SchizophreniaNCT05746494

The Efficacy of Neural Stimulation in Individuals With Schizophrenia

A study testing tDCS in people with Schizophrenia and Schizo Affective Disorder, run by The University of Texas at Dallas at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to understand the relationship between psychotic symptoms and social functioning in individuals with schizophrenia spectrum disorders. Our goal is to determine whether stimulating the brain using transcranial Direct Current Stimulation (tDCS) can improve symptoms and daily functioning. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia, Schizo Affective Disorder
What is being tested?: tDCS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 21 Nov 2022to 1 Aug 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Age = 18-64
Diagnosed with schizophrenia or schizoaffective disorder
Having current (in the past week) or recent (in the past month) paranoia

Who cannot join

Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ < 70
Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
History of electroconvulsive therapy
Lack of proficiency in English
Substance use disorder not in remission in the past 6 months
Any implanted devices such as pace maker, neurostimulator
Pregnancy

Trial locations and contacts

1 site in 1 country.

United States1 site

The Unversity of Texas at Dallas
Richardson, Texas, 75080

Other trials in United States

About this study

Read the detailed description

Paranoid ideation is a common delusion experienced by individuals with schizophrenia spectrum disorders (SSD) that negatively impacts social interactions and quality of life. Therefore, efforts to reduce paranoid thinking via neuromodulation techniques [e.g., transcranial direct current stimulation (tDCS)] are in development, with amygdala-prefrontal cortex (PFC) circuits targeted as critical components of the neural mechanisms underlying paranoia.

This project aims to alleviate paranoia and improve social functioning in individuals with SSD by implementing tDCS to ventrolateral PFC. A double-blind, within-subjects, crossover design will be used to compare the effects of active vs. sham tDCS. Ecological Momentary Assessments (EMA) will also be utilized to quantify any delayed stimulation effects in daily social interactions.

Conditions: Schizophrenia, Schizo Affective Disorder
Being tested: tDCS
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

tDCSDevice
active anodal tDCS and sham tDCS

Study groups in NCT05746494
Study group	Role	What they receive
Active anodal tDCS first, then Sham tDCS	Experimental	Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing. Receives: Device: tDCS
Sham tDCS first, then Active anodal tDCS	Sham comparator	Sham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention. Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

The State Social Paranoia Scale (SSPS)
Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.
Measured: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation
Ecological Momentary Assessment (EMA)-Based Paranoia
Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can't trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.
Measured: Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
Birchwood Social Functioning Scale (SFS)
Social functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).
Measured: The assessment was completed 30 minutes after completion of the active/sham stimulation
Ecological Momentary Assessment (EMA)-Based Social Functioning
Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).
Measured: Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)

Secondary outcomes (4)

The Trustworthiness Task
Paranoid ideation was measured by the Trustworthiness Task. This task requires participants to indicate how much they trust each of 60 grayscale facial stimuli along a 7-point Likert scale (-3 = very untrustworthy, 3 = very trustworthy). Total scores were calculated by averaging across responses and hence varied from -3 to +3, with higher values indicating a greater tendency to trust others.
Measured: The assessment was completed 30 minutes after completion of the active/sham stimulation
The Scrambled-sentences Task (SST)
Paranoid ideation was measured by the Scrambled-sentences task (SST). This task measures the level of paranoia by asking participants to create sentences of either paranoid or nonparanoid meanings, with a greater percentage indicating a higher level of paranoid interpretation bias (range = 0-1).
Measured: The assessment was completed 30 minutes after completion of the active/sham stimulation
The Ambiguous Intentions Hostility Questionnaire (AIHQ)
Paranoid ideation was measured by the Ambiguous Intentions Hostility Questionnaire (AIHQ). Three subscores were generated: AIHQ (blame) (ranging from 3-16, with a higher score indicating a higher level of blaming tendency), AIHQ (hostility) (ranging from 1-5, with a higher score indicating a higher level of hostility), AIHQ (aggression) (ranging from 1-5, with a higher score indicating a higher level of aggression).
Measured: The assessment was completed 30 minutes after completion of the active/sham stimulation
The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)
Paranoid ideation was measured by the Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS). PID-5-HS contains 10 self-report items assessing pathological hostility. A total score (range from 0-30) was generated to reflect overall hostility level, with higher total scores indicating more hostility.
Measured: The assessment was completed 30 minutes after completion of the active/sham stimulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

21 Nov 20221 Aug 2024

First posted27 Feb 2023
Study start21 Nov 2022
Primary completion1 Aug 2024
Study completion1 Aug 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05746494
Sponsor's protocol ID: 22-630
Status last verified: Feb 2025
First submitted: 2 Feb 2023
Last updated: 26 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Fan L, Carrico S, Zhu Y, Ackerman RA, Pinkham AE. Transcranial Direct Current Stimulation Improves Paranoia and Social Functioning in Schizophrenia: A Randomized Clinical Trial. Biol Psychiatry. 2025 Jul 15;98(2):135-143. doi: 10.1016/j.biopsych.2025.01.011. Epub 2025 Jan 22.
PubMed 39855408

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy of Neural Stimulation in Individuals With Schizophrenia
ClinicalTrials.gov ID: NCT05746494
Acronym / sponsor ID: 22-630
Conditions: Schizophrenia, Schizo Affective Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: The University of Texas at DallasUniversity, hospital or other
Study start: 21 Nov 2022 (actual)
Primary completion: 1 Aug 2024 (actual)
Study completion: 1 Aug 2024 (actual)
First posted: 27 Feb 2023 (actual)
Results: Posted 26 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: Participants will complete active and sham simulation sessions in a randomized, counterbalanced order about one week apart.

Arm	Type	Receives
Active anodal tDCS first, then Sham tDCS	Experimental	Device: tDCSActive anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); sham stimulation (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing.
Sham tDCS first, then Active anodal tDCS	Sham comparator	Device: tDCSSham tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing; Washout (about 1 week); Active anodal tDCS (40 minutes; divided into two 20-minutes sessions) followed by behavioral testing Intervention.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Age = 18-64
Diagnosed with schizophrenia or schizoaffective disorder
Having current (in the past week) or recent (in the past month) paranoia

Key exclusion criteria (8 listed)

Presence or history of a pervasive developmental disorder or mental retardation as defined by IQ < 70
Presence or history of neurological or medical disorders that contraindicate neural stimulation (e.g. presence or history of epilepsy, seizures, etc.)
Demonstrating sensory limitations, including uncorrectable visual or hearing impairments that interfere with assessment
History of electroconvulsive therapy
Lack of proficiency in English

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
tDCSactive anodal tDCS and sham tDCS	Device	Active anodal tDCS first, then Sham tDCS, Sham tDCS first, then Active anodal tDCS

Primary outcome

The State Social Paranoia Scale (SSPS)
Time frame: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation
Paranoid ideation was measured by the State Social Paranoia Scale (SSPS). Participants indicated how much they agree with each of 20 statements (e.g., "Someone was hostile towards me", "Someone was trying to isolate me") using a 5-point Likert scale (1 = do not agree, 5 = totally agree). Scores range from 20-100, and higher scores represent higher state paranoid ideation.
Ecological Momentary Assessment (EMA)-Based Paranoia
Time frame: Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
Paranoid ideation was measured by Ecological Momentary Assessment (EMA), which involved questions about feelings of paranoia in daily life. The paranoia-related question is as follows: "Since the past alarm, how much have you had thoughts that you really can't trust other people?" The score for this item ranges from 1 to 7, with a higher score indicating a higher level of paranoid thinking.
Birchwood Social Functioning Scale (SFS)
Time frame: The assessment was completed 30 minutes after completion of the active/sham stimulation
Social functioning was measured by the Birchwood Social Functioning Scale (SFS). This scale measures social adjustment based on self-reports (4- or 5-point scales), with higher total scores indicating better social functioning (range = 0-223).
Ecological Momentary Assessment (EMA)-Based Social Functioning
Time frame: Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit)
Social functioning was measured by Ecological Momentary Assessment (EMA) (i.e., questions about daily interactions with others). Two subscores were generated: social interaction frequency (score ranges from 0-5, a higher score indicates more frequent social interactions), social interaction motivation and experience (scores range from 1-7, a higher score indicates higher motivations to interact with others and better experiences during these interactions).

