NCT05930912

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

July 5, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 11, 2023

Last Update Submit

June 26, 2023

Conditions

Outcome Measures

Primary Outcomes (12)

  • Hamilton Anxiety Rating Scale (HAM-A)

    90 days

  • Generalized Anxiety Disorder (GAD-7)

    90 days

  • Dissociative Experiences Scale - II (DES-II)

    90 days

  • The Defeat Scale (D Scale)

    90 days

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    90 days

  • Severity Measure for Agoraphobia-Adult

    90 days

  • BPD Check List

    90 days

  • Rosenberg Self-Esteem Scale (RSE)

    90 days

  • Young Schema Questionnaire (YSQ)

    90 days

  • Personality Belief Questionnaire (PBQ)

    90 days

  • 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

  • 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 Outcomes (3)

  • Heart Rate

    90 days

  • Systolic Blood Pressure

    90 days

  • Diastolic Blood Pressure

    90 days

Study Arms (1)

Participant Case

The participant started taking SNRI duloxetine 20 mg/night in Jan. 2023, and changed to SSRI sertraline 50 mg/d in Mar. 2023. The apparent positive psychedelic effects did not take effect until increased dosage to sertraline 100mg/d after around one week in Jun. 2023. Duloxetine is planned to be added to the mix thereon.

Diagnostic Test: PsychoanalysisDrug: sertraline 50mgDrug: Duloxetine 20 MGBehavioral: Cognitive Behavioral Therapy

Interventions

PsychoanalysisDIAGNOSTIC_TEST

Case-specific psychoanalysis is performed, including the participant's background during birth.

Also known as: Psychodynamic analysis
Participant Case

After the initial assessment of 50 mg/d, the treatment dosage is determined at 100 mg/d.

Also known as: SSRI
Participant Case

Duloxetine is used with 20 mg/night for subsidiary effects with sertraline.

Also known as: SNRI
Participant Case

CBT is tailored to the participant's current activities and life decisions.

Also known as: CBT
Participant Case

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population is currently Asian, and the sociostructural environment of People's Republic of China is implied.

You may qualify if:

  • Persons with ASD.

You may not qualify if:

  • Severe ASD cases with central nerve system complications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Residential Address

Chongqing, Chongqing Municipality, 402762, China

Location

Related Publications (14)

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

    BACKGROUND
  • 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.

    PMID: 36743192BACKGROUND
  • Yang IP. Dictatorial Psychopathological Commination in Server-Side Public Mental & Psychological Menace. Biomedical Science and Clinical Research. 2023; 2(2): 173-184.

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

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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

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

    BACKGROUND
  • 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.

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

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

    BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticDepressive DisorderDepressionAnxiety DisordersSuicideAdjustment DisordersBorderline Personality DisorderPhobia, SocialPersonality Disorders

Interventions

SertralineDuloxetine HydrochlorideSerotonin and Noradrenaline Reuptake InhibitorsCognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersMood DisordersBehavioral SymptomsBehaviorSelf-Injurious BehaviorPhobic Disorders

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsThiophenesSulfur CompoundsHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNeurotransmitter Uptake InhibitorsMembrane Transport ModulatorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesNeurotransmitter AgentsPhysiological Effects of DrugsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

June 11, 2023

First Posted

July 5, 2023

Study Start

June 1, 2023

Primary Completion

September 1, 2023

Study Completion

December 1, 2023

Last Updated

July 5, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

IPD is being shared on Open Science Framework with the DOI: 10.17605/OSF.IO/2MGJK.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
The data will be available during the study process, and the archives after completion will stay available.
Access Criteria
Public.
More information

Available IPD Datasets

Individual Participant Data Set Access
Social Circumstances and Events (zenodo.7382529)Access
Cyber-Social Circumstances and Events (zenodo.6942208)Access
Social Circumstances and Events (zenodo.7188211)Access
Cyber-Social Circumstances and Events (zenodo.6941906)Access
Cyber-Social Circumstances and Events (zenodo.6952516)Access
Analytic Code (zenodo.7022873)Access

Locations