Psychiatric Orders in Psychoanalytic Treatment of ASD

Sponsor
Yang I. Pachankis, PhD (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05930912
Collaborator
S for Science (Other)
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1
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Study Details

Study Description

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.

Study Design

Study Type:
Observational
Actual Enrollment :
1 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Psychiatric Orders in Psychoanalytic Treatment of ASD
Actual Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Hamilton Anxiety Rating Scale (HAM-A) [90 days]

    2. Generalized Anxiety Disorder (GAD-7) [90 days]

    3. Dissociative Experiences Scale - II (DES-II) [90 days]

    4. The Defeat Scale (D Scale) [90 days]

    5. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [90 days]

    6. Severity Measure for Agoraphobia-Adult [90 days]

    7. BPD Check List [90 days]

    8. Rosenberg Self-Esteem Scale (RSE) [90 days]

    9. Young Schema Questionnaire (YSQ) [90 days]

    10. Personality Belief Questionnaire (PBQ) [90 days]

    11. Behavioral Satisfaction Questionnaire (X axis) [90 days]

      The X axis score total range -150 to +140, from self-centrism (passive-aggressiveness) to proactive social behaviors.

    12. Behavioral Satisfaction Questionnaire (Y axis) [90 days]

      The Y axis score total range -200 to +195, from inhibition to excitation of the hypothalamic-pituitary-adrenal (HPA) axis in daily lives.

    Secondary Outcome Measures

    1. Heart Rate [90 days]

      Heart rate is used to correlate to the participant's mode change.

    2. Systolic Blood Pressure [90 days]

      Systolic blood pressure is measured for reference on psychoneurotic correlations.

    3. Diastolic Blood Pressure [90 days]

      Diastolic blood pressure is measured for reference on possible side-effects with dizziness etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Persons with ASD.
    Exclusion Criteria:
    • Severe ASD cases with central nerve system complications.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Residential Address Chongqing Chongqing China 402762

    Sponsors and Collaborators

    • Yang I. Pachankis, PhD
    • S for Science

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Yang I. Pachankis, PhD, PI, Pachankis, Yang I., M.D.
    ClinicalTrials.gov Identifier:
    NCT05930912
    Other Study ID Numbers:
    • ASD-Psy-000
    • ASD-000000
    First Posted:
    Jul 5, 2023
    Last Update Posted:
    Jul 5, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 5, 2023