Depersonalization DisorderPERSONANCT02476435

Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation

A study testing Active rTMS in people with Depersonalization Disorder, run by Centre Hospitalier St Anne at 2 sites in France.

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 assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Depersonalization Disorder
What is being tested?: Active rTMS
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 81 participants
Where: 2 sitesFrance
Study dates: 19 Jun 2015to 10 Oct 2022
Phase: Interventional
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients:
Outpatients aged over 18 years old
Suffering from depersonalization disorder according to DSM IV-TR
Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and must be continued at the same dose(s) through the duration of the study.
Patient provided informed written consent
Patient covered by a contributory social security scheme

Show all 11Show fewer

Controls:
Aged over 18 years old
Absence of a personal history of psychiatric disorders
Provided informed written consent
Covered by a contributory social security scheme

Who cannot join

Patients:
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
history of neurosurgery,
neurosurgical ventriculoperitoneal bypass valves
personal and / or family history of seizures or epilepsy

Show all 21Show fewer

Dental device
Pregnant woman
Claustrophobic subjects
Not cooperating or agitated patients
Medications that reduce the seizure threshold, such as clozapine, bupropion, methadone and / or theophylline
Alcohol abuse and / or toxic substances in the last 12 months
Substance dependence except tobacco
Controls:
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
neurosurgical ventriculoperitoneal bypass valves
Claustrophobic subjects
Pregnant woman
Not cooperating or agitated patients
Dental device

Trial locations and contacts

2 sites in 1 country.

France2 sites

Saint-Antoine Hospital
Paris, 75012
Centre Hospitalier Sainte-Anne
Paris, 75014

Other trials in France

About this study

Official title: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.

The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.

Read the detailed description

Depersonalization disorder is characterised by a profound disruption of self-awareness. Depersonalization symptoms may occasionally arise (30 to 70% of the population) or may become chronic in depersonalization disorder. Its prevalence is around 2.4% in the general population. This disorder is particularly resistant to pharmacological treatments. This study is a randomized, double-blind, placebo-controlled study, and the investigators are testing the therapeutic efficacy of neuronavigated repetitive Transcranial Magnetic Stimulation (TMS) of right angular gyrus in patients with depersonalization disorder.

Conditions: Depersonalization Disorder
Being tested: Active rTMS, Placebo rTMS
Keywords: Depersonalization, Derealization, Embodiment, Emotional numbing, Transcranial magnetic stimulation, Angular gyrus, Temporo-parietal junction
Medical subject headings: Depersonalization

What participants receive

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

Active rTMSDevice
Also called Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
Placebo rTMSDevice
Also called Magstim Super-Rapid2, Neuronavigation system Visor (ANT)
Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks

Study groups in NCT02476435
Study group	Role	What they receive
Experimental = Active rTMS	Active comparator	Daily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks Receives: Device: Active rTMS
Sham Comparator = Sham rTMS	Placebo comparator	Daily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks Receives: Device: Placebo rTMS

What is being measured

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

Cambridge Depersonalization Scale (CDS)
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder.
The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Measured: At 3 weeks (in the end of the treatment)
Cambridge Depersonalization Scale (CDS)
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder.
The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Measured: At 1 month after the treatment
Cambridge Depersonalization Scale (CDS)
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder.
The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Measured: At 2 months after the treatment
Cambridge Depersonalization Scale (CDS)
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder.
The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Measured: At 3 months after the treatment

Secondary outcomes (3)

Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS
maintenance of reduction of at least 50% of the original score to the depersonalization scale of Cambridge.
Measured: At 3 months
Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
Measured: Baseline
Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
Anatomical MRI, ASL MRI, Resting State MRI, Diffusion MRI.
Measured: Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS)

Timeline

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

19 Jun 201510 Oct 2022

First posted19 Jun 2015 (estimated)
Study start19 Jun 2015
Primary completion10 Oct 2022
Study completion10 Oct 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Depersonalization DisorderStudies of the same condition, open and under way.
More trials run by Centre Hospitalier St AnneThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 81 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02476435
Sponsor's protocol ID: D14-P009
Acronym: PERSONA
Status last verified: Oct 2017
First submitted: 11 Jun 2015
Last updated: 1 Nov 2023
Results posted: No
Data monitoring committee: No

Publications

Blanke O, Ortigue S, Landis T