NCT03765138 is a Phase 3 clinical trial of PE/Pramipexole in PTSD, sponsored by Research Foundation for Mental Hygiene, Inc..

Who is sponsoring NCT03765138?

NCT03765138 is sponsored by Research Foundation for Mental Hygiene, Inc..

What drugs are being tested in NCT03765138?

Interventions in NCT03765138: PE/Pramipexole.

Is NCT03765138 still recruiting?

NCT03765138 is currently terminated. Last updated 26 November 2019.

Are results published for NCT03765138?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-11-26 · How we verify

NCT03765138

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Combined Treatment of Prolonged Exposure and Pramipexole for Posttraumatic Stress Disorder and Depression

Terminated Phase 3 Results posted Last updated 26 November 2019

What this trial tests

Phase 3 trial testing PE/Pramipexole in PTSD in 1 participant. Terminated before completion.

Timeline

19 February 2019

Primary endpoint
26 August 2019

26 August 2019

Quick facts

Lead sponsor	Research Foundation for Mental Hygiene, Inc.
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	1
Start date	19 February 2019
Primary completion	26 August 2019
Estimated completion	26 August 2019
Sites	1 location across United States

Drugs / interventions tested

PE/Pramipexole

Conditions studied

PTSD — all drugs for PTSD →
MDD — all drugs for MDD →

Sponsor

Research Foundation for Mental Hygiene, Inc.

Who can join

Adults 18 to 60, any sex, with PTSD or MDD. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This pilot study aims to test the safety, feasibility, and initial efficacy of combined 10 week treatment of prolonged exposure (PE) and Pramipexole in patients with comorbid posttraumatic stress disorder (PTSD) and depression (MDD). Resting state functional connectivity (rsFC) will be assessed at baseline and en of treatment.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Sex, Pramipexole and Tiagabine Affect Behavioral and Hormonal Response to Traumatic Stress in a Mouse Model of PTSD.
Malikowska-Racia N, Salat K, Gdula-Argasinska J, Popik P. · · 2021 · cited 5× · PMID 34276379 · DOI 10.3389/fphar.2021.691598

Verify or expand the search:

Other recruiting trials for PTSD

Currently open trials in the same condition.

NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07010757 — Testing an Integrated PTSD and Weight Management Intervention: A Hybrid Type 1 Trial · NA · recruiting
NCT07372586 — Behavioral Health Collaborative Care Model in an ICU Recovery Clinic · NA · recruiting
NCT07390786 — Behavioral Health Collaborative Care Model in Post-ICU Clinic Family Pilot · NA · recruiting
NCT07469098 — Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events · Phase 2 · recruiting

Other Research Foundation for Mental Hygiene, Inc. trials

Trials by the same sponsor.

NCT06159075 — Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment: a Cross-Cultural Lens · NA · completed
NCT05826132 — Digital Mental Health Care for COVID-19 High-Risk Populations - Phase 2 · NA · completed
NCT05818228 — Reducing Self-Stigma Among Individuals with History of Childhood Maltreatment · NA · completed
NCT05645042 — Transcendental Meditation in Veterans and First Responders With PTSD · NA · terminated
NCT05057624 — Gaze-Contingent Music Reward Treatment for PTSD · NA · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03765138 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Research Foundation for Mental Hygiene, Inc.
Last refreshed: 26 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03765138.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing