Efficacy of Melatonin, Low-dose Quetiapine, or Placebo in Patients With Psychiatric Disorders and Comorbid Insomnia
Recruiting
Phase 2
Phase 3
Interventional Study
Psychiatric Disorders
Insomnia
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 16 – 64
- Sex
- Any
- Trial phase
- Phase 2/3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 255 (estimated)
- Sponsor
- Lone Baandrup · Other
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
The goal of this investigator-initiated, randomized, blinded, 3-armed placebo-controlled, pragmatic, clinical superiority trial is to examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomnia in patients with psychiatric disorders. The aims of the study are:
* To examine the efficacy of melatonin or low-dose quetiapine versus placebo for treatment of insomn…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
* 16 to 64 years of age
* ICD-10 diagnosis of a current or previous mental or behavioral disorder (F20-F69, F84, F90-95)
* For the diagnoses F84 and F90 a previous period of treatment with melatonin is required
* For the 16-17 years old: Non-pharmacological treatment options inc…
Contacts