Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Phase II Role of Immune-pineal Axis in Fibromyalgia: Noradrenergic Modulation and Chronotherapeutic Aspects
Brief Summary: Fibromyalgia is a common condition in clinical medical practice, characterized by diffuse musculoskeletal pain. Sleep disorders, chronic fatigue, depression, intestinal disorders and headache are also commonly associated with the syndrome .

Although the etiology of this syndrome is not well defined yet, it means involve multiple mechanisms, including low levels of serotonin, increased substance P in cerebrospinal fluid and altered circadian variation in sympathetic - parasympathetic balance, consistent with changes in sympathetic hyperactivity at night .

The immune - pineal system, formed by the integration of the adrenergic and immune systems pineal gland, appears to be involved in the genesis of the dysfunctions found in fibromyalgia. Melatonin is secreted by the pineal gland and has promoter activity of sleep. Studies show that melatonin and its precursors , serotonin and tryptophan are reduced in patients with fibromyalgia.

The present study aims to evaluate the relationship of immune - pineal system in the process of fibromyalgia , since dysfunction of this axis appears to govern the cascading events that participate in the pathophysiological process of this disease.


Options:
A: Arm Label: Melatonin and Placebo; Type: EXPERIMENTAL; Interventions: Drug: Melatonin and Placebo | Arm Label: Amitriptyline and placebo; Type: EXPERIMENTAL; Interventions: Drug: Amitriptyline and Placebo | Arm Label: Melatonin and Amitriptylin; Type: ACTIVE_COMPARATOR; Interventions: Drug: Melatonin and Amitriptylin | Intervention Type: DRUG; Name: Melatonin and Placebo; Assigned to Arm(s): Melatonin and Placebo | Intervention Type: DRUG; Name: Amitriptyline and Placebo; Assigned to Arm(s): Amitriptyline and placebo | Intervention Type: DRUG; Name: Melatonin and Amitriptylin; Assigned to Arm(s): Melatonin and Amitriptylin
B: Arm Label: 1; Type: EXPERIMENTAL; Interventions: Drug: pregabalin | Arm Label: 2; Type: EXPERIMENTAL; Interventions: Drug: pregabalin | Arm Label: 3; Type: EXPERIMENTAL; Interventions: Drug: pregabalin | Arm Label: 4; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): 1 | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): 2 | Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): 3 | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): 4
C: Intervention Type: DRUG; Name: pregabalin; Assigned to Arm(s): N/A | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): N/A
D: Arm Label: A; Type: EXPERIMENTAL; Interventions: Drug: Pregabalin | Arm Label: B; Type: EXPERIMENTAL; Interventions: Drug: Pregabalin | Arm Label: C; Type: EXPERIMENTAL; Interventions: Drug: Pregabalin | Arm Label: D; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): B | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): A | Intervention Type: DRUG; Name: Pregabalin; Assigned to Arm(s): C | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): D

Answer: A