A Phase III study to investigate the effect of EMD-RX5 on symptoms of psychological distress in adults with chronic pai

Phase 3

Suspended

• Conditions: Psychological Distress; Mental Health - Other mental health disorders

• Registration Number: ACTRN12622001319763
• Lead Sponsor: Emyria Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-12
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Chronic pain (defined as pain that has persisted for at least 3 months prior to date of consent)
- Self-reported at least mild psychological distress symptoms as measured by a baseline DASS-21 anxiety symptom score 8 or more
- If taking pain medications at the time of screening dose must be stable for at least one month prior to study screening
- Women of childbearing potential and men with sexual partners of childbearing potential must confirm the use of at least one acceptable form of contraception to be used throughout study participation.

Exclusion Criteria

- Current diagnosis of mental health disorder as defined by DSM-5
- Currently taking or has taken any psychotropic medications for treatment of mental health illness for one month prior to screening
- Current suicidality or self-harm ideation
- Pregnant females
- History of drug or alcohol abuse within 6 months of screening as per investigator judgement or a positive urine drug screen for THC
- Currently taking or has taken any cannabinoid products within 30 days of trial treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified