Depressive Disorder, MajorNCT03721588
Clinical and Suicidal Features of Urban, Turkish Middle Age Depressive Patients With Comorbid ADHD
An observational study of Depressive Disorder, Major and Adult Attention Deficit Hyperactivity Disorder, run by Bozyaka Training and Research Hospital.
Trial summary
In the presence of attention deficit hyperactivity disorder (ADHD) together with additional psychiatric diseases, the treatment process and prognosis of both ADHD and psychiatric comorbidity are adversely affected. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Disorder, Major, Adult Attention Deficit Hyperactivity Disorder, Suicide
- What is being tested?
- Clinical interviews, psychometric scales were applied.
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2015to 1 Sep 2017
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Study population: inpatiets with diagnosis of major depressive disorder
Who may be able to join
- Complying with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth) criteria for major depression
- Hamilton Depression Scale (HDRS) being over 16 points during hospitalization
Who cannot join
- Mental retardation
- Psychotic disorder
- Alcohol or substance addiction
- History of head trauma
- Being under psychostimulant treatment
About this study
Official title: Evaluation of Clinical and Suicidal Behavior Characteristics Among Urban, Turkish Middle-Age Depressive Patients With Comorbid Adult Attention Deficit Hyperactivity Disorder
In the presence of attention deficit hyperactivity disorder (ADHD) together with additional psychiatric diseases, the treatment process and prognosis of both ADHD and psychiatric comorbidity are adversely affected. The aim of this study is to compare the characteristics concerning the suicidal behavior of the patients with major depressive disorder (MDD) who have (ADHD+) or do not have (ADHD-) adult ADHD comorbidity and their responses to depression treatment. 96 inpatients were included in the study. Socio-demographic data form, Hamilton Depression Scale (HDRS), Wender Utah Rating Scale (WURS), Adult ADD/ADHD DSM IV- Based Diagnostic Screening and Rating Scale (A-ADHD), Personal and Social Performance Scale (PSP) were applied to the cases. In the study, depression starts at an early age in individuals with comorbid ADHD and the depression treatment progress changes negatively. This group of patients is at greater risk in terms of suicidal behavior. For these reasons, clinicians should be careful during ADHD and depression management in adults.
Read the detailed description
Suicidal behavior is a serious cause of mortality and morbidity in terms of psychiatric diseases. Suicidal ideation and suicide attempts that do not result in death cause many social and emotional problems, but they are the most important risk factors for the next suicide attempt and death resulting from suicide.[1,2] It has been reported that 90% of the completed suicide attempt cases are accompanied by a psychiatric disease and depressive disorders are seen at a highest level. [3] Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder with symptoms of inattention, hyperactivity and impulsivity that is seen as of childhood.[4-6] ADHD disrupts the individuals' functionality in many fields such as academic, social and business life.[7] It also increases the risk of comorbidity of many psychiatric diseases.[8-10] In the studies carried out, it has been reported that depression is seen in rates ranging from 16% to 31% in cases with adult ADHD [11] and it was accompanied by ADHD in 15% of cases with depression.[12] In depressive adults with ADHD comorbidity, resistance to depression treatment develops and the longitudinal progress of both diseases is adversely affected.[13-14] In the literature review, it has been reported that suicide risk increased in children,[15] in university students,[16] in young women,[17] in ADHD and depression comorbidity and the clinical progress of depression was adversely affected.[18] Studies examining the relationship of suicide in ADHD and depression comorbidity in adults have been mostly carried out in young adults and it has been suggested by researchers to investigate the association of ADHD and depression in older adults.[19-22] The aim of this study was to compare the suicidal behavior, the onset age of depression and the respond to the treatment of the depressive disorder inpatients in the psychiatry service who are with and without comorbid ADHD. Hypothesis of this study is that the following will be observed in the adult depression patients with ADHD comorbidity; depression starting at an earlier age, having much more suicide attempts (number of suicide attempts in the past) that are much serious (requiring medical treatment) and having more severe depression (depression scale scores) and worse self-functionality during discharge from the hospital.
Material \& Methods Complying with DSM-IV criteria and Hamilton Depression Scale (HDRS) being over 16 points during hospitalization have been determined to be the criteria for inclusion in the research. In total, 96 patients were included in the study. All cases were interviewed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).[23] Other comorbid psychiatric disorders were excluded. Adult ADHD diagnosis has been confirmed by two different researchers for each case (DHD, EE). In the retrospective investigation of ADHD diagnosis, cases who got the score of 36 and above in the Wender Utah Rating Scale (WURS) have been included in the study.
Investigators evaluated suicidal behavior in a similar manner to the methods used in some previous studies.[20,24,25] In the sociodemographic data form, suicidal ideation in the past (Have you ever thought about ending your life before? / Yes or No), suicide attempt (Have you ever attempted suicide before? / Yes or No) and number of suicide attempts have been recorded. Material
Socio-demographic data form:
Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) [26] Hamilton Depression Rating Scale (HDRS): [28] Adult ADD/ADHD DSM IV- Based Diagnostic Screening and Rating Scale (A-ADHDS) has been developed by Atilla Turgay in Canada.[29,30] Wender Utah Rating Scale (WURS): [31,32] Personal and Social Performance Scale (PSP): [33,34] Statistical analysis: SPSS Statistics Version 22.0 has been used for data analysis. The distribution characteristics of the variables have been evaluated by using the Shapiro-Wilk test. Student-t test has been used to compare normal distribution parameters and Mann-Whitney U test has been used for abnormal distribution parameters. According to the ADHD comorbidity, suicide attempt has been compared with the Pearson chi-squared test. P values below 0.05 have been considered to be statistically significant results.
Results The mean age of the patients was 39.1±10.4. 57% (n=55) of all patients were females. 31% (n=30) were single / never married, 53% (n=49) were married / living with a spouse, 16% (n=17) were divorced or living apart There was no statistically significant difference found between patients with ADHD comorbidity (ADHD+) and patients with only MDD (ADHD-) in terms of gender, age, marital status and education.
In the ADHD+ group, depression started at an earlier age than the ADHD- group (p= .011). The average HDRS scores during admission to hospital and discharge from the hospital were significantly higher in the ADHD+ group (p<.000). Moreover, the average PSP scores of the ADHD+ group at admission to hospital was lower than the ADHD- group and there was a statistically significant difference between them (p = .002). There was no difference between the groups during their discharge with regards to PSP scores (p = .46).
Suicidal ideation (p = .018) and suicide attempts (p = .013) throughout life were higher in the ADHD+ group than the ADHD- group. In the ADHD+ group, the rate of suicide attempts that require medical intervention was higher (p = .001). A comparison of the suicidal behavior characteristics of ADHD+ and ADHD- groups is presented in Table 3 and it has been shown graphically whether the cases have attempted suicide according to ADHD comorbidity throughout their lives.
Discussion n ADHD+ group, depression has started at an earlier age, the severity of depression has been higher during discharge from the hospital and suicidal ideation, number of suicide attempts and suicide attempts requiring medical intervention throughout their lives were found to be high. Depressive disorder patients with ADHD comorbidity in our study have got their first depression diagnosis at an early age. Similar results have been found by other researchers.[17,35, 36] Another result of study was that the discharge HDRS scores of the depressive patients with ADHD comorbidity were higher. Resistance to depression treatment has been reported in the association of ADHD and depression.[38,39] ADHD causes disruptions of the individuals' functionality in many areas of their lives starting from childhood [40,41] and it has also been reported that there is a decrease in social skills and self-esteem of adolescents with ADHD.[42] It has been suggested that in the event of frequent recurrent depressive attacks, inability of remission, continuation of residual symptoms and inadequate response to classical therapies of cases with depression, a retrospective investigation of ADHD[38,39] and treatment planning for ADHD should be made.[18,36,43] As a result of the study, the rate of suicidal ideation throughout life and number of suicide attempts were found to be higher in ADHD+ group. As mentioned literature, 90% of the cases who attempted suicide are accompanied by a psychiatric disorder where depressive disorder is the most common one.[3] It has been reported that suicide attempts are related to depression duration or impulsivity.[43] In addition, as a result of the research, in the association of ADHD and depression, the number of suicidal behaviors that are serious enough to require medical care is also higher. This finding has also been reported by other researchers when literature is evaluated.[16,25] In adults, suicide is more common in ADHD and MDD comorbidity and suicidal attempts may lead to more dangerous consequences (such as being in the intensive care unit, causing disability).
- Being tested
- Clinical interviews, psychometric scales were applied.
- Medical subject headings
- Depressive Disorder, Major, Attention Deficit Disorder with Hyperactivity, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical interviews, psychometric scales were applied.Other
| Study group | Role | What they receive |
|---|---|---|
| Major depressive disorder | MDD; patients with diagnosis of major depressive disorder, Clinical interviews, psychometric scales were applied. Receives: Other: Clinical interviews, psychometric scales were applied. | |
| MDD and ADHD | MDD; major depressive disorder ADHD; attention deficit hyperactivity disorder, Clinical interviews, psychometric scales were applied. Receives: Other: Clinical interviews, psychometric scales were applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
depressive inpatients with comorbid ADHD (n=48) and without comorbid ADHD (n=48) were compared according to the suicidal behavior, the onset age of depression, the response to the treatment, and psychosocial functioning.
Clinical interviews, psychometric scales such as, Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), Hamilton Depression Rating Scale (HDRS), Adult ADD/ADHD DSM IV- Based Diagnostic Screening and Rating Scale (A-ADHDS), Wender Utah Rating Scale (WURS), Personal and Social Performance Scale (PSP) were applied. 96 inpatients were included in the study. In our study, depression starts at an early age in individuals with comorbid ADHD and the depression treatment progress changes negatively. This group of patients is at greater risk in terms of suicidal behavior.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start1 Sep 2015
- Primary completion1 Jun 2017
- Study completion1 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esin Erdoğan, Bozyaka Training and Research Hospital
- Investigators
- Esin Erdogan, MD, Principal investigator, Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03721588
- Sponsor's protocol ID
- dresinerdogan
- Status last verified
- Oct 2018
- First submitted
- 12 Oct 2018
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Duran S, Fistikci N, Keyvan A, Bilici M, Caliskan M. [ADHD in adult psychiatric outpatients: prevalence and comorbidity]. Turk Psikiyatri Derg. 2014 Summer;25(2):84-93. Turkish.
PubMed 24936755Agosti V, Chen Y, Levin FR. Does Attention Deficit Hyperactivity Disorder increase the risk of suicide attempts? J Affect Disord. 2011 Oct;133(3):595-9. doi: 10.1016/j.jad.2011.05.008. Epub 2011 Jun 11.
PubMed 21658780Tamam L, Demirkol ME. Adult attention deficit/hyperactivity disorder and mood disorders. Turkiye Klin J Psychiatry-Special Top 2012;5:48-3.
Ekinci S, Öncü B, Canat S. Adult attention deficit hyperactivity disorder: comorbidity and functioning. Anadolu Psikiyatr Derg 2011;12:185-1.
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical and Suicidal Behavior Characteristics Among Urban, Turkish Middle-Age Depressive Patients With Comorbid Adult Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT03721588
- Acronym / sponsor ID
- dresinerdogan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Sep 2015 (actual)
- Primary completion
- 1 Jun 2017 (actual)
- Study completion
- 1 Sep 2017 (actual)
- First posted
- 26 Oct 2018 (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.
In the presence of attention deficit hyperactivity disorder (ADHD) together with additional psychiatric diseases, the treatment process and prognosis of both ADHD and psychiatric comorbidity are adversely affected. The aim of this study is to compare the characteristics concerning the suicidal behavior of the patients with major depressive disorder (MDD) who have (ADHD+) or do not have (ADHD-) adult ADHD comorbidity and their responses to depression treatment. 96 inpatients were included in the study. Socio-demographic data form, Hamilton Depression Scale (HDRS), Wender Utah Rating Scale (WURS), Adult ADD/ADHD DSM IV- Based Diagnostic Screening and Rating Scale (A-ADHD), Personal and Social Performance Scale (PSP) were applied to the cases. In the study, depression starts at an early age in individuals with comorbid ADHD and the depression treatment progress changes negatively. This group of patients is at greater risk in terms of suicidal behavior. For these reasons, clinicians should be careful during ADHD and depression management in adults.
