NCT02951208

Brief Summary

Negative symptoms, which include the loss of motivation, social withdrawal and reduced emotional expression are prominent in youth at clinical high risk (CHR) for psychosis. These negative symptoms lead to significant functional impairment and enduring disability in these youth. At present, there are no established treatments for negative symptoms. Recent evidence from independent studies, however, suggests two promising novel treatment approaches for negative symptoms, transcranial direct current stimulation (tDCS), and computerized remediation strategies. The primary aim of this study is to evaluate if tDCS combined with a virtual reality-based computerized remediation (VR) is effective for treating negative symptoms in CHR youth, thereby mitigating the enduring functional disability these symptoms cause.

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
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

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

October 1, 2016

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

October 28, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 1, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

4.9 years

First QC Date

October 28, 2016

Last Update Submit

May 5, 2020

Conditions

Clinical High Risk for Psychosis

Outcome Measures

Primary Outcomes (1)

  • Scale of Prodromal Symptoms - Negative Subscale (SOPS-Neg)

    8 weeks

Secondary Outcomes (14)

  • Scale of Prodromal Symptoms - Positive Subscale (SOPS-Pos)

    8 weeks

  • Global Function: Role scale

    8 weeks

  • Global Function: Social scale

    8 weeks

  • Beck Scale for Suicidal Ideation (BSS)

    4 weeks

  • Calgary Depression Scale for Schizophrenia

    4 weeks

  • +9 more secondary outcomes

Study Arms (2)

Active tDCS + Active VR

EXPERIMENTAL

Active tDCS over the left DLPFC (30 minutes) combined with active VR motivation training (60 minutes), administered 3 times per week for 4 weeks.

Device: Active tDCSBehavioral: Active VR Motivation Training

Sham tDCS + Sham VR

SHAM COMPARATOR

Sham tDCS over the left DLPFC (30 minutes) combined with sham VR motivation training (60 minutes), administered 3 times per week for 4 weeks.

Device: Sham tDCSBehavioral: Sham VR Motivation Training

Interventions

Active tDCSDEVICE

Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.

Also known as: Active Transcranial Direct Current Stimulation
Active tDCS + Active VR
Active VR Motivation TrainingBEHAVIORAL

Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.

Active tDCS + Active VR
Sham tDCSDEVICE

Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.

Also known as: Sham Transcranial Direct Current Stimulation
Sham tDCS + Sham VR
Sham VR Motivation TrainingBEHAVIORAL

Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.

Sham tDCS + Sham VR

Eligibility Criteria

Age16 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • between the ages of 16 and 30;
  • meet CHR criteria for a psychosis risk syndrome determined by the Structured Interview for Prodromal Symptoms (SIPS);
  • have a Scale of Prodromal Symptoms (SOPS) negative subscale (SOPS-Neg) score of \> 11, with at least one negative symptom of at least moderate severity (i.e., ≥ 3)

You may not qualify if:

  • meet criteria for a current or lifetime psychotic disorder;
  • have an IQ \< 70;
  • a history of seizures or clinically significant neurological disorder that may contribute to prodromal symptoms.
  • have been involved in another treatment study in the past 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M5T 1R8, Canada

RECRUITING

Related Links

Study Officials

  • George Foussias, MD PhD FRCPC

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

George Foussias, MD PhD FRCPC

CONTACT

416-535-8501george.foussias@camh.ca

Jessica D'Arcey

CONTACT

416-535-8501jessica.darcey@camh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinician Scientist

Study Record Dates

First Submitted

October 28, 2016

First Posted

November 1, 2016

Study Start

October 1, 2016

Primary Completion

September 1, 2021

Study Completion

September 1, 2021

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)