Psychiatric Orders in Psychoanalytic Treatment of ASD

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.

Study Overview

• Status: Active, not recruiting
• Conditions: PTSD; Anxiety Disorders; OCD; Borderline Personality Disorder; Social Anxiety Disorder; Depression, Anxiety; Depression, Unipolar; ADHD - Combined Type; Grief; Depression Anxiety Disorder; Depression and Suicide; Autism Spectrum Disorder High-Functioning; Avoidant Personality Disorder; Agoraphobia With Panic Attacks; Depression; Psychoneurotic; Depression, Reactive; Panic Disorder With Agoraphobia, Severe Agoraphobic Avoidance and Mild Panic Attacks; Stockholm Syndrome; Separation Insecurity
• Intervention / Treatment: Diagnostic test: Psychoanalysis; Drug: sertraline 50mg; Drug: Duloxetine 20 MG; Behavioral: Cognitive Behavioral Therapy

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• China
  • Chongqing
    • Chongqing, Chongqing, China, 402762
      • Residential Address

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Persons with ASD.

Exclusion Criteria:

• Severe ASD cases with central nerve system complications.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate	Heart rate is used to correlate to the participant's mode change.	90 days
Systolic Blood Pressure	Systolic blood pressure is measured for reference on psychoneurotic correlations.	90 days
Diastolic Blood Pressure	Diastolic blood pressure is measured for reference on possible side-effects with dizziness etc.	90 days

Collaborators and Investigators

• Sponsor: Yang I. Pachankis, PhD
• Collaborators: S for Science

Publications and helpful links

General Publications

• Yang IP. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.
• 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.
• Yang IP. Dictatorial Psychopathological Commination in Server-Side Public Mental & Psychological Menace. Biomedical Science and Clinical Research. 2023; 2(2): 173-184.
• Yang IP. Proton Paths of Cardiac Immune Reflex. Online Journal of Cardiology Research & Reports. 2023; 7(1): 000655.
• Yang IP. What Do We Need in Adolescence?. Journal of Addiction Research. 2023; 7(1): 7-8.
• 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. 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. 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. 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. 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. Targeted Human Trafficking - The Wars between Proxy and Surrogated Economy. International Journal of Scientific & Engineering Research. 2022; 13(7): 398-409.
• Yang IP. Why Should LGBTQI Marriage Be Legalized. Academia Letters. 2022; Article 5157.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): September 1, 2023
• Study Completion (Estimated): December 1, 2023

Study Registration Dates

• First Submitted: June 11, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 26, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Trauma and Stressor Related Disorders; Self-Injurious Behavior; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Phobic Disorders; Personality Disorders; Depression; Depressive Disorder; Anxiety Disorders; Suicide; Autism Spectrum Disorder; Borderline Personality Disorder; Phobia, Social; Panic Disorder; Agoraphobia; Adjustment Disorders; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Selective Serotonin Reuptake Inhibitors; Sertraline; Duloxetine Hydrochloride
• Other Study ID Numbers: ASD-Psy-000; ASD-000000 (Other Grant/Funding Number: S for Science)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD is being shared on Open Science Framework with the DOI: 10.17605/OSF.IO/2MGJK.
• IPD Sharing Time Frame: The data will be available during the study process, and the archives after completion will stay available.
• IPD Sharing Access Criteria: Public.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Study Data/Documents

1. Individual Participant Data Set
2. Social Circumstances and Events
   Information identifier: zenodo.7382529
3. Cyber-Social Circumstances and Events
   Information identifier: zenodo.6942208
4. Social Circumstances and Events
   Information identifier: zenodo.7188211
5. Cyber-Social Circumstances and Events
   Information identifier: zenodo.6941906
6. Cyber-Social Circumstances and Events
   Information identifier: zenodo.6952516
7. Analytic Code
   Information identifier: zenodo.7022873
   Information comments: The technological-psychoanalytic mass psychological observation and analysis schemes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes