Melatonin 3mg and 5mg Compared to Cognitive Behavioral Therapy for Insomnia (CBT-I) in the Treatment of Insomnia

NCT02798367 | Unknown Phase 2

• 1 other identifier: ACH-MSZ-02-03(05/16)
• Study Type: interventional
• Target: 307
• Locations: 1 country
• Sites: 8

Brief Summary

National clinical trials, phase II/III, combined in two stages, randomized, double-blind, controlled, parallel, study of superiority, in which three hundred and seven (307) participants of both sexes, aged equal or more than 55 years will be randomly allocated to one of three treatment groups. In the first stage. The group 01 will use Melatonin 3mg plus CBT-I, the group 02 will use Melatonin 5mg plus CBT-I and the group 03 will use CBT-I plus placebo. Based on the results of an interim analysis will be making a decision on whether to proceed with the study and, if so, on which the doses will be selected for the second stage of the study, to be better studied. The final analysis of the treatments, melatonin in the selected dose plus CBT-I versus CBT-I alone and placebo, will include participants from both stages.

Conditions

Insomnia Disorder

Keywords

insomnia; cognitive behavioral therapy for insomnia; melatonin

Outcome Measures

Primary Outcomes (1)

• Change of Sleep Latency after 21 (±2) days of the treatment.

  Absolute change in sleep latency (in minutes) at the end of treatment compared to baseline. Sleep latency will be assessed by polysomnography.

  21 (±2) days

Secondary Outcomes (9)

• Quality of Sleep - Pittsburgh Sleep Quality Index

  21 (±2) days

• Wellness Day - Well-Being Index-5 (WHO-5)

  21 (±2) days

• Severity of Insomnia - Insomnia Severity Index

  21 (±2) days

• Total Sleep Time - Polysomnography

  21 (±2) days

• Sleep Architecture - the length and proportion of N1(non-rapid eyes movement) stages, N2, N3 and REM

  21 (±2) days

Study Arms (3)

CBT-I plus Melatonin 3 mg

EXPERIMENTAL

It's a tablet manufactured by Aché S.A., composed of melatonin 3mg. Melatonin 3mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days. CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol.

Behavioral: CBT-I plus placebo; Drug: CBT-I plus Melatonin 3 mg

CBT-I plus Melatonin 5 mg

EXPERIMENTAL

It's a tablet manufactured by Aché S.A., composed of melatonin 5mg. Melatonin 5mg tablet will be dispensed to 65 participants (first stage) of this group in a cartridge of 3 blisters with 10 tablets each, totalizing 30 tablets. If this arm is the best set for the second stage, more 56 participants will be randomly allocated in this group.The participant shall administer 01 tablet orally every 24 hours one hour before bedtime. The duration of treatment may be 21(±2) days. CBT-I is a non-pharmacological effective treatment for insomnia disorder. Behavioral techniques of Sleep Hygiene and Stimuli control are the most used. The CBT-I guidelines are standardized in protocol.

Behavioral: CBT-I plus placebo; Drug: CBT-I plus Melatonin 5 mg

CBT-I plus placebo

OTHER

It's a tablet manufactured by Aché S.A,. composed of placebo. The participants shall administer the placebo tablets to enable the double-blind study. Placebo will be dispensed to 65 (first stage) and 56 (second stage) participants of this group and shall administer 01 tablet orally every 24 hours one hour before bedtime for 21(±2) days. Sleep hygiene is a psychoeducational intervention that teaches patients to prevent external or environmental factors generate adverse effects and harmful to sleep. The stimulus control technique is based on five instructions that encourages the patient to establish a proper sleep-wake rhythm and strengthens the links between the way for a quick and well consolidated sleep. The CBT-I guidelines are standardized in clinical protocol.

Behavioral: CBT-I plus placebo

Interventions

CBT-I plus placebo BEHAVIORAL

Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus placebo (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days)

CBT-I plus Melatonin 3 mg; CBT-I plus Melatonin 5 mg; CBT-I plus placebo

CBT-I plus Melatonin 3 mg DRUG

Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 3 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.

Also known as: Melatonin

CBT-I plus Melatonin 3 mg

CBT-I plus Melatonin 5 mg DRUG

Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 5 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.

Also known as: Melatonin

CBT-I plus Melatonin 5 mg

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fulfill the criteria for insomnia disorder, according to DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, 5th Edition);
• Complaint of difficulty falling asleep;
• Ability to understand and consent their participation in this clinical study, expressed by signing the Informed Consent Form (ICF).

You may not qualify if:

• Known hypersensitivity to drug components used during the study;
• Participant have any family relationship to the second degree or bond with employees or employees of Sponsor and Sites;
• Participant has used beta-blockers (in the last 30 days prior to screening visit), psychoactive drugs or sedative effect, such as, but not limited to: sedatives (in the last 14 days prior to screening visit), hypnotics (in the last 07 days prior to screening visit), muscle relaxants (in the last 11 days prior to screening visit), antihistamines first generation (in the last 08 days prior to screening visit), and antidepressants, antiepileptics, antipsychotics, among others (in the last 30 days prior to screening visit);
• Participants diagnosed with clinical diseases that interfere with sleep, such as chronic pain, nocturia, hypothyroidism, hyperthyroidism, severe heart disease, serious neurological and psychiatric disorders according to the assessment of the investigator;
• Participants diabetics insulin dependent;
• Sleep apnea moderate to severe - AHI \> 20 (Apnoea-Hypopnoea Index) assessed by polysomnography at the baseline;
• Participants who work at night;
• Participant who has BMI ≥ 30;
• Participant score above 50 in Anxiety Inventory to assess the degree of anxiety;
• Participant with cognitive impairment, based on the result obtained in the Mini-Mental State Examination. The cognitive impairment will be considered with score below 13 points for illiterates, below 18 for participants with one to eight incomplete years of schooling, below 26 for those with education of eight or more years;
• Participant score above 20 on the Beck Inventory to assess depression;
• Abuse of alcohol or illicit drugs, according to the assessment of the investigator;
• Male participants who do not agree to use acceptable methods of contraception; 1) male participants: barrier methods, except surgically sterile (vasectomy) or participants who declare to perform sexual practices on a not to reproductive way. 2) methods of contraception for the male participant's partner: oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, hormonal patch, tubal ligation and barrier methods; except surgically sterile (bilateral oophorectomy or hysterectomy) or the menopausal for at least one year;
• Female participants who are in the reproductive age and do not agree to use acceptable methods of contraception (oral contraceptives, injectable contraceptives, intrauterine device (IUD), hormonal implants, barrier methods, hormonal patch and tubal ligation); except surgically sterile (bilateral oophorectomy or hysterectomy), the menopausal for at least one year and participants who declare to perform sexual practices on a not to reproductive way;
• Women in gestation period or who are breastfeeding;

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

Study Sites (8)

CEDOES - Centro de Diagnóstico e Pesquisa da Osteoporose do Espirito Santo.

Vitória, Espírito Santo, 29055-450, Brazil

RECRUITING

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

TERMINATED

Allergisa Pesquisa Dermato Cosmética Ltda.

Campinas, São Paulo, Brazil

RECRUITING

Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto USP

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Centro de Estudos Multidisciplinar CEPES da Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

TERMINATED

Dr Consulta Clinica Medica Ltda

São Paulo, 01141-020, Brazil

RECRUITING

Centro Paulista de Investigação Clínica e Serviços Médicos Ltda.

São Paulo, 04266-010, Brazil

TERMINATED

Centro de Desenvolvimento em Estudo Clínicos Brasil - CDEC Brasil

São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Interventions

Melatonin

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Mauro Crippa Jr.

  Allergisa Search Dermato Cosmetic Ltda.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisangela Rorato

CONTACT

+55 11 2608-6130; elisangela.rorato@ache.com.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 14, 2016
• Study Start: March 22, 2018
• Primary Completion: October 31, 2021
• Study Completion: November 30, 2021
• Last Updated: September 3, 2020

Record last verified: 2020-09

Locations

BR (8)