Bipolar Disorder in RemissionNCT07857213
Seasonality, Chronotype, Impulsivity, and Suicidality in Mood Disorder Patients
An observational study of Bipolar Disorder in Remission and Major Depression in Remission, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study is to examine the seasonal variation of suicidal ideation in patients with mood disorders and the trajectory of impulsivity and suicidal ideation in patients with higher seasonality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder in Remission, Major Depression in Remission
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jun 2023to 1 Sep 2025
- 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
- No healthy volunteers
- Adult, Older adult
Study population: In this study, patients who consecutively applied to the outpatient clinic of Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Mental Health and Diseases between 01.09.2023 and 01.09.2024 and diagnosed with Bipolar Disorder or Unipolar Depression according to DSM-5 criteria will be included. It is planned to include at least 60 patients with each of these diagnoses in the study.
Who may be able to join
- To be willing and eager to participate in the study after reading and understanding the informed consent form
- Being diagnosed with Bipolar Affective Disorder-I, Bipolar Affective Disorder-II or Unipolar Depression according to DSM-5 criteria
- Being between the ages of 18-65
- At least primary school graduate
- No other medical illness to explain the current clinical picture
- No neurological or neurosurgical disease
Show all 9Show fewer
- Good general health and well-being
- No medication change in follow-up interviews for the last 2 weeks
- Euthymic or subthreshold symptoms in follow-up interviews (not meeting the criteria for a major mood episode)
Who cannot join
- Not meeting the DSM-5 criteria for Bipolar Affective Disorder-I, Bipolar Affective Disorder-II or Unipolar Depression
- The presence of another medical illness to explain the current clinical picture
- Diagnosis of a neurological or neurosurgical disease
- Poor general health
- Changes in medication therapy within 2 weeks prior to the examination in follow-up interviews
- Having a major mood episode in follow-up interviews
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University Cerrahpaşa - Cerrahpaşa Faculty of Medicine
Istanbul, 34098
About this study
Official title: The Relationship of Seasonality, Chronotype, Impulsivity and Suicidality in Patients With Bipolar Disorder and Unipolar Depression
The aim of the study is to examine the seasonal variation of suicidal ideation in patients with mood disorders and the trajectory of impulsivity and suicidal ideation in patients with higher seasonality. It also aims to identify seasonal and chronotype factors that contribute to the development of impulsivity and suicidal ideation.
Read the detailed description
This study aims to investigate the association between seasonality, chronotype, impulsivity, and suicidal thoughts in patients diagnosed with Bipolar Disorder-I and Unipolar Depression, who sought treatment at Istanbul University-Cerrahpasa, Faculty of Medicine, Department of Psychiatry.
Within the scope of this study, the seasonal variation of suicidal thoughts observed in patients with Bipolar Disorder and Unipolar Depression will be examined, along with the trajectory of impulsivity and suicidal thoughts in patients with higher seasonality. The study also aims to identify seasonal and chronotype factors that contribute to the development of impulsivity and suicidal thoughts. Ultimately, the research aims to facilitate early guidance and intervention for treatment purposes.
After providing information about the purpose and methodology of the study and obtaining informed consent, eligible participants will complete several assessment tools under the guidance of a clinician, including Socio-demographic and Clinical Characteristics Data Form, Seasonal Pattern Assessment Form, Morningness-Eveningness Questionnaire, Barratt Impulsivity Scale, and Beck Suicide Scale. The clinicians will also fill out the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) and Young Mania Rating Scale and/or Hypomania Checklist for patients with a diagnosis of Bipolar Disorder-I. Follow-up interviews will be conducted with each patient at 3, 6, 9, and 12 months, and the assessments will be repeated during these interviews.
Participants will be categorized based on the presence of seasonality and chronotypes. Correlation coefficients and appropriate statistical methods will be used to evaluate the relationship between seasonality, impulsivity, suicidality, and chronotype.
The study is designed to gain insights into the seasonal characteristics and psychopathology related to suicidal thoughts in patients with Bipolar Disorder and Unipolar Depression. The results will be used to identify risk factors and facilitate early interventions in psychiatric clinics.
- Keywords
- mood disorder, suicidality, impulsivity, seasonality, chronotype
- Medical subject headings
- Mood Disorders, Suicidal Ideation, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Bipolar Disorder in Remission | Not described | |
| Major Depression in Remission | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seasonal Pattern Assessment Form
Seasonal changes in sleep length, social activity, mood, energy level, weight, and appetite are each rated from 0 (no change) to 4 (extreme change). The six item scores are summed to produce one Global Seasonality Score ranging from 0 to 24 points. Higher scores indicate greater seasonal variation. The reported outcome is the total score in points, not separate measurements of sleep duration or body weight.
Measured: once at the first meeting
Morningness-Eveningness Questionnaire
The scores for the 19 questionnaire items are summed to obtain one total MEQ score, ranging from 16 to 86 points. Higher scores indicate greater morning preference, while lower scores indicate greater evening preference. The reported value is the total score in points.
Measured: once at the first meeting
Barratt Impulsiveness Scale (BIS-11)
Barratt Impulsiveness Scale, Version 11 (BIS-11) total score Description: The BIS-11 is a 30-item self-report questionnaire. Item scores are combined, with reverse scoring where required, to produce one total score ranging from 30 to 120 points. Higher scores indicate greater impulsiveness. The reported outcome is the total score in points.
Measured: At baseline and months 3, 6, 9
Beck Scale for Suicidal Ideations
The scale assesses the severity of suicidal ideation. The 19 scored items are rated from 0 to 2 and summed to produce one total score ranging from 0 to 38 points. Higher scores indicate more severe suicidal ideation. The reported outcome is the total score in points.
Measured: At baseline and months 3, 6, 9
Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
The 21 Hamilton depression item scores and 8 atypical symptom item scores are summed to produce one SIGH-SAD total score, ranging from 0 to 89 points. Higher scores indicate greater depressive symptom severity. The reported outcome is the total score in points.
Measured: At baseline and months 3, 6, 9
Body Mass Index
kg/m²
Measured: At baseline and months 3, 6, 9
Secondary outcomes (2)
Young Mania Rating Scale (YMRS) total score
The YMRS is an 11-item clinician-rated scale assessing manic symptom severity. Item scores are summed to produce one total score ranging from 0 to 60 points. Higher scores indicate more severe manic symptoms. The reported outcome is the total score in points.
Measured: At baseline and months 3, 6, 9
Hypomania Checklist (HCL-32)
The HCL-32 is a self-report checklist assessing a history of hypomanic symptoms. Each of the 32 symptom items is scored 0 (no) or 1 (yes). Positive responses are summed to produce one total score ranging from 0 to 32 points; higher scores indicate more reported hypomanic symptoms.
Measured: At baseline and months 3, 6, 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start22 Jun 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Bipolar Disorder in RemissionStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazife Gamze Usta Saglam, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857213
- Sponsor's protocol ID
- 00000
- Status last verified
- Sep 2026
- First submitted
- 30 Apr 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rakofsky J, Rapaport M. Mood Disorders. Continuum (Minneap Minn). 2018 Jun;24(3, BEHAVIORAL NEUROLOGY AND PSYCHIATRY):804-827. doi: 10.1212/CON.0000000000000604.
PubMed 29851879Luciano M, Sampogna G, Mancuso E, Simonetti A, De Fazio P, Di Nicola M, Di Lorenzo G, Pepe M, Sambataro F, Signorelli MS, Koukopoulos AE, Delle Chiaie R, Sani G, Fiorillo A. Trait-Related Impulsivity, Affective Temperaments and Mood Disorders: Results from a Real-World Multicentric Study. Brain Sci. 2022 Nov 15;12(11):1554. doi: 10.3390/brainsci12111554.
PubMed 36421878Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.
PubMed 3395203Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
PubMed 728692Lukasiewicz M, Gerard S, Besnard A, Falissard B, Perrin E, Sapin H, Tohen M, Reed C, Azorin JM; Emblem Study Group. Young Mania Rating Scale: how to interpret the numbers? Determination of a severity threshold and of the minimal clinically significant difference in the EMBLEM cohort. Int J Methods Psychiatr Res. 2013 Mar;22(1):46-58. doi: 10.1002/mpr.1379. Epub 2013 Mar 21.
PubMed 23526724Brambilla C, Gavinelli C, Delmonte D, Fulgosi MC, Barbini B, Colombo C, Smeraldi E. Seasonality and sleep: a clinical study on euthymic mood disorder patients. Depress Res Treat. 2012;2012:978962. doi: 10.1155/2012/978962. Epub 2011 Dec 8.
PubMed 22203895Watkins HB, Meyer TD. Is there an empirical link between impulsivity and suicidality in bipolar disorders? A review of the current literature and the potential psychological implications of the relationship. Bipolar Disord. 2013 Aug;15(5):542-58. doi: 10.1111/bdi.12090. Epub 2013 Jul 4.
PubMed 23822918Geoffroy PA, Bellivier F, Scott J, Etain B. Seasonality and bipolar disorder: a systematic review, from admission rates to seasonality of symptoms. J Affect Disord. 2014 Oct;168:210-23. doi: 10.1016/j.jad.2014.07.002. Epub 2014 Jul 10.
PubMed 25063960Rosenthal SJ, Josephs T, Kovtun O, McCarty R. Seasonal effects on bipolar disorder: A closer look. Neurosci Biobehav Rev. 2020 Aug;115:199-219. doi: 10.1016/j.neubiorev.2020.05.017. Epub 2020 May 30.
PubMed 32485266
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship of Seasonality, Chronotype, Impulsivity and Suicidality in Patients With Bipolar Disorder and Unipolar Depression
- ClinicalTrials.gov ID
- NCT07857213
- Acronym / sponsor ID
- 00000
- Keywords
- mood disorder, suicidality, impulsivity, seasonality, chronotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 22 Jun 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2025 (actual)
- First posted
- 5 Oct 2026 (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.
The aim of the study is to examine the seasonal variation of suicidal ideation in patients with mood disorders and the trajectory of impulsivity and suicidal ideation in patients with higher seasonality. It also aims to identify seasonal and chronotype factors that contribute to the development of impulsivity and suicidal ideation.
Detailed description
This study aims to investigate the association between seasonality, chronotype, impulsivity, and suicidal thoughts in patients diagnosed with Bipolar Disorder-I and Unipolar Depression, who sought treatment at Istanbul University-Cerrahpasa, Faculty of Medicine, Department of Psychiatry.
Within the scope of this study, the seasonal variation of suicidal thoughts observed in patients with Bipolar Disorder and Unipolar Depression will be examined, along with the trajectory of impulsivity and suicidal thoughts in patients with higher seasonality. The study also aims to identify seasonal and chronotype factors that contribute to the development of impulsivity and suicidal thoughts. Ultimately, the research aims to facilitate early guidance and intervention for treatment purposes.
After providing information about the purpose and methodology of the study and obtaining informed consent, eligible participants will complete several assessment tools under the guidance of a clinician, including Socio-demographic and Clinical Characteristics Data Form, Seasonal Pattern Assessment Form, Morningness-Eveningness Questionnaire, Barratt Impulsivity Scale, and Beck Suicide Scale. The clinicians will also fill out the Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD) and Young Mania Rating Scale and/or Hypomania Checklist for patients with a diagnosis of Bipolar Disorder-I. Follow-up interviews will be conducted with each patient at 3, 6, 9, and 12 months, and the assessments will be repeated during these interviews.
Participants will be categorized based on the presence of seasonality and chronotypes. Correlation coefficients and appropriate statistical methods will be used to evaluate the relationship between seasonality, impulsivity, suicidality, and chronotype.
The study is designed to gain insights into the seasonal characteristics and psychopathology related to suicidal thoughts in patients with Bipolar Disorder and Unipolar Depression. The results will be used to identify risk factors and facilitate early interventions in psychiatric clinics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar Disorder in Remission | – | – |
| Major Depression in Remission | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, patients who consecutively applied to the outpatient clinic of Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine, Department of Mental Health and Diseases between 01.09.2023 and 01.09.2024 and diagnosed with Bipolar Disorder or Unipolar Depression according to DSM-5 criteria will be included. It is planned to include at least 60 patients with each of these diagnoses in the study.
Key inclusion criteria (9 listed)
- To be willing and eager to participate in the study after reading and understanding the informed consent form
- Being diagnosed with Bipolar Affective Disorder-I, Bipolar Affective Disorder-II or Unipolar Depression according to DSM-5 criteria
- Being between the ages of 18-65
- At least primary school graduate
- No other medical illness to explain the current clinical picture
Key exclusion criteria (6 listed)
- Not meeting the DSM-5 criteria for Bipolar Affective Disorder-I, Bipolar Affective Disorder-II or Unipolar Depression
- The presence of another medical illness to explain the current clinical picture
- Diagnosis of a neurological or neurosurgical disease
- Poor general health
- Changes in medication therapy within 2 weeks prior to the examination in follow-up interviews
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Seasonal Pattern Assessment Form
Time frame: once at the first meeting
Seasonal changes in sleep length, social activity, mood, energy level, weight, and appetite are each rated from 0 (no change) to 4 (extreme change). The six item scores are summed to produce one Global Seasonality Score ranging from 0 to 24 points. Higher scores indicate greater seasonal variation. The reported outcome is the total score in points, not separate measurements of sleep duration or body weight.
Morningness-Eveningness Questionnaire
Time frame: once at the first meeting
The scores for the 19 questionnaire items are summed to obtain one total MEQ score, ranging from 16 to 86 points. Higher scores indicate greater morning preference, while lower scores indicate greater evening preference. The reported value is the total score in points.
Barratt Impulsiveness Scale (BIS-11)
Time frame: At baseline and months 3, 6, 9
Barratt Impulsiveness Scale, Version 11 (BIS-11) total score Description: The BIS-11 is a 30-item self-report questionnaire. Item scores are combined, with reverse scoring where required, to produce one total score ranging from 30 to 120 points. Higher scores indicate greater impulsiveness. The reported outcome is the total score in points.
Beck Scale for Suicidal Ideations
Time frame: At baseline and months 3, 6, 9
The scale assesses the severity of suicidal ideation. The 19 scored items are rated from 0 to 2 and summed to produce one total score ranging from 0 to 38 points. Higher scores indicate more severe suicidal ideation. The reported outcome is the total score in points.
Structured Interview Guide for the Hamilton Depression Rating Scale-Seasonal Affective Disorder Version (SIGH-SAD)
Time frame: At baseline and months 3, 6, 9
The 21 Hamilton depression item scores and 8 atypical symptom item scores are summed to produce one SIGH-SAD total score, ranging from 0 to 89 points. Higher scores indicate greater depressive symptom severity. The reported outcome is the total score in points.
Body Mass Index
Time frame: At baseline and months 3, 6, 9
kg/m²
2 secondary outcomes
Young Mania Rating Scale (YMRS) total score
Time frame: At baseline and months 3, 6, 9
Hypomania Checklist (HCL-32)
Time frame: At baseline and months 3, 6, 9
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 5 Oct 2026.
- Background: PubMed 29851879Rakofsky J, Rapaport M. Mood Disorders. Continuum (Minneap Minn). 2018 Jun;24(3, BEHAVIORAL NEUROLOGY AND PSYCHIATRY):804-827. doi: 10.1212/CON.0000000000000604.
- Background: PubMed 36421878Luciano M, Sampogna G, Mancuso E, Simonetti A, De Fazio P, Di Nicola M, Di Lorenzo G, Pepe M, Sambataro F, Signorelli MS, Koukopoulos AE, Delle Chiaie R, Sani G, Fiorillo A. Trait-Related Impulsivity, Affective Temperaments and Mood Disorders: Results from a Real-World Multicentric Study. Brain Sci. 2022 Nov 15;12(11):1554. doi: 10.3390/brainsci12111554.
- Background: PubMed 3395203Williams JB. A structured interview guide for the Hamilton Depression Rating Scale. Arch Gen Psychiatry. 1988 Aug;45(8):742-7. doi: 10.1001/archpsyc.1988.01800320058007.
- Background: PubMed 728692Young RC, Biggs JT, Ziegler VE, Meyer DA. A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry. 1978 Nov;133:429-35. doi: 10.1192/bjp.133.5.429.
- Background: PubMed 23526724Lukasiewicz M, Gerard S, Besnard A, Falissard B, Perrin E, Sapin H, Tohen M, Reed C, Azorin JM; Emblem Study Group. Young Mania Rating Scale: how to interpret the numbers? Determination of a severity threshold and of the minimal clinically significant difference in the EMBLEM cohort. Int J Methods Psychiatr Res. 2013 Mar;22(1):46-58. doi: 10.1002/mpr.1379. Epub 2013 Mar 21.
- Background: PubMed 22203895Brambilla C, Gavinelli C, Delmonte D, Fulgosi MC, Barbini B, Colombo C, Smeraldi E. Seasonality and sleep: a clinical study on euthymic mood disorder patients. Depress Res Treat. 2012;2012:978962. doi: 10.1155/2012/978962. Epub 2011 Dec 8.
- Background: PubMed 23822918Watkins HB, Meyer TD. Is there an empirical link between impulsivity and suicidality in bipolar disorders? A review of the current literature and the potential psychological implications of the relationship. Bipolar Disord. 2013 Aug;15(5):542-58. doi: 10.1111/bdi.12090. Epub 2013 Jul 4.
- Background: PubMed 25063960Geoffroy PA, Bellivier F, Scott J, Etain B. Seasonality and bipolar disorder: a systematic review, from admission rates to seasonality of symptoms. J Affect Disord. 2014 Oct;168:210-23. doi: 10.1016/j.jad.2014.07.002. Epub 2014 Jul 10.
- Background: PubMed 32485266Rosenthal SJ, Josephs T, Kovtun O, McCarty R. Seasonal effects on bipolar disorder: A closer look. Neurosci Biobehav Rev. 2020 Aug;115:199-219. doi: 10.1016/j.neubiorev.2020.05.017. Epub 2020 May 30.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder in Remission and Major Depression in Remission, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 9 inclusion and 6 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Seasonal Pattern Assessment Form (time frame: once at the first meeting). The study lists 6 primary outcomes in all. 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 NCT07857213, which also lists 9 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 5 Oct 2026.