A Phase 1/2 interventional study of Hypomanic Personality Scale - 6 in Bipolar Disorder (BD), sponsored by Babes-Bolyai University. Recruiting at 1 site in Romania. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-10.
Sponsored by Babes-Bolyai University · Phase 1/2, Interventional, and Screening
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.
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 50 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Babes-Bolyai University is the lead sponsor of 51 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
Meant for piloting scale, EFA
Diagnostic Test: Hypomanic Personality Scale - 6
Formally clinically evaluated sample, used for CFA
Diagnostic Test: Hypomanic Personality Scale - 6
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.
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.
Time frame: Baseline and one month later for re-test measures (in order to account for test-retest reliability)
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).
Time frame: Baseline
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).
Time frame: One month after Baseline
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.
Time frame: One month after Baseline.
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.
Time frame: One month after Baseline
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.
Time frame: One month after Baseline
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).
Time frame: One month after Baseline.
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.
Time frame: Baseline
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).
Time frame: Baseline
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.
Time frame: Baseline
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.
Time frame: Baseline
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).
Time frame: Baseline
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.
Time frame: Baseline
Plan to share: Undecided — Ethics regarding the limited clinical sample.
Started Sep 2025 (actual). Primary completion is estimated for May 2026, 8 months after the start.
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