Detailed description
Suicidal behavior is a serious cause of mortality and morbidity in terms of psychiatric diseases. Suicidal ideation and suicide attempts that do not result in death cause many social and emotional problems, but they are the most important risk factors for the next suicide attempt and death resulting from suicide.[1,2] It has been reported that 90% of the completed suicide attempt cases are accompanied by a psychiatric disease and depressive disorders are seen at a highest level. [3] Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder with symptoms of inattention, hyperactivity and impulsivity that is seen as of childhood.[4-6] ADHD disrupts the individuals' functionality in many fields such as academic, social and business life.[7] It also increases the risk of comorbidity of many psychiatric diseases.[8-10] In the studies carried out, it has been reported that depression is seen in rates ranging from 16% to 31% in cases with adult ADHD [11] and it was accompanied by ADHD in 15% of cases with depression.[12] In depressive adults with ADHD comorbidity, resistance to depression treatment develops and the longitudinal progress of both diseases is adversely affected.[13-14] In the literature review, it has been reported that suicide risk increased in children,[15] in university students,[16] in young women,[17] in ADHD and depression comorbidity and the clinical progress of depression was adversely affected.[18] Studies examining the relationship of suicide in ADHD and depression comorbidity in adults have been mostly carried out in young adults and it has been suggested by researchers to investigate the association of ADHD and depression in older adults.[19-22] The aim of this study was to compare the suicidal behavior, the onset age of depression and the respond to the treatment of the depressive disorder inpatients in the psychiatry service who are with and without comorbid ADHD. Hypothesis of this study is that the following will be observed in the adult depression patients with ADHD comorbidity; depression starting at an earlier age, having much more suicide attempts (number of suicide attempts in the past) that are much serious (requiring medical treatment) and having more severe depression (depression scale scores) and worse self-functionality during discharge from the hospital.
Material \& Methods Complying with DSM-IV criteria and Hamilton Depression Scale (HDRS) being over 16 points during hospitalization have been determined to be the criteria for inclusion in the research. In total, 96 patients were included in the study. All cases were interviewed with the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I).[23] Other comorbid psychiatric disorders were excluded. Adult ADHD diagnosis has been confirmed by two different researchers for each case (DHD, EE). In the retrospective investigation of ADHD diagnosis, cases who got the score of 36 and above in the Wender Utah Rating Scale (WURS) have been included in the study.
Investigators evaluated suicidal behavior in a similar manner to the methods used in some previous studies.[20,24,25] In the sociodemographic data form, suicidal ideation in the past (Have you ever thought about ending your life before? / Yes or No), suicide attempt (Have you ever attempted suicide before? / Yes or No) and number of suicide attempts have been recorded. Material
Socio-demographic data form:
Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I) [26] Hamilton Depression Rating Scale (HDRS): [28] Adult ADD/ADHD DSM IV- Based Diagnostic Screening and Rating Scale (A-ADHDS) has been developed by Atilla Turgay in Canada.[29,30] Wender Utah Rating Scale (WURS): [31,32] Personal and Social Performance Scale (PSP): [33,34] Statistical analysis: SPSS Statistics Version 22.0 has been used for data analysis. The distribution characteristics of the variables have been evaluated by using the Shapiro-Wilk test. Student-t test has been used to compare normal distribution parameters and Mann-Whitney U test has been used for abnormal distribution parameters. According to the ADHD comorbidity, suicide attempt has been compared with the Pearson chi-squared test. P values below 0.05 have been considered to be statistically significant results.
Results The mean age of the patients was 39.1±10.4. 57% (n=55) of all patients were females. 31% (n=30) were single / never married, 53% (n=49) were married / living with a spouse, 16% (n=17) were divorced or living apart There was no statistically significant difference found between patients with ADHD comorbidity (ADHD+) and patients with only MDD (ADHD-) in terms of gender, age, marital status and education.
In the ADHD+ group, depression started at an earlier age than the ADHD- group (p= .011). The average HDRS scores during admission to hospital and discharge from the hospital were significantly higher in the ADHD+ group (p<.000). Moreover, the average PSP scores of the ADHD+ group at admission to hospital was lower than the ADHD- group and there was a statistically significant difference between them (p = .002). There was no difference between the groups during their discharge with regards to PSP scores (p = .46).
Suicidal ideation (p = .018) and suicide attempts (p = .013) throughout life were higher in the ADHD+ group than the ADHD- group. In the ADHD+ group, the rate of suicide attempts that require medical intervention was higher (p = .001). A comparison of the suicidal behavior characteristics of ADHD+ and ADHD- groups is presented in Table 3 and it has been shown graphically whether the cases have attempted suicide according to ADHD comorbidity throughout their lives.
