Sleep Initiation and Maintenance DisordersNCT05753943
CLINICAL TRIAL PHASE II, MULTICENTRIC, NATIONAL, DOUBLE-BLIND, PARALLEL, RANDOMIZED, AND PLACEBO-CONTROLLED FOR EVALUATION OF THE IMPROVEMENT OF SLEEP QUALITY IN PARTICIPANTS OF RESEARCH WITH INSOMNIA DISORDER
A study testing QUALI in people with Sleep Initiation and Maintenance Disorders, run by Federal University of São Paulo.
Trial summary
QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Sleep Initiation and Maintenance Disorders
- What is being tested?
- QUALI
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Agreement to participate in the study, documented through the signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.
Who cannot join
- Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.
- Research participants with a history of thyroid dysfunction significant or uncontrolled. Taking the following CNS depressant drugs: Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.
About this study
QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02.
Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period.
Read more
Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index.
A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy.
Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment.
Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system.
Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system.
Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder.
Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests.
Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.
Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.
Research participants with a history of thyroid dysfunction significant or uncontrolled.
Taking the following CNS depressant drugs:
Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.
Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.
Read the detailed description
QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02.
Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period.
Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index.
A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy.
Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment.
Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system.
Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system.
Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder.
Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests.
Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.
Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.
Research participants with a history of thyroid dysfunction significant or uncontrolled.
Taking the following CNS depressant drugs:
Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.
Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.
- Being tested
- QUALI
- Keywords
- insomnia, sleep initiation disorder, sleep maintenance disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QUALIDrug
Also called QUALI 50, QUALI 75
Medication 1 pill at night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Sleep Initiation and Maintenance DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Fernando Morgadinho Santos Coelho, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753943
- Sponsor's protocol ID
- 0001
- Status last verified
- Feb 2023
- First submitted
- 23 Feb 2023
- Last updated
- 3 Mar 2023
- Results posted
- No
Publications
Arriaga F, Cavaglia F, Pires AM, Lam E, Paiva T. Effects of trazodone on insomnia and anxiety in depressed patients: a clinical and sleep EEG study. Int J Psychiatry Clin Pract. 1997;1(4):281-6. doi: 10.3109/13651509709024740.
PubMed 24946195Ather SA, Ankier SI, Middleton RS. A double-blind evaluation of trazodone in the treatment of depression in the elderly. Br J Clin Pract. 1985 May;39(5):192-9. No abstract available.
PubMed 3907684Blacker R, Shanks NJ, Chapman N, Davey A. The drug treatment of depression in general practice: a comparison of nocte administration of trazodone with mianserin, dothiepin and amitriptyline. Psychopharmacology (Berl). 1988;95 Suppl:S18-24. doi: 10.1007/BF00172625.
PubMed 3133708Botros WA, Ankier SI, Priest RG, McManus IC, Steinert J, Samir ZY. Clinical assessment and performance tasks in depression: a comparison of amitriptyline and trazodone. Br J Psychiatry. 1989 Oct;155:479-82. doi: 10.1192/bjp.155.4.479.
PubMed 2692763Eraslan D, Ertekin E, Ertekin BA, Ozturk O. Treatment of insomnia with hypnotics resulting in improved sexual functioning in post-menopausal women. Psychiatr Danub. 2014 Dec;26(4):353-7.
PubMed 25377370Khazaie H, Ghadami MR, Knight DC, Emamian F, Tahmasian M. Insomnia treatment in the third trimester of pregnancy reduces postpartum depression symptoms: a randomized clinical trial. Psychiatry Res. 2013 Dec 30;210(3):901-5. doi: 10.1016/j.psychres.2013.08.017. Epub 2013 Aug 30.
PubMed 23993464
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CLINICAL TRIAL PHASE II, MULTICENTRIC, NATIONAL, DOUBLE-BLIND, PARALLEL, RANDOMIZED, AND PLACEBO-CONTROLLED FOR EVALUATION OF THE IMPROVEMENT OF SLEEP QUALITY IN PARTICIPANTS OF RESEARCH WITH INSOMNIA DISORDER
- ClinicalTrials.gov ID
- NCT05753943
- Acronym / sponsor ID
- 0001
- Keywords
- insomnia, sleep initiation disorder, sleep maintenance disorder
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- First posted
- 3 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02.
Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period.
Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index.
A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy.
Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment.
Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system.
Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system.
Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder.
Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests.
Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.
Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.
Research participants with a history of thyroid dysfunction significant or uncontrolled.
Taking the following CNS depressant drugs:
Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.
Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.
Detailed description
QUALI-001 code Phase II. Multicentric type. Test Product (QUALI-50) and (QUALI-75). Control Placebo capsule Primary goal Evaluate the improvement in sleep quality through the evaluation comparison of Pittsburgh Sleep Quality Index Scale scores obtained in visit 04 (final) compared to visit 02.
Evaluate the impact of treatments on improving sleep quality and total sleep time through actigraphic evaluation obtained through the average of the data observed in the last 07 days of treatment, compared to the average of the data observed in the 07 days of the basal period.
Outcome: A significant reduction in the score on the Scale is expected Pittsburgh Sleep Quality Index.
A significant increase in sleep efficiency is expected and a significant decrease in sleep latency time and the number of arousals evaluated through actigraphy.
Design Multicenter, randomized, placebo-controlled, parallel, with three treatments, in which each patient will receive treatment.
Arm 01: Control Treatment: Sleep Hygiene + Basic Medications + Placebo Arm 02: Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system.
Arm 03: Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system.
Population Research participants of both sexes, diagnosed with Moderate or severe insomnia disorder.
Control Treatment: Sleep Hygiene + Basic Medications + Placebo Treatment Test 1: Sleep hygiene + Basic drugs + (QUALI-50) capsule with the biphasic delivery system Treatment Test 2: Sleep Hygiene + Basic Medications+ (QUALI-75) capsule with the biphasic delivery system Reviews of efficiency Sleep quality scales, actigraphic measures, and sleep diary sleep. Reviews of security Clinical examination, monitoring of adverse events, electrocardiogram, and laboratory tests.
Criteria of Inclusion Agreement to participate in the study, documented through signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.
Criteria of Exclusion Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.
Research participants with a history of thyroid dysfunction significant or uncontrolled.
Taking the following CNS depressant drugs:
Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.
Size of sample: Inclusion of approximately 99 research participants, divided into 3 parallel arms.
Study design
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Agreement to participate in the study, documented through the signature of the TCLE. Research participants diagnosed with Insomnia Disorder moderate or severe (≥ 10 points on the Pittsburgh scale). Stable research participant with outpatient treatment for Insomnia disorder for at least 60 days from visit 01 (initial). Age above 40 years. Research participants of both genders. Research participants were able to understand and provide their consent and complete the sleep diary and scales. Research participants with the ability to handle the actigraph properly. Women of childbearing age should accept the use of contraception during the study period. Men should accept the use of barrier contraceptives during the study period.
Key exclusion criteria (2 listed)
- Research participants who are using drugs like benzodiazepines or other anxiolytics that may induce/alter sleep. Research participant having made previous use of Trazodone for less than 90 days from visit 01 (initial). Research participants having used MAOIs during a period of up to 30 days from visit 01 (initial). Research participants using barbiturates. Research participants using Linezolid for up to 30 days from visit 01 (initial). Research participants with a history of hypersensitivity to drugs. Research participants with a history of prolonged erection or priapism, abnormal orgasm, urinary incontinence, retention urinary tract, erectile dysfunction, retrograde ejaculation, clitorism, hematuria, and pollakiuria. Research Participants with a History of Beverage Addiction alcohol at the discretion of the investigator. Research participants with a history of clinical disease at the discretion of the investigator may confound the study results or are significant for the safety of the research participant. Pregnant or breastfeeding women. Research participants with a history of psychiatric illness serious or uncontrolled may influence the ability of the research participant to respond to the procedures of the study. Research participants with a significant history of hypotension. Research participants with a history of angle-closure glaucoma closed, photophobia, diplopia, xerophthalmia, and eye pain.
- Research participants with a history of thyroid dysfunction significant or uncontrolled. Taking the following CNS depressant drugs: Carbamazepine, Buprenorphine/opioids, Inducing substrates or CYP3A4 inhibitors, Digoxin, phenytoin, Warfarin. Participants with prostatic hyperplasia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QUALIAlso: QUALI 50, QUALI 75Medication 1 pill at night | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2023.
- Background: PubMed 24946195Arriaga F, Cavaglia F, Pires AM, Lam E, Paiva T. Effects of trazodone on insomnia and anxiety in depressed patients: a clinical and sleep EEG study. Int J Psychiatry Clin Pract. 1997;1(4):281-6. doi: 10.3109/13651509709024740.
- Background: PubMed 3907684Ather SA, Ankier SI, Middleton RS. A double-blind evaluation of trazodone in the treatment of depression in the elderly. Br J Clin Pract. 1985 May;39(5):192-9. No abstract available.
- Background: PubMed 3133708Blacker R, Shanks NJ, Chapman N, Davey A. The drug treatment of depression in general practice: a comparison of nocte administration of trazodone with mianserin, dothiepin and amitriptyline. Psychopharmacology (Berl). 1988;95 Suppl:S18-24. doi: 10.1007/BF00172625.
- Background: PubMed 2692763Botros WA, Ankier SI, Priest RG, McManus IC, Steinert J, Samir ZY. Clinical assessment and performance tasks in depression: a comparison of amitriptyline and trazodone. Br J Psychiatry. 1989 Oct;155:479-82. doi: 10.1192/bjp.155.4.479.
- Background: PubMed 25377370Eraslan D, Ertekin E, Ertekin BA, Ozturk O. Treatment of insomnia with hypnotics resulting in improved sexual functioning in post-menopausal women. Psychiatr Danub. 2014 Dec;26(4):353-7.
- Background: PubMed 23993464Khazaie H, Ghadami MR, Knight DC, Emamian F, Tahmasian M. Insomnia treatment in the third trimester of pregnancy reduces postpartum depression symptoms: a randomized clinical trial. Psychiatry Res. 2013 Dec 30;210(3):901-5. doi: 10.1016/j.psychres.2013.08.017. Epub 2013 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing QUALI in people with Sleep Initiation and Maintenance Disorders, run by Federal University of São Paulo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05753943, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2023; AzTrials last refreshed its copy on 30 Oct 2026.