4 secondary outcomes

The Trustworthiness Task
Time frame: The assessment was completed 30 minutes after completion of the active/sham stimulation
The Scrambled-sentences Task (SST)
Time frame: The assessment was completed 30 minutes after completion of the active/sham stimulation
The Ambiguous Intentions Hostility Questionnaire (AIHQ)
Time frame: The assessment was completed 30 minutes after completion of the active/sham stimulation
The Hostility Scale of the Personality Inventory for DSM-5 (PID-5-HS)
Time frame: The assessment was completed 30 minutes after completion of the active/sham stimulation

Results and safety

Results posted to the registry on 26 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Active Anodal tDCS First, Then Sham tDCS	26	26
Sham tDCS First, Then Active Anodal tDCS	24	24

Primary outcome: The State Social Paranoia Scale (SSPS)

Time frame: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation. Mean (Standard Deviation). Unit: The change score of SSPS (pre - post)

Measure	Active Visit n = 50	Sham Visit n = 50
Value	9.72 (14.61)	3.90 (11.56)

Active Visit vs Sham Visit: p = 0.023, ANOVA

Primary outcome: Ecological Momentary Assessment (EMA)-Based Paranoia

Time frame: Change in daily paranoia feelings was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit). Mean (Standard Deviation). Unit: units on a scale

Measure	EMA-baseline n = 47	EMA-active n = 47	EMA-sham n = 47
Value	3.78 (1.72)	3.61 (0.91)	3.96 (1.85)

EMA-baseline vs EMA-active vs EMA-sham: p = 0.042, Multilevel Modeling

Population analysed: Only 47 (out of 50) participants completed this measure.

Primary outcome: Birchwood Social Functioning Scale (SFS)

Time frame: The assessment was completed 30 minutes after completion of the active/sham stimulation. Mean (Standard Deviation). Unit: units on a scale

Measure	Active Visit n = 50	Sham Visit n = 50
Value	114.21 (22.35)	114.59 (27.54)

Active Visit vs Sham Visit: p = 0.980, t-test, 2 sided

Primary outcome: Ecological Momentary Assessment (EMA)-Based Social Functioning

Time frame: Change in daily interactions was assessed from the pre-stimulation EMA period (7 days before the stimulation visit) to the post-stimulation EMA period (7 days after the stimulation visit). Mean (Standard Deviation). Unit: score on a scale

Measure	EMA-baseline n = 47	EMA-active n = 47	EMA-sham n = 47
Social interaction frequency	0.97 (0.76)	0.91 (0.83)	0.92 (0.90)
Social interaction motivation and experience	3.74 (1.62)	4.08 (1.68)	3.71 (1.62)

EMA-baseline vs EMA-active vs EMA-sham: p = 0.010, Multilevel Modeling

Population analysed: Only 47 (out of 50) participants completed this measure.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Immediately after the stimulation visit, up to 24 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Active Visit	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Sham Visit	0 of 50 (0%)	0 of 50 (0%)	0 of 50

Limitations and caveats (from the sponsor): The inherent limitations of the assessment tools for measuring social functioning in the lab may have impacted the findings.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39855408Fan L, Carrico S, Zhu Y, Ackerman RA, Pinkham AE. Transcranial Direct Current Stimulation Improves Paranoia and Social Functioning in Schizophrenia: A Randomized Clinical Trial. Biol Psychiatry. 2025 Jul 15;98(2):135-143. doi: 10.1016/j.biopsych.2025.01.011. Epub 2025 Jan 22.
Individual participant dataSharing planned: No

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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?

A study testing tDCS in people with Schizophrenia and Schizo Affective Disorder, run by The University of Texas at Dallas at 1 site in United States.

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 3 inclusion and 8 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: finished, as of the sponsor's last update on 26 Feb 2025. 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 United States. 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 26 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The State Social Paranoia Scale (SSPS) (time frame: The assessment was completed before the stimulation and 30 minutes after completion of the active/sham stimulation). The study lists 4 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 NCT05746494, which also lists 1 linked publication.

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 26 Feb 2025.