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melatonin + amitriptyline
- Development stage
- Phase 3
- Lead developer
- Hospital de Clínicas de Porto Alegre
- Modality
- Small Molecules
- Administration
- Oral
01
Overview
Melatonin + amitriptyline is an investigational combination therapy being studied by the Hospital de Clínicas de Porto Alegre for the treatment of fibromyalgia. Melatonin (10 mg) is a hormone that regulates circadian rhythms and acts on the endogenous pain-modulating system, while amitriptyline (25 mg) is a tricyclic antidepressant that inhibits the reuptake of serotonin and noradrenaline, enhancing descending inhibitory pain pathways. This combination aims to synergistically improve both pain and sleep disturbances associated with fibromyalgia. A Phase II clinical trial (NCT02041455) evaluated its efficacy in female patients, finding that while the combination was superior to amitriptyline alone, it offered only marginal additional clinical benefits compared to melatonin monotherapy.
- Other names
- melatonin and amitriptylinemelatonin plus amitriptylinemelatonin and amitriptylin
02
Targets
MTNR1A (MT1)NET (Norepinephrine Transporter)SERT (Sodium-dependent serotonin transporter)NTRK1 (Tropomyosin-related receptor kinase A)NTRK2 (Tropomyosin-related kinase receptor type B)
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