Prolonged Grief DisorderNCT04505904

Oxytocin and Approach-avoid in Grief

A study testing Syntocinon in people with Prolonged Grief Disorder and Bereavement, run by University of Arizona at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a completed project which was initiated prior to January 18,2017 Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability… Read more about this study

Who is it for?: Ages 55 to 80 years
Conditions the study is for: Prolonged Grief Disorder, Bereavement
What is being tested?: Syntocinon
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: 20 Mar 2015to 12 May 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment

Who cannot join

Inability to comprehend English;
medical contraindications for other components of the study,
active suicidality
active homicidality
active psychotic symptoms
ongoing major health conditions such as cancer; uncontrolled hypertension; and medications likely to impact the oxytocin system (e.g., systemic corticosteroids).
pregnant status or suspected pregnant status
premenopausal status

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Arizona
Tucson, Arizona, 85721

Other trials in United States

About this study

Official title: A Pull to be Close: the Differentiating Effects of Oxytocin and Grief Stimulus Type on Approach Behavior in Complicated Grief

This is a completed project which was initiated prior to January 18,2017

Background: Theoretical models of complicated grief (CG) suggest that maladaptive approach (e.g., perseverative proximity-seeking of the deceased) or avoidance (e.g., excessive avoidance of reminders) behaviors interfere with a person's ability to integrate the loss and recover from their loved one's death. Due in part to conflicting evidence, little mechanistic understanding of how these behaviors develop in grief exists. We sought to (1) identify behavioral differences between CG and non-CG groups based on implicit bias for grief-, deceased-, and social-related stimuli, and (2) test the role of the neuropeptide oxytocin in shaping approach/avoidance bias.

Methods: Widowed older adults with and without CG completed an approach/avoidance task measuring implicit bias for personalized, non-specific, grief-related, and other stimuli. In a double-blinded, randomized, counterbalanced design, each participant attended both an intranasal oxytocin session and a placebo session. Aims were to (1) identify differential effects of CG and stimulus type on implicit approach/avoidance bias [placebo session], and (2) investigate interactive effects of CG, stimulus type, and oxytocin vs. placebo on approach/avoidance bias [both sessions].

Conditions: Prolonged Grief Disorder, Bereavement
Being tested: Syntocinon, Placebo
Keywords: Oxytocin, Approach/Avoid, Older adults, Complicated Grief
Medical subject headings: Prolonged Grief Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SyntocinonDrug
Synthetic oxytocin spray, 24 IU per spray.
PlaceboDrug
Placebo spray with no active ingredient.

Study groups in NCT04505904
Study group	Role	What they receive
Syntocinon First	Experimental	Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received syntocinon at visit one and placebo at visit two. Syntocinon is 24 IU dose administered intranasally in spray form. Receives: Drug: Syntocinon; Drug: Placebo
Placebo First	Placebo comparator	Crossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received placebo at visit one, and syntocinon at visit two. Receives: Drug: Syntocinon; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.
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.
Measured: 120 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 201512 May 2017

First posted10 Aug 2020
Study start20 Mar 2015
Primary completion12 May 2017
Study completion12 May 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Prolonged Grief DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04505904
Sponsor's protocol ID: CGOT1620
Status last verified: Feb 2025
First submitted: 4 Aug 2020
Last updated: 4 Mar 2025
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Prolonged Grief Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pull to be Close: the Differentiating Effects of Oxytocin and Grief Stimulus Type on Approach Behavior in Complicated Grief
ClinicalTrials.gov ID: NCT04505904
Acronym / sponsor ID: CGOT1620
Conditions: Prolonged Grief Disorder, Bereavement
Keywords: Oxytocin, Approach/Avoid, Older adults, Complicated Grief
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: University of ArizonaUniversity, hospital or other
Study start: 20 Mar 2015 (actual)
Primary completion: 12 May 2017 (actual)
Study completion: 12 May 2017 (actual)
First posted: 10 Aug 2020 (actual)
Results: Posted 4 Mar 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a completed project which was initiated prior to January 18,2017

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Number of arms: 2

Arm	Type	Receives
Syntocinon First	Experimental	Drug: Syntocinon, Drug: PlaceboCrossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received syntocinon at visit one and placebo at visit two. Syntocinon is 24 IU dose administered intranasally in spray form.
Placebo First	Placebo comparator	Drug: Syntocinon, Drug: PlaceboCrossover design, all participants received experimental condition at either visit one or visit two, and the placebo at the other visit. This arm designates those who received placebo at visit one, and syntocinon at visit two.

Who may qualify

Ages: 55 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Adult individual experiencing death of a spouse or partner between 6 and 36 months prior to enrollment

Key exclusion criteria (8 listed)

Inability to comprehend English;
medical contraindications for other components of the study,
active suicidality
active homicidality
active psychotic symptoms

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SyntocinonSynthetic oxytocin spray, 24 IU per spray.	Drug	Placebo First, Syntocinon First
PlaceboPlacebo spray with no active ingredient.	Drug	Placebo First, Syntocinon First

Primary outcome

Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.
Time frame: 120 minutes
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.

Results and safety

Results posted to the registry on 4 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
With Complicated Grief: Syntocinon First, Then Placebo	11	9
With Complicated Grief: Placebo First, Then Syntocinon	11	8
Without Complicated Grief: Syntocinon First, Then Placebo	11	11
Without Complicated Grief: Placebo First, Then Syntocinon	11	11

Primary outcome: Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task.

Time frame: 120 minutes. Mean (Standard Deviation). Unit: Milliseconds (contrast score)

Measure	With Complicated Grief n = 17	Noncomplicated Grief Group n = 22
Syntocinon First	29 (21)	18 (18.9)
Placebo First	7.5 (21)	13.0 (11.5)

Population analysed: 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.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Syntocinon	0 of 39 (0%)	2 of 39 (5.1%)	0 of 39
Placebo	0 of 39 (0%)	1 of 39 (2.6%)	0 of 39

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Mechanisms Underlying Late-Life Prolonged Grief Disorder
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Syntocinon in people with Prolonged Grief Disorder and Bereavement, run by University of Arizona at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reaction Time (ms) of a Push or Pull of a Joystick in a Standard Interactive Approach/Avoid Task. (time frame: 120 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04505904.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2025.