Discussion n ADHD+ group, depression has started at an earlier age, the severity of depression has been higher during discharge from the hospital and suicidal ideation, number of suicide attempts and suicide attempts requiring medical intervention throughout their lives were found to be high. Depressive disorder patients with ADHD comorbidity in our study have got their first depression diagnosis at an early age. Similar results have been found by other researchers.[17,35, 36] Another result of study was that the discharge HDRS scores of the depressive patients with ADHD comorbidity were higher. Resistance to depression treatment has been reported in the association of ADHD and depression.[38,39] ADHD causes disruptions of the individuals' functionality in many areas of their lives starting from childhood [40,41] and it has also been reported that there is a decrease in social skills and self-esteem of adolescents with ADHD.[42] It has been suggested that in the event of frequent recurrent depressive attacks, inability of remission, continuation of residual symptoms and inadequate response to classical therapies of cases with depression, a retrospective investigation of ADHD[38,39] and treatment planning for ADHD should be made.[18,36,43] As a result of the study, the rate of suicidal ideation throughout life and number of suicide attempts were found to be higher in ADHD+ group. As mentioned literature, 90% of the cases who attempted suicide are accompanied by a psychiatric disorder where depressive disorder is the most common one.[3] It has been reported that suicide attempts are related to depression duration or impulsivity.[43] In addition, as a result of the research, in the association of ADHD and depression, the number of suicidal behaviors that are serious enough to require medical care is also higher. This finding has also been reported by other researchers when literature is evaluated.[16,25] In adults, suicide is more common in ADHD and MDD comorbidity and suicidal attempts may lead to more dangerous consequences (such as being in the intensive care unit, causing disability).
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Major depressive disorder | – | Other: Clinical interviews, psychometric scales were applied.MDD; patients with diagnosis of major depressive disorder, Clinical interviews, psychometric scales were applied. |
| MDD and ADHD | – | Other: Clinical interviews, psychometric scales were applied.MDD; major depressive disorder ADHD; attention deficit hyperactivity disorder, Clinical interviews, psychometric scales were applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- inpatiets with diagnosis of major depressive disorder
Key inclusion criteria (2 listed)
- Complying with DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth) criteria for major depression
- Hamilton Depression Scale (HDRS) being over 16 points during hospitalization
Key exclusion criteria (5 listed)
- Mental retardation
- Psychotic disorder
- Alcohol or substance addiction
- History of head trauma
- Being under psychostimulant treatment
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 |
|---|---|---|
| Clinical interviews, psychometric scales were applied. | Other | MDD and ADHD, Major depressive disorder |
Primary outcome
depressive inpatients with comorbid ADHD (n=48) and without comorbid ADHD (n=48) were compared according to the suicidal behavior, the onset age of depression, the response to the treatment, and psychosocial functioning.
Time frame: 2 years
Clinical interviews, psychometric scales such as, Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I), Hamilton Depression Rating Scale (HDRS), Adult ADD/ADHD DSM IV- Based Diagnostic Screening and Rating Scale (A-ADHDS), Wender Utah Rating Scale (WURS), Personal and Social Performance Scale (PSP) were applied. 96 inpatients were included in the study. In our study, depression starts at an early age in individuals with comorbid ADHD and the depression treatment progress changes negatively. This group of patients is at greater risk in terms of suicidal behavior.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Results publication: PubMed 24936755Duran S, Fistikci N, Keyvan A, Bilici M, Caliskan M. [ADHD in adult psychiatric outpatients: prevalence and comorbidity]. Turk Psikiyatri Derg. 2014 Summer;25(2):84-93. Turkish.
- Results publication: PubMed 21658780Agosti V, Chen Y, Levin FR. Does Attention Deficit Hyperactivity Disorder increase the risk of suicide attempts? J Affect Disord. 2011 Oct;133(3):595-9. doi: 10.1016/j.jad.2011.05.008. Epub 2011 Jun 11.
- Results publicationTamam L, Demirkol ME. Adult attention deficit/hyperactivity disorder and mood disorders. Turkiye Klin J Psychiatry-Special Top 2012;5:48-3.
- Results publicationEkinci S, Öncü B, Canat S. Adult attention deficit hyperactivity disorder: comorbidity and functioning. Anadolu Psikiyatr Derg 2011;12:185-1.
- Individual participant dataSharing planned: No
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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.
Esin Erdogan, MD principal investigator
Bozyaka Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Disorder, Major and Adult Attention Deficit Hyperactivity Disorder, run by Bozyaka Training and Research Hospital.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 30 Oct 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
What does the primary outcome measure?
depressive inpatients with comorbid ADHD (n=48) and without comorbid ADHD (n=48) were compared according to the suicidal behavior, the onset age of depression, the response to the treatment, and psychosocial functioning. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03721588, which also lists 4 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 30 Oct 2018.