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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05930912
Other study ID # ASD-Psy-000
Secondary ID ASD-000000
Status Active, not recruiting
Phase
First received
Last updated
Start date June 1, 2023
Est. completion date December 1, 2023

Study information

Verified date June 2023
Source Pachankis, Yang I., M.D.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Autism Spectrum Disorder (ASD) is often accompanied by a variety of other symptoms, such as bipolar disorder, Attention Deficit Hyperactivity Disorder (ADHD), Social Anxiety Disorder (SAD), Avoidant Personality Disorder (AvPD), Obsessive Compulsive Disorder (OCD), etc. The behavioral and social complications often marginalize the population, impact on life satisfaction, undermined societal values that impact on economic and financial fairness, and so forth. Furthermore, persons with ASD are neurodiverse from standardized pharmacological and clinical cares, and are interpreted disadvantaged in the context of neurotypical treatments. The research protocol aims to differentiate the neuropharmacological implications of ASD from its behavioral and social implications. Such a differentiation is beneficial to the quality of care for neurodiverse population, both in terms of precision treatment in medical settings, and in terms of psychotherapeutic treatment efficacy in the interpretation of behavioral and social traits. The study protocol continues from the adverse event of the participant in NCT05711810 trial, after the positive immunological results in the NCT05839236 trial. The intervention medicine continues from Sertraline adjusted on the choice of Selective Serotonin Reuptake Inhibitor (SSRI) in the previous two trials for complex post-traumatic stress disorder (CPTSD) of the participant, and its combined used with Duloxetine in the choice of Selective Norephedrine Reuptake Inhibitor (SNRI) for norephedrine regulations. The hypothesized target is on the discrete psychiatric intervention centered approach to ASD treatment care. In the PRC where the study is being carried out, amphetamine class medicines are strictly prohibited and defined as illegal substances, regardless of their only proven effect for ASD patient care. Contributed by the sociostructural elements and necessities, black market amphetamine and ketamine have not only emerged in the regime for decades, but also have become a lucrative business. Their recreational uses are also sometimes accompanied by real necessities and needs; black markets cater to the needs but guidance on the usages is based on word-of-mouth stories without professional medical assistances. There is one case the Principal Investigator (PI) collected, that one person, possibly under depression contributed by PTSD, took relatively high dosage of amphetamine and went into a state of psychosis with overwhelming persecution mania. The study protocol, Psychiatric Orders in Psychoanalytic Treatment of ASD, is therefore designed for an evidence-based approach in treating complex psychiatric disorders with psychoanalytic guidance.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1
Est. completion date December 1, 2023
Est. primary completion date September 1, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Persons with ASD. Exclusion Criteria: - Severe ASD cases with central nerve system complications.

Study Design


Related Conditions & MeSH terms

  • ADHD - Combined Type
  • Adjustment Disorders
  • Agoraphobia
  • Agoraphobia With Panic Attacks
  • Anxiety Disorders
  • Autism Spectrum Disorder
  • Autism Spectrum Disorder High-Functioning
  • Avoidant Personality Disorder
  • Borderline Personality Disorder
  • Depression
  • Depression and Suicide
  • Depression Anxiety Disorder
  • Depression, Anxiety
  • Depression, Reactive
  • Depression, Unipolar
  • Depression; Psychoneurotic
  • Depressive Disorder
  • Grief
  • OCD
  • Panic Disorder
  • Personality Disorders
  • Phobia, Social
  • PTSD
  • Social Anxiety Disorder
  • Suicide

Intervention

Diagnostic Test:
Psychoanalysis
Case-specific psychoanalysis is performed, including the participant's background during birth.
Drug:
sertraline 50mg
After the initial assessment of 50 mg/d, the treatment dosage is determined at 100 mg/d.
Duloxetine 20 MG
Duloxetine is used with 20 mg/night for subsidiary effects with sertraline.
Behavioral:
Cognitive Behavioral Therapy
CBT is tailored to the participant's current activities and life decisions.

