PTSDNCT05930912
Psychiatric Orders in Psychoanalytic Treatment of ASD
An observational study of PTSD and Autism Spectrum Disorder High-Functioning, run by Yang I. Pachankis, PhD at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- PTSD, Autism Spectrum Disorder High-Functioning, OCD
- What is being tested?
- Psychoanalysis, sertraline 50mg and Duloxetine 20 MG
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Adult, Older adult
Study population: The study population is currently Asian, and the sociostructural environment of People's Republic of China is implied.
Who may be able to join
- Persons with ASD.
Who cannot join
- Severe ASD cases with central nerve system complications.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- PTSD, Autism Spectrum Disorder High-Functioning, OCD, Agoraphobia With Panic Attacks, Depression, Unipolar, Depression, Anxiety
- Being tested
- Psychoanalysis, sertraline 50mg, Duloxetine 20 MG, Cognitive Behavioral Therapy
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Depression, Anxiety Disorders, Suicide, Adjustment Disorders, Borderline Personality Disorder, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoanalysisDiagnostic test
Also called Psychodynamic analysis
Case-specific psychoanalysis is performed, including the participant's background during birth.
sertraline 50mgDrug
Also called SSRI
After the initial assessment of 50 mg/d, the treatment dosage is determined at 100 mg/d.
Duloxetine 20 MGDrug
Also called SNRI
Duloxetine is used with 20 mg/night for subsidiary effects with sertraline.
Cognitive Behavioral TherapyBehavioural
Also called CBT
CBT is tailored to the participant's current activities and life decisions.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Psychoanalysis; Drug: sertraline 50mg; Drug: Duloxetine 20 MG; Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Anxiety Rating Scale (HAM-A)
Measured: 90 days
Generalized Anxiety Disorder (GAD-7)
Measured: 90 days
Dissociative Experiences Scale - II (DES-II)
Measured: 90 days
The Defeat Scale (D Scale)
Measured: 90 days
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Measured: 90 days
Severity Measure for Agoraphobia-Adult
Measured: 90 days
BPD Check List
Measured: 90 days
Rosenberg Self-Esteem Scale (RSE)
Measured: 90 days
Young Schema Questionnaire (YSQ)
Measured: 90 days
Personality Belief Questionnaire (PBQ)
Measured: 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.
Measured: 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.
Measured: 90 days
Secondary outcomes (3)
Heart Rate
Heart rate is used to correlate to the participant's mode change.
Measured: 90 days
Systolic Blood Pressure
Systolic blood pressure is measured for reference on psychoneurotic correlations.
Measured: 90 days
Diastolic Blood Pressure
Diastolic blood pressure is measured for reference on possible side-effects with dizziness etc.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start1 Jun 2023
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yang I. Pachankis, PhD
- Collaborators
- S for Science
- Responsible party
- Sponsor-investigator, Yang I. Pachankis, PhD, Pachankis, Yang I., M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930912
- Sponsor's protocol ID
- ASD-Psy-000
- Other IDs
- ASD-000000
- Status last verified
- Jun 2023
- First submitted
- 11 Jun 2023
- Last updated
- 5 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is being shared on Open Science Framework with the DOI: 10.17605/OSF.IO/2MGJK.
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.
PubMed 36743192Yang 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 at a glance
From the registry record, last updated by the sponsor on 5 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychiatric Orders in Psychoanalytic Treatment of ASD
- ClinicalTrials.gov ID
- NCT05930912
- Acronym / sponsor ID
- ASD-Psy-000
- Conditions
- PTSD, Autism Spectrum Disorder High-Functioning, OCD, Agoraphobia With Panic Attacks, Depression, Unipolar, Depression, Anxiety
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Yang I. Pachankis, PhD
- Collaborators
- S for Science
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Case | – | Diagnostic Test: Psychoanalysis, Drug: sertraline 50mg, Drug: Duloxetine 20 MG, Behavioral: Cognitive Behavioral TherapyThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population is currently Asian, and the sociostructural environment of People's Republic of China is implied.
Key inclusion criteria (1 listed)
- Persons with ASD.
Key exclusion criteria (1 listed)
- Severe ASD cases with central nerve system complications.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PsychoanalysisAlso: Psychodynamic analysisCase-specific psychoanalysis is performed, including the participant's background during birth. | Diagnostic test | Participant Case |
| sertraline 50mgAlso: SSRIAfter the initial assessment of 50 mg/d, the treatment dosage is determined at 100 mg/d. | Drug | Participant Case |
| Duloxetine 20 MGAlso: SNRIDuloxetine is used with 20 mg/night for subsidiary effects with sertraline. | Drug | Participant Case |
| Cognitive Behavioral TherapyAlso: CBTCBT is tailored to the participant's current activities and life decisions. | Behavioural | Participant Case |
Primary outcome
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 90 days
Generalized Anxiety Disorder (GAD-7)
Time frame: 90 days
Dissociative Experiences Scale - II (DES-II)
Time frame: 90 days
The Defeat Scale (D Scale)
Time frame: 90 days
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
Time frame: 90 days
Severity Measure for Agoraphobia-Adult
Time frame: 90 days
BPD Check List
Time frame: 90 days
Rosenberg Self-Esteem Scale (RSE)
Time frame: 90 days
Young Schema Questionnaire (YSQ)
Time frame: 90 days
Personality Belief Questionnaire (PBQ)
Time frame: 90 days
Behavioral Satisfaction Questionnaire (X axis)
Time frame: 90 days
The X axis score total range -150 to +140, from self-centrism (passive-aggressiveness) to proactive social behaviors.
Behavioral Satisfaction Questionnaire (Y axis)
Time frame: 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.
3 secondary outcomes
Heart Rate
Time frame: 90 days
Systolic Blood Pressure
Time frame: 90 days
Diastolic Blood Pressure
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2023.
- BackgroundYang IP. Questions of COVID-19: Institutional Derogations of Global Health. Lambert Academic Publishing. 2023. ISBN: 978-6206153849.
- Background: PubMed 36743192Pachankis 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.
- BackgroundYang IP. Dictatorial Psychopathological Commination in Server-Side Public Mental & Psychological Menace. Biomedical Science and Clinical Research. 2023; 2(2): 173-184.
- BackgroundYang IP. Proton Paths of Cardiac Immune Reflex. Online Journal of Cardiology Research & Reports. 2023; 7(1): 000655.
- BackgroundYang IP. What Do We Need in Adolescence?. Journal of Addiction Research. 2023; 7(1): 7-8.
- BackgroundYang 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.
- BackgroundYang 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.
- BackgroundYang 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.
- BackgroundYang 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.
- BackgroundYang 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.
- BackgroundYang IP. A Self--help Guide to Psychoanalysis in Cisgender Homosexual Male. Journal of Marketing Management and Consumer Behavior. 2022; 4(2), 93-110.
- BackgroundYang 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.
- Individual participant dataSharing planned: Yes. IPD is being shared on Open Science Framework with the DOI: 10.17605/OSF.IO/2MGJK.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PTSD and Autism Spectrum Disorder High-Functioning, run by Yang I. Pachankis, PhD at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Anxiety Rating Scale (HAM-A) (time frame: 90 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05930912, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2023.