Phase 4 Depression and Anxiety Trial, Not Yet Recruiting NCT06303076 Sponsor: Sultan Qaboos University Condition: Depression and Anxiety
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Phase 4 Depression and Anxiety Trial, Not Yet Recruiting

NCT06303076
Not Yet Recruiting Phase 4

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • Adults of any gender between 18 and 60 years old.
  • People who have been diagnosed with primary insomnia by a psychiatry specialist, using standard DSM-5 diagnostic guidelines.
  • People who are able to give written consent to participate.
  • People who are willing to follow the study procedures and attend follow-up appointments.
  • People who complete a medical check-up at Al-Masarah Hospital before being enrolled, which includes a review of medical history, a physical examination (including a heart tracing/ECG), a check of vital signs (such as blood pressure and pulse), a blood sugar test, and a set of blood tests covering blood count, liver function, kidney function, thyroid function, and cholesterol levels.
  • People who receive medical clearance from the hospital doctor following that check-up.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose insomnia is caused by another underlying condition (known as secondary insomnia).
  • People with a history of substance abuse.
  • People who have been diagnosed with a significant or unstable medical condition, a significant or unstable psychiatric disorder, or an intellectual disability.
  • People who are pregnant or breastfeeding, or people of childbearing potential who are not using an adequate form of contraception (natural birth spacing methods are not considered adequate for this trial).
  • People who have a known allergy or sensitivity to Tizanidine or Benzodiazepines.
  • People who are unable to understand or communicate with the research team.
  • People who have taken part in another clinical trial involving an investigational drug within the 30 days before joining this study.
  • People who have taken any over-the-counter or prescription sleep medication within the 30 days before joining this study.
  • People who have used any substance known to affect the brain or nervous system in a way that influences sleep within the 30 days before joining this study.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 20 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Phone: +96892281145

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Phase 4
Sponsor
Sultan Qaboos University
Registry
ClinicalTrials.gov
Start date
1 September 2024
Est. completion
1 September 2026

Primary endpoints

Pittsburgh Sleep Quality Index

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 20 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov