Total of all reporting groups
Age, Continuous	68.96 years STANDARD_DEVIATION 6.68 • n=5 Participants	69.83 years STANDARD_DEVIATION 6.68 • n=7 Participants	69.45 years STANDARD_DEVIATION 6.68 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	3 Participants n=7 Participants	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	22 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	22 Participants n=7 Participants	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants	22 participants n=7 Participants	39 participants n=5 Participants
Inventory of Complicated Grief	35.18 units on a scale STANDARD_DEVIATION 7.9 • n=5 Participants	14.47 units on a scale STANDARD_DEVIATION 6.36 • n=7 Participants	23.5 units on a scale STANDARD_DEVIATION 7.0 • n=5 Participants
Beck Depression Inventory - II	16.41 units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants	6 units on a scale STANDARD_DEVIATION 4.86 • n=7 Participants	10.4 units on a scale STANDARD_DEVIATION 5.7 • n=5 Participants

PRIMARY outcome

Timeframe: 120 minutes

Population: Of note, for analysis purposes, we collapsed across crossover groups to yield two groups, complicated grief and non-complicated grief. This is consistent with reporting methods of other relevant literature in this area and allows for direct conceptual comparison to these previous studies.

Outcome measures

Outcome measures
Measure	With Complicated Grief n=17 Participants Those with \> =25 score on ICG	Noncomplicated Grief Group n=22 Participants Those scoring \< 25 score on Inventory of Complicated Grief (ICG).
Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. Syntocinon First	29 Milliseconds (contrast score) Standard Deviation 21	18 Milliseconds (contrast score) Standard Deviation 18.9
Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. Placebo First	7.5 Milliseconds (contrast score) Standard Deviation 21	13.0 Milliseconds (contrast score) Standard Deviation 11.5

Adverse Events

Syntocinon

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Syntocinon n=39 participants at risk Participants with adverse event during syntocinon condition	Placebo n=39 participants at risk Participants with adverse events during placebo condition
Gastrointestinal disorders Nausea	2.6% 1/39 • Number of events 1 • 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection. All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.	0.00% 0/39 • 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection. All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.
General disorders Back pain	0.00% 0/39 • 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection. All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.	2.6% 1/39 • Number of events 1 • 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection. All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.
General disorders Incidental Finding	2.6% 1/39 • Number of events 1 • 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection. All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.	0.00% 0/39 • 6 hours per participant (two visits of three hours each). Participants were monitored for any adverse even to nasal spray during laboratory visit for data collection. All adverse events encountered in this study are classified as "other" as they are not serious or all-cause mortality.

Additional Information

Brian Arizmendi

University of Arizona

Phone: 9168473623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place