Locations

Country Name City State
China Residential Address Chongqing Chongqing

Sponsors (2)

Lead Sponsor Collaborator
Yang I. Pachankis, PhD S for Science

Country where clinical trial is conducted

China, 

References & Publications (14)

Pachankis Y. Jeopardies in human security and politicization of COVID-19. Ethics Med Public Health. 2023 Apr;27:100871. doi: 10.1016/j.jemep.2023.100871. Epub 2023 Feb 1. No abstract available. — View Citation

Yang IP. A Self--help Guide to Psychoanalysis in Cisgender Homosexual Male. Journal of Marketing Management and Consumer Behavior. 2022; 4(2), 93-110.

Yang IP. An Evidence-driven Research to the Transgressions of Geneva Conventions by the Communist Party of China Led Autocratic Regime. International Journal of Scientific & Engineering Research. 2022; 13(10): 249-266.

Yang IP. Correlating Nuclear Sciences to Biochemistry - Mini-review on the Environmental Physiological Impact of Electronic Warfare on Public Health. Journal of Clinical Chemistry. 2022; 1(2): 1-5.

Yang IP. Dictatorial Psychopathological Commination in Server-Side Public Mental & Psychological Menace. Biomedical Science and Clinical Research. 2023; 2(2): 173-184.

Yang IP. Mass Surveillance, Behavioural Control, and Psychological Coercion - The Moral Ethical Risks in Commercial Devices. In: Wyld, D. C. & Nagamalai, D. (Eds.) Computer Science and Information Technology. 2022; 151-168. AIRCC Publishing Corporation.

Yang IP. Proton Decay Reconstruction in Conscious Phenomenon - Literature Review on MRI, EEG, and PET Technologies. Advances in Sexual & Reproductive Health Research. 2022; 1(1): 128-130.

Yang IP. Proton Paths of Cardiac Immune Reflex. Online Journal of Cardiology Research & Reports. 2023; 7(1): 000655.

Yang IP. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.

Yang IP. Targeted Human Trafficking - The Wars between Proxy and Surrogated Economy. International Journal of Scientific & Engineering Research. 2022; 13(7): 398-409.

Yang IP. Technical Analysis on the Cyber Organizational Criminology of Dictatorial Military Conducts -- Experience from Human Trafficking and Coercions by Military Cyber Aggressions. International Journal of Security, Privacy and Trust Management. 2022; 11(3): 1-19.

Yang IP. The Cultural Revisionist Element behind P. R. China's Neo-Nazism: A Cross-cultural and Cross-religion Research. International Journal of Advanced Multidisciplinary Research and Studies. 2022; 2(4): 435-451.

Yang IP. What Do We Need in Adolescence?. Journal of Addiction Research. 2023; 7(1): 7-8.

Yang IP. Why Should LGBTQI Marriage Be Legalized. Academia Letters. 2022; Article 5157.

* Note: There are 14 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Hamilton Anxiety Rating Scale (HAM-A) 90 days
Primary Generalized Anxiety Disorder (GAD-7) 90 days
Primary Dissociative Experiences Scale - II (DES-II) 90 days
Primary The Defeat Scale (D Scale) 90 days
Primary Yale-Brown Obsessive Compulsive Scale (Y-BOCS) 90 days
Primary Severity Measure for Agoraphobia-Adult 90 days
Primary BPD Check List 90 days
Primary Rosenberg Self-Esteem Scale (RSE) 90 days
Primary Young Schema Questionnaire (YSQ) 90 days
Primary Personality Belief Questionnaire (PBQ) 90 days
Primary Behavioral Satisfaction Questionnaire (X axis) The X axis score total range -150 to +140, from self-centrism (passive-aggressiveness) to proactive social behaviors. 90 days
Primary Behavioral Satisfaction Questionnaire (Y axis) The Y axis score total range -200 to +195, from inhibition to excitation of the hypothalamic-pituitary-adrenal (HPA) axis in daily lives. 90 days
Secondary Heart Rate Heart rate is used to correlate to the participant's mode change. 90 days
Secondary Systolic Blood Pressure Systolic blood pressure is measured for reference on psychoneurotic correlations. 90 days
Secondary Diastolic Blood Pressure Diastolic blood pressure is measured for reference on possible side-effects with dizziness etc. 90 days
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