NCT02377505

Brief Summary

This study aims at assessing efficacy and safety of Deep Brain Stimulation (DBS) for treatment of patients with treatment resistant schizophrenia, by means of a random, controlled and crossed study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

January 1, 2013

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 26, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 3, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

4.1 years

First QC Date

February 26, 2015

Last Update Submit

February 17, 2020

Conditions

Refractory Schizophrenia

Keywords

Treatment-Resistant SchizophreniaDeep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Syndrome Scale for Schizophrenia (PANSS)

    Scale to assess changes in schizophrenia' symptoms

    Changes from baseline score to 1-3 weeks scores and to fortnightly scores until the end of trial (12 months)

Secondary Outcomes (12)

  • Clinical Global Impression-Schizophrenia (CGI-SCH)

    Changes from baseline score to 1-12 months scores

  • Global Functioning Scale (GFS)

    Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

  • Social Functioning Scale (SFS)

    Changes from baseline score to 1-3 weeks scores and to 1-12 months scores

  • Personal and Social Performance (PSP)

    Changes from baseline score to 1-12 months scores

  • Psychotic Symptom Rating Scales (PSYRATS)

    Changes from baseline score to 1-12 months scores

  • +7 more secondary outcomes

Study Arms (2)

On-Stimulation

ACTIVE COMPARATOR

Disease condition is assessed with stimulation turned "on"

Device: On-Stimulation

Off-Stimulation

PLACEBO COMPARATOR

Disease condition is assessed with stimulation turned "off"

Device: Off-Stimulation

Interventions

On-StimulationDEVICE

The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "on"

On-Stimulation
Off-StimulationDEVICE

The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is "off"

Off-Stimulation

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female aged between 18 and 55 years.
  • DSM IV-TR diagnosis of schizophrenia for at least 3 years prior to the screening visit.
  • Determined to be treatment-resistant as demonstrated by:
  • Persistence of positive symptoms which have not responded to appropriate treatments for at least 2 years.
  • Inadequate response from adequate trials of two different classes of antipsychotic drugs (not including clozapine), at least 8 weeks.
  • Inadequate response from adequate trial of clozapine, at least 3 months, or unable to tolerate clozapine because of intolerable side effects.
  • ECT is contraindicated or have failed to produce a maintained response.
  • Persistence of positive symptoms defined as i) requiring a score of 4 (mild) or more on at least 2 of the next PANSS items: delusions, hallucinatory behavior, suspiciousness and unusual thought content; or as ii) requiring a score of 6 (severe) or more on at least 1 of the above PANSS items.
  • Current CGI score 6 or more
  • Stable antipsychotic treatment for last 2 months.
  • Women of childbearing age using medically approved contraceptive methods.
  • Adequate familiar or social support during all study procedures.

You may not qualify if:

  • MRI (Magnetic Resonance Imaging) contraindication to stimulation or contraindications for MRI
  • History of epilepsy or clozapine-induced seizures, where use of anticonvulsants was needed
  • Current suicidal ideation, plan or intent for self-harm during last 2 months.
  • Evidence of global cognitive impairment.
  • Current acute, serious or unstable illnesses.
  • History of substance abuse (other than tobacco or caffeine).
  • Comorbid axis I or II DSM IV-TR disorders.
  • Female patients who are pregnant or breastfeeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FIDMAG Germanes Hospitalàries Research Foundation

Sant Boi de Llobregat, Barcelona, 08035, Spain

Location

Department of Psychiatry. Hospital Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Related Publications (3)

  • Salgado-Lopez L, Pomarol-Clotet E, Roldan A, Rodriguez R, Molet J, Sarro S, Alvarez E, Corripio I. Letter to the Editor: Deep brain stimulation for schizophrenia. J Neurosurg. 2016 Jul;125(1):229-30. doi: 10.3171/2015.12.JNS152874. Epub 2016 Apr 22. No abstract available.

    PMID: 27104842RESULT

  • Corripio I, Sarro S, McKenna PJ, Molet J, Alvarez E, Pomarol-Clotet E, Portella MJ. Clinical Improvement in a Treatment-Resistant Patient With Schizophrenia Treated With Deep Brain Stimulation. Biol Psychiatry. 2016 Oct 15;80(8):e69-70. doi: 10.1016/j.biopsych.2016.03.1049. Epub 2016 Mar 10. No abstract available.

    PMID: 27113497RESULT

  • Corripio I, Roldan A, Sarro S, McKenna PJ, Alonso-Solis A, Rabella M, Diaz A, Puigdemont D, Perez-Sola V, Alvarez E, Arevalo A, Padilla PP, Ruiz-Idiago JM, Rodriguez R, Molet J, Pomarol-Clotet E, Portella MJ. Deep brain stimulation in treatment resistant schizophrenia: A pilot randomized cross-over clinical trial. EBioMedicine. 2020 Jan;51:102568. doi: 10.1016/j.ebiom.2019.11.029. Epub 2020 Jan 8.

    PMID: 31927311RESULT

MeSH Terms

Conditions

Schizophrenia, Treatment-Resistant

Condition Hierarchy (Ancestors)

SchizophreniaSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • Iluminada Corripio, MD, PhD

    Department of Psychiatry. Hospital Santa Creu i Sant Pau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 26, 2015

First Posted

March 3, 2015

Study Start

January 1, 2013

Primary Completion

February 1, 2017

Study Completion

December 23, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)