Page last updated: 2024-10-21

urea and Depression, Involutional

urea has been researched along with Depression, Involutional in 11 studies

pseudourea: clinical use; structure
isourea : A carboximidic acid that is the imidic acid tautomer of urea, H2NC(=NH)OH, and its hydrocarbyl derivatives.

Depression, Involutional: Form of depression in those MIDDLE AGE with feelings of ANXIETY.

Research Excerpts

ExcerptRelevanceReference
"In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, a randomized, double-blind, placebo-controlled study in patients with major depression and an inadequate response to previous therapy."9.34Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study. ( Dirks, B; Fava, M; Freeman, MP; Jha, MK; Liu, K; Papakostas, GI; Shelton, RC; Stankovic, S; Thase, ME; Trivedi, MH, 2020)
"Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD."9.34Effect of adjunctive pimavanserin on suicidal ideation in patients with major depression: Analysis of the CLARITY study. ( Dirks, B; Fava, M; Freeman, MP; Jha, MK; Liu, K; Papakostas, GI; Shelton, RC; Stankovic, S; Thase, ME; Trivedi, MH, 2020)
"In a post hoc analysis, the effect of pimavanserin on anxious depression was determined from CLARITY, a randomized, double-blind, placebo-controlled study in patients with major depression and an inadequate response to previous therapy."5.34Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study. ( Dirks, B; Fava, M; Freeman, MP; Jha, MK; Liu, K; Papakostas, GI; Shelton, RC; Stankovic, S; Thase, ME; Trivedi, MH, 2020)
"Adjunctive pimavanserin was not associated with an increase in suicidal ideation in patients with MDD."5.34Effect of adjunctive pimavanserin on suicidal ideation in patients with major depression: Analysis of the CLARITY study. ( Dirks, B; Fava, M; Freeman, MP; Jha, MK; Liu, K; Papakostas, GI; Shelton, RC; Stankovic, S; Thase, ME; Trivedi, MH, 2020)
"Pimavanserin is a 5-hydroxytryptamine-2A antagonist and inverse receptor agonist."2.90A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY). ( Dirks, B; Fava, M; Freeman, MP; Liu, K; Papakostas, GI; Shelton, RC; Stankovic, S; Thase, ME; Trivedi, MH, 2019)
"But ventricular tachycardia is rare."1.34Incessant non-sustained ventricular tachycardia after stimulus of electroconvulsive therapy with atropine premedication? ( Kim, C; Kitamura, A; Nakanishi, K; Sakamoto, A; Sato, C; Yokozuka, M, 2007)
"Fifteen participants diagnosed with major depressive disorder and 15 controls were scanned during a lexical decision task involving neutral, happy, sad, and threat-related words."1.32Brain activation to emotional words in depressed vs healthy subjects. ( Canli, T; Gabrieli, JD; Gotlib, IH; Sivers, H; Thomason, ME; Whitfield-Gabrieli, S, 2004)

Research

Studies (11)

TimeframeStudies, this research(%)All Research%
pre-19901 (9.09)18.7374
1990's0 (0.00)18.2507
2000's3 (27.27)29.6817
2010's2 (18.18)24.3611
2020's5 (45.45)2.80

Authors

AuthorsStudies
Fava, M5
Dirks, B5
Freeman, MP5
Papakostas, GI5
Shelton, RC5
Thase, ME5
Trivedi, MH5
Liu, K5
Stankovic, S5
Jha, MK5
Soogrim, V1
Ruberto, VL1
Murrough, J1
Rotroff, DM1
Corum, DG1
Motsinger-Reif, A1
Fiehn, O1
Bottrel, N1
Drevets, WC1
Singh, J1
Salvadore, G1
Kaddurah-Daouk, R1
Canli, T2
Sivers, H2
Thomason, ME1
Whitfield-Gabrieli, S2
Gabrieli, JD2
Gotlib, IH2
Goldin, P1
Minor, KL1
Kim, C1
Yokozuka, M1
Sato, C1
Nakanishi, K1
Kitamura, A1
Sakamoto, A1
Misurec, J1
Morávek, Z1
Náhunek, K1

Clinical Trials (1)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder[NCT03018340]Phase 2207 participants (Actual)Interventional2016-12-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

CGI-I Score at Week 5

The Clinical Global Impression- Improvement scale is a 1-item scale, used to rate the global improvement of the patient since beginning of the study from 0 (not assessed) to 7 (very much worse). A higher CGI-I score denotes less improvement in depression. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

Interventionscore on a scale (Least Squares Mean)
Pimavanserin 34 mg + SSRI/SNRI, Stage 12.2
Placebo + SSRI/SNRI, Stage 12.8
Pimavanserin 34 mg + SSRI/SNRI, Stage 23.0
Placebo + SSRI/SNRI, Stage 23.1

Change From Baseline to Week 5 in BIS-11 Score

The Barratt Impulsiveness Scale-11 is a questionnaire for assessment of the personality/behavioral construct of impulsiveness. It is composed of 30 items describing common impulsive or non-impulsive (for reverse scored items) behaviors and preferences. Items are scored on a 4-point scale from Rarely/Never (1) to Almost Always/Always (4). Items are summed up to calculate the total score. The BIS-11 total score ranges from 30 to 120. Higher scores denotes more impulsiveness. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 172.5-4.2
Pimavanserin 34 mg + SSRI/SNRI, Stage 265.9-1.4
Placebo + SSRI/SNRI, Stage 170.0-2.8
Placebo + SSRI/SNRI, Stage 270.31.7

Change From Baseline to Week 5 in CGI-S Total Score

The Clinical Global Impression-Severity Scale is a 1-item scale, used to rate the severity of the disorder from 0 (not assessed) to 7 (among the most extremely ill patients). A higher CGI-I score denotes more severe depression. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 14.6-2.0
Pimavanserin 34 mg + SSRI/SNRI, Stage 24.1-0.5
Placebo + SSRI/SNRI, Stage 14.4-1.1
Placebo + SSRI/SNRI, Stage 24.1-0.5

Change From Baseline to Week 5 in DAI-10 Score

"The Drug Attitude Inventory-10 is a 6-item patient-facing questionnaire to evaluate a patient's perceptions and experiences of treatment. It contains 6 items that a patient who is fully adherent to prescribed medication would answer as True, and 4 items that a patient who is fully adherent would rate as False. Scores are allocated to each answer and the total score is calculated as the sum. A correct answer is scored +1 and an incorrect answer is scored -1. The total score ranges from -10 to 10 and is the sum of pluses and minuses. A positive total score indicates a positive subjective response (adherent) and a negative total score indicates a negative subjective response (nonadherent). Higher scores denoted better adherence." (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 14.21.4
Pimavanserin 34 mg + SSRI/SNRI, Stage 25.10.6
Placebo + SSRI/SNRI, Stage 14.40.5
Placebo + SSRI/SNRI, Stage 24.80.3

Change From Baseline to Week 5 in KSS Score

"The Karolinska Sleepiness Scale is a patient-facing 1-item scale that measures the patient's drowsiness. Scoring is based on a 9-point verbally anchored scale ranging from extremely alert (1) to very sleepy, great effort to keep awake, fighting sleep (9). Higher scores denote more drowsiness." (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 16.7-1.9
Pimavanserin 34 mg + SSRI/SNRI, Stage 26.7-0.5
Placebo + SSRI/SNRI, Stage 16.6-0.4
Placebo + SSRI/SNRI, Stage 26.1-0.2

Change From Baseline to Week 5 in MGH-SFI Score

"The Massachusetts General Hospital Sexual Functioning Index is a patient-facing questionnaire that quantifies sexual dysfunction into 5 functional domains (interest in sex, sexual arousal, ability to achieve orgasm, ability to maintain erection [males only], and sexual satisfaction). Patients rate each item using a 6-point scale ranging from 1 (good function) to 6 (poor function). The MGH-SFI score is calculated as the arithmetic mean of the item scores for the 5 domains. The mean MGH-SFI score ranges from a minimum value of 1 to a maximum value of 6. Higher scores denotes worse sexual dysfunction." (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 14.642-0.830
Pimavanserin 34 mg + SSRI/SNRI, Stage 24.678-0.472
Placebo + SSRI/SNRI, Stage 14.457-0.155
Placebo + SSRI/SNRI, Stage 24.264-0.183

Change From Baseline to Week 5 in SF-12 Score

The 12-Item Short Form Health Survey is a patient-reported outcome measure that addresses 8 domains of physical functioning, role - physical, bodily pain, general health perceptions, vitality, social functioning, role - emotional, and mental health. Composite scores were obtained representing physical health and mental health composite summaries, Physical Component Summary (PCS) and Mental Component Summary (MCS), respectively. An algorithm was used to generate PCS and MCS for comparison to normative data. In normative data, the mean score was set to 50; thus, scores >50 indicate better physical or mental health than the mean and scores <50 indicate worse health. A higher score is indicative of a better health state. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
PCS baseline (BL)PCS change from BL to Week 5MCS baseline (BL)MCS change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 149.587-0.98123.11316.146
Pimavanserin 34 mg + SSRI/SNRI, Stage 246.945-0.54627.5573.566
Placebo + SSRI/SNRI, Stage 148.783-0.72624.0047.989
Placebo + SSRI/SNRI, Stage 248.9941.81128.5240.578

Change From Baseline to Week 5 in SIS Score

The Sheehan Irritability Scale is a 7-item patient-reported outcome measure to measure the frequency, severity, and impairment associated with irritability in psychiatric patients. It includes items on: irritability, frustration, edginess/ impatience/ overreaction, moodiness, anger with self, anger with others, and temper. Items are answered on an 11-point rating scale where higher scores indicated greater severity (0=not at all, 10=extremely). Item responses are summed into a total score (range=0-70). Higher scores mean higher irritability. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 138.9-19.4
Pimavanserin 34 mg + SSRI/SNRI, Stage 235.2-4.8
Placebo + SSRI/SNRI, Stage 138.8-10.8
Placebo + SSRI/SNRI, Stage 236.6-6.6

Change From Baseline to Week 5 in the HAMD-17 Total Score

The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. The HAMD-17 consists of 8 items with a score on a 3 point scale and 9 items with a score on a 5 point scale. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4, depending on the item. Items are summed up to calculate the HAMD-17 total score. The total score ranges from 0 to 52. A higher total score indicates more severe depression. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Baseline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 122.9-11.9
Pimavanserin 34 mg + SSRI/SNRI, Stage 220.3-2.8
Placebo + SSRI/SNRI, Stage 122.0-7.1
Placebo + SSRI/SNRI, Stage 220.4-3.2

Change From Baseline to Week 5 in the SDS Total Score

The Sheehan Disability Scale is a 3-item patient-facing questionnaire used to evaluate impairments in the domains of work, social life/leisure, and family life/home responsibility. All items are rated on an 11-point scale from 0 (no impairment) to 10 (most severe). The total SDS score ranges from 0 to 10. It is calculated as the arithmetic mean of the scores for all 3 items. A higher score indicates greater disability. (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
Interventionscore on a scale (Mean)
Basline (BL)Change from BL to Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 16.365-3.229
Pimavanserin 34 mg + SSRI/SNRI, Stage 25.753-0.890
Placebo + SSRI/SNRI, Stage 16.519-2.026
Placebo + SSRI/SNRI, Stage 25.747-0.507

Treatment Response and Remission Rates at the End of 5-week Treatment Period

"The Hamilton Rating Scale for Depression (HAMD-17) is a 17-item scale to assess depression. Each item is rated from least (0) to most frequent or most severe, as applicable, with highest scores of 2 to 4 depending on the item. Items are summed up to calculate the HAMD-17 total score. A higher total score indicates more severe depression.~Treatment response was defined as a reduction from Baseline in HAMD-17 total score of >=50%.~Remission was defined as a HAMD-17 total score <=7." (NCT03018340)
Timeframe: Baseline, 5 weeks and 10 weeks during Stage 1 and Stage 2, respectively

,,,
InterventionParticipants (Count of Participants)
Treatment responders Week 5Remission rate Week 5
Pimavanserin 34 mg + SSRI/SNRI, Stage 12712
Pimavanserin 34 mg + SSRI/SNRI, Stage 221
Placebo + SSRI/SNRI, Stage 13817
Placebo + SSRI/SNRI, Stage 221

Reviews

1 review available for urea and Depression, Involutional

ArticleYear
Spotlight on Pimavanserin Tartrate and Its Therapeutic Potential in the Treatment of Major Depressive Disorder: The Evidence to Date.
    Drug design, development and therapy, 2021, Volume: 15

    Topics: Antipsychotic Agents; Depressive Disorder, Major; Humans; Piperidines; Receptors, Serotonin; Urea

2021

Trials

5 trials available for urea and Depression, Involutional

ArticleYear
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study of Adjunctive Pimavanserin in Patients With Major Depressive Disorder and an Inadequate Response to Therapy (CLARITY).
    The Journal of clinical psychiatry, 2019, 09-24, Volume: 80, Issue:6

    Topics: Adult; Aged; Depressive Disorder, Major; Double-Blind Method; Drug Therapy, Combination; Female; Hum

2019
Effect of pimavanserin on anxious depression in patients with major depression and an inadequate response to previous therapy: secondary analysis of the clarity study.
    International clinical psychopharmacology, 2020, Volume: 35, Issue:6

    Topics: Adult; Antidepressive Agents; Antipsychotic Agents; Anxiety; Depression; Depressive Disorder, Major;

2020
Effect of adjunctive pimavanserin on suicidal ideation in patients with major depression: Analysis of the CLARITY study.
    Journal of affective disorders, 2020, 12-01, Volume: 277

    Topics: Adult; Depression; Depressive Disorder, Major; Double-Blind Method; Humans; Piperidines; Suicidal Id

2020
Effect of Adjunctive Pimavanserin on Sleep/Wakefulness in Patients With Major Depressive Disorder: Secondary Analysis From CLARITY.
    The Journal of clinical psychiatry, 2020, 12-01, Volume: 82, Issue:1

    Topics: Adolescent; Adult; Aged; Antidepressive Agents; Depressive Disorder, Major; Double-Blind Method; Dru

2020
Lisurid (Lysenyl Spofa) in the treatment of organic psychosyndrome in involution.
    Activitas nervosa superior, 1978, Volume: 20, Issue:1

    Topics: Clinical Trials as Topic; Depressive Disorder, Major; Double-Blind Method; Ergolines; Humans; Urea

1978

Other Studies

5 other studies available for urea and Depression, Involutional

ArticleYear
Improvement of sexual functioning during treatment of MDD with adjunctive pimavanserin: A secondary analysis.
    Depression and anxiety, 2020, Volume: 37, Issue:5

    Topics: Adult; Antidepressive Agents; Antipsychotic Agents; Depressive Disorder, Major; Double-Blind Method;

2020
Metabolomic signatures of drug response phenotypes for ketamine and esketamine in subjects with refractory major depressive disorder: new mechanistic insights for rapid acting antidepressants.
    Translational psychiatry, 2016, 09-20, Volume: 6, Issue:9

    Topics: Adult; Arginine; Citrulline; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; E

2016
Brain activation to emotional words in depressed vs healthy subjects.
    Neuroreport, 2004, Dec-03, Volume: 15, Issue:17

    Topics: Adult; Analysis of Variance; Brain; Brain Mapping; Carbamide Peroxide; Case-Control Studies; Cogniti

2004
Subgenual anterior cingulate activation to valenced emotional stimuli in major depression.
    Neuroreport, 2005, Nov-07, Volume: 16, Issue:16

    Topics: Adult; Brain Mapping; Carbamide Peroxide; Depressive Disorder, Major; Drug Combinations; Emotions; F

2005
Incessant non-sustained ventricular tachycardia after stimulus of electroconvulsive therapy with atropine premedication?
    Psychiatry and clinical neurosciences, 2007, Volume: 61, Issue:5

    Topics: Adrenergic beta-Antagonists; Anti-Arrhythmia Agents; Atropine; Depressive Disorder, Major; Electroca

2007