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Bipolar Disorder (BD)Phase 1/2NCT07399626

Adaptation and Validation of the Hypomanic Personality Scale (HPS-6) to Romanian

A Phase 1/2 study testing Hypomanic Personality Scale - 6 in people with Bipolar Disorder (BD), run by Babes-Bolyai University at 1 site in Romania.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The HPS-6 (Hypomanic Personality Scale, 6 item version) could prove to be a valuable candidate for screening measures of high risk individuals. In the following study, we aim to validate and adapt the HPS-6 for the Romanian population. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Bipolar Disorder (BD)
What is being tested?
Hypomanic Personality Scale - 6
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteRomania
Study dates
22 Sep 2025to Jul 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 18-50 years of age
  • Not at high risk of suicide (current)
  • Not high SUDs / AUDs (current)
  • Native Romanian speaker
  • Cognitive abilities intact (reading comprehension of items)

Who cannot join

  • High risk of suicide (current)
  • High SUDs / AUDs (current)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Renata Gheorghiu, PhD Student contact

Romania: 0731 739 485

renata.gheorghiu@ubbcluj.ro

Romania1 site, 1 recruiting

  • Babeș-Bolyai University

    Cluj-Napoca, 400084

    Renata Gheorghiu, PhD Student, 0731739485, renata.gheorghiu@ubbcluj.ro

    Recruiting

Other trials in Romania

About this study

Official title: Adaptation and Validation of the Hypomanic Personality Scale (HPS-6) to Romanian.

The HPS-6 (Hypomanic Personality Scale, 6 item version) could prove to be a valuable candidate for screening measures of high risk individuals. In the following study, we aim to validate and adapt the HPS-6 for the Romanian population.

Read the detailed description

Bipolar disorder (BD) is a chronic, debilitating disorder, affecting approximately 2.4% of the global population. Inaccurate diagnosis leads to inappropriate management of the disorder as well as unsuitable medication prescription. On average, it can take a BD individual 5 to 10 years to receive an accurate diagnosis and receive competent treatment. Across the European Union (EU) Romania has the lowest prevalence of psychiatric disorders, 14.3%. Unfortunately, these positive estimates are related to the severe stigma linked to poor mental health in the Romanian population. Although the average length of a psychiatric stay in the EU spans across 24.3 days, Romania's average is 17.7. Poor infrastructure and lack of personnel in the Romanian healthcare system might be partially responsible. Therefore, brief, validated screening measures for complex diagnoses are necessary.

Being tested
Hypomanic Personality Scale - 6
Keywords
bipolar disorder, manic-depression, cyclothymia
Medical subject headings
Bipolar Disorder, Cyclothymic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hypomanic Personality Scale - 6Diagnostic test

    A brief instrument, such as the HPS-6, with high specificity can help navigate specialists towards a correct diagnosis or recognize risk patterns in Bipolar Spectrum Individuals.

Study groups in NCT07399626
Study groupRoleWhat they receive
Community PilotingOtherMeant for piloting scale, EFA
Receives: Diagnostic Test: Hypomanic Personality Scale - 6
Clinical / Risk GroupOtherFormally clinically evaluated sample, used for CFA
Receives: Diagnostic Test: Hypomanic Personality Scale - 6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hypomanic Personality Scale - 6 (HPS-6)

    The main instrument of the study, the HPS-6 is used to assess bipolar spectrum disorder risk due to and individual's phenotype. The scale contains 6 items and has a binary rating scale ("TRUE" / "FALSE"). The original authors used a cut-off of 3 or higher to represent possible risk for the disorder. Minimum score possible is 0, while the highest is 6.

    Measured: Baseline and one month later for re-test measures (in order to account for test-retest reliability)

  2. Mood Disorder Questionnaire (MDQ)

    In order to check for convergent validity, the Mood Disorder Questionnaire was administered as well. The instrument screens for a history of manic or hypomanic symptoms. It contains 13 yes or no items created based on the DSM-IV, followed by a 4-point Likert question on the level of impairment; "no problem" to "serious problem" and a 15th item asking is symptoms happened simultaneously. Studies recommend a cut-off of >5 for high risk bipolar populations. The original cut-off of the scale is >7, but it has been criticized for high specificity. The total score is 13 (MIN: 0, MAX: 13).

    Measured: Baseline

  3. Behavioral Inhibition System / Behavioral Activation System scales (BISBAS)

    The BIS / BAS scales assess two motivational systems, the Behavioral Inhibition System and the Behavioral Activation System. The scale contains 20 items in total. The BAS system, or the approach tendency, is hypothesized to facilitate goal-motivated behavior when presented with incentives, generating an increase in behaviors oriented towards goals, while the BIS motivational system activates inhibition tendencies. Higher scores indicate sensitivity to threats, non-reward (BIS) or the sensitivity towards reward and goal striving (BAS). Total possible score for the BIS subscale is 28 (MIN: 7, MAX: 28), while for the BAS subscale the total possible is 91 (MIN: 13, MAX: 91).

    Measured: One month after Baseline

  4. Positive and Negative Affect Schedule (PANAS)

    The Positive and Negative Affect Schedule is a 20-item self-report measure assessing positive and negative affect. Participants rate each item on a 5-point Likert scale ranging from 1 ("very slightly or not at all") to 5 ("extremely"). Each subscale has a possible score range of 10 to 50. Higher PA scores reflect greater energy and concentration, whereas higher NA scores indicate greater levels of distress.

    Measured: One month after Baseline.

  5. Negative Urgency, Premeditation, Perseverance, Sensations Seeking, and Positive Urgency - Impulsive Behavior Scale (UPPS-P)

    The UPPS-P Impulsive Behavior Scale assesses positive and negative emotional urgency along with multiple dimensions of impulsivity. The full instrument includes 59 items across five subscales: Negative Urgency, Positive Urgency, (Lack of) Premeditation, (Lack of) Perseverance, and Sensation Seeking. A scoping review has shown that individuals with bipolar disorder exhibit elevated impulsivity during both positive and negative emotional states, with particularly large effect sizes observed for positive urgency. Because the HPS-6 focuses on positively valenced experiences, only the Positive Urgency subscale was administered in this study. Scores on this subscale range from 14 to 56, with higher average scores indicating greater impulsive tendencies.

    Measured: One month after Baseline

  6. Affective Lability Scale - Short Form (ALS-18)

    The ALS-18 is an 18-item measure designed to assess shifts between neutral states and intense affect, emphasizing emotional variability rather than current symptom severity. It comprises three main subscales: Anxiety/Depression Shift (5 items), Depression/Elation Shift (8 items), and Anger (5 items). Items are rated on a 4-point Likert scale ranging from 0 ("very uncharacteristic of me") to 3 ("very characteristic of me"). The total raw score ranges from 0 to 54, with higher scores indicating greater affective lability, reflected in more frequent and intense mood shifts.

    Measured: One month after Baseline

  7. Positive Overgeneralization (POG)

    The Positive Overgeneralization Scale (POG) measures the "tendency to generalize good experiences in one domain to broader aspects of life". it contains 3 subscales (lateral generalization, upward generalization and social generalization), comprising altogether 16 items. Lower scores represent a higher predisposition towards that type of positive overgeneralization (Subscale 1 - Lateral generalization: MAX - 30, MIN: 6 , Subscale 2 - Upward generalization: MAX - 25, MIN - 5, Subscale 3 - Social generalization: MAX - 25, MIN - 5).

    Measured: One month after Baseline.

  8. Altman Self-Rating Mania Scale (ASRM)

    The instrument evaluates manic symptom presence and their severity using 5 items, rated on a 4-point Likert scale. Total scores span from 0 to 20, and scores of 6 or above suggest a possible presence of hypomanic or manic symptoms.

    Measured: Baseline

  9. Food Neophobia Scale (FNS)

    The scale measures one's reluctance to try new or unfamiliar foods. The FNS consists of 10 items rated on a 7-point Likert scale. It has been widely used internationally across diverse fields. Five items assess neophobic behavior, defined as fear of new or unfamiliar experiences, while the remaining five assess neophilic behavior, reflecting interest in and enthusiasm for novelty. Higher FNS scores indicate greater levels of neophobia (MIN: 10, MAX: 70).

    Measured: Baseline

  10. Patient Health Questionnaire-9 (PHQ-9)

    The Patient Health Questionnaire-9 is a diagnostic tool for depression based on DSM-IV criteria. It includes nine items rated on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"). Using the algorithm method, a diagnosis is indicated when five or more symptoms have been present for more than half of the days over the past two weeks. Total scores range from 0 to 21. Alternatively, the summed-item approach involves adding the item scores, with a commonly used cutoff of 10 points to indicate major depressive disorder.

    Measured: Baseline

  11. Importance of Olfaction (IOS)

    The Importance of Olfaction scale assesses core olfactory functions. It consists of 18 items rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"). The scale was designed for use across different cultures and age groups. It includes five subscales reflecting various domains of the importance of smell (e.g., mating and bonding). Total scores range from 18 to 90, with higher scores indicating a greater personal importance attributed to the sense of smell.

    Measured: Baseline

Secondary outcomes (2)

  1. Psychiatric Diagnostic Screening Questionnaire (PDSQ)

    We used 12 of the 13 subscales of the Psychiatric Diagnostic Screening Questionnaire (PDSQ) to screen for additional psychiatric conditions. The depression subscale was excluded because depressive symptoms were assessed separately with the PHQ-9, and participants also underwent a formal clinical evaluation in which depression was examined in greater detail. The PDSQ is a self-administered screening instrument for common mental health disorders. The Romanian version includes 125 items, with higher scores indicating a greater risk for the respective disorder. Using these subscales, we assessed risk for PTSD, bulimia nervosa, obsessive-compulsive disorder, panic disorder, psychosis, agoraphobia, social phobia, alcohol use disorder, medication abuse, generalized anxiety disorder, and hypochondria (health anxiety).

    Measured: Baseline

  2. Suicide Behavior Questionnaire-Revised (SBQ-R)

    The SBQ-R is a brief, four-item measure that assesses multiple dimensions of suicidality and provides an overall suicide risk score. Scores of 7 or higher indicate elevated risk in non-clinical samples, whereas a cutoff of 8 or higher is used for clinical samples. Participants were not excluded based on suicide risk, as doing so could introduce bias into the research. Total scores range from 3 to 18.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2026
  2. Study start22 Sep 2025
  3. Primary completionMay 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Sequential
Model description
The first wave of participants recruits individuals from the community and is meant to pilot the instrument, check its stability and be utilized for exploratory factor analysis. The second wave will be used to test the instrument across DSM-5 validated diagnoses (via SCID-5-CV semi-structured clinical interview) and for confirmatory factor analysis.
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07399626
Sponsor's protocol ID
1068/10.12.2025
Status last verified
Feb 2026
First submitted
27 Jan 2026
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: Ethics regarding the limited clinical sample.

Publications

  • Wang HR, Woo YS, Ahn HS, Ahn IM, Kim HJ, Bahk WM. THE VALIDITY OF THE MOOD DISORDER QUESTIONNAIRE FOR SCREENING BIPOLAR DISORDER: A META-ANALYSIS. Depress Anxiety. 2015 Jul;32(7):527-38. doi: 10.1002/da.22374. Epub 2015 May 22.

    PubMed 26010478

  • Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (1999). Patient Health Questionnaire-9 (PHQ-9). APA PsycTests, 10. https://doi.org/10.1037/t06165-000

  • Manea L, Gilbody S, McMillan D. A diagnostic meta-analysis of the Patient Health Questionnaire-9 (PHQ-9) algorithm scoring method as a screen for depression. Gen Hosp Psychiatry. 2015 Jan-Feb;37(1):67-75. doi: 10.1016/j.genhosppsych.2014.09.009. Epub 2014 Sep 23.

    PubMed 25439733

  • Levis B, Benedetti A, Thombs BD; DEPRESsion Screening Data (DEPRESSD) Collaboration. Accuracy of Patient Health Questionnaire-9 (PHQ-9) for screening to detect major depression: individual participant data meta-analysis. BMJ. 2019 Apr 9;365:l1476. doi: 10.1136/bmj.l1476.

    PubMed 30967483

  • Pliner P, Hobden K. Development of a scale to measure the trait of food neophobia in humans. Appetite. 1992 Oct;19(2):105-20. doi: 10.1016/0195-6663(92)90014-w.

    PubMed 1489209

  • Rabadán, A., & Bernabéu, R. (2021). A systematic review of studies using the Food Neophobia Scale: Conclusions from thirty years of studies. Food Quality and Preference, 93, 104241. https://doi.org/10.1016/j.foodqual.2021.104241

  • Sorokowski, P., Sorokowska, A., Misiak, M., & Roberts, S. C. (2023). Developmental changes in food and non-food odor importance-Data from Scotland and Pakistan. Food Quality and Preference, 111, 104963.

  • Meyer, T. D., & Baur, M. (2009). Positive and negative affect in individuals at high and low risk for bipolar disorders. Journal of Individual Differences, 30(3), 169-175.

  • Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

    PubMed 3397865

  • Teh WL, Si SY, Liu J, Subramaniam M, Ho R. The clinical significance of emotional urgency in bipolar disorder: a scoping review. BMC Psychol. 2024 May 15;12(1):273. doi: 10.1186/s40359-024-01700-1.

    PubMed 38750587

  • Eisner LR, Johnson SL, Carver CS. Cognitive responses to failure and success relate uniquely to bipolar depression versus mania. J Abnorm Psychol. 2008 Feb;117(1):154-63. doi: 10.1037/0021-843X.117.1.154.

    PubMed 18266493

  • Johnson, S. L., Turner, R. J., & Iwata, N. (2003). BIS/BAS levels and psychiatric disorder: An epidemiological study. Journal of psychopathology and behavioral assessment, 25(1), 25-36.

  • Carver, C. S., & White, T. L. (1994). Behavioral inhibition, behavioral activation, and affective responses to impending reward and punishment: the BIS/BAS scales. Journal of personality and social psychology, 67(2), 319.

  • Osman A, Bagge CL, Gutierrez PM, Konick LC, Kopper BA, Barrios FX. The Suicidal Behaviors Questionnaire-Revised (SBQ-R): validation with clinical and nonclinical samples. Assessment. 2001 Dec;8(4):443-54. doi: 10.1177/107319110100800409.

    PubMed 11785588

  • Kwapil TR, Miller MB, Zinser MC, Chapman LJ, Chapman J, Eckblad M. A longitudinal study of high scorers on the hypomanic personality scale. J Abnorm Psychol. 2000 May;109(2):222-6.

    PubMed 10895560

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Hypomanic Personality Scale - 6 in people with Bipolar Disorder (BD), run by Babes-Bolyai University at 1 site in Romania.

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 5 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: looking for participants now, as of the sponsor's last update on 10 Feb 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 Romania. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Renata Gheorghiu, PhD Student (Romania: 0731 739 485, renata.gheorghiu@ubbcluj.ro), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hypomanic Personality Scale - 6 (HPS-6) (time frame: Baseline and one month later for re-test measures (in order to account for test-retest reliability)). The study lists 11 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 NCT07399626, which also lists 23 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 10 Feb 2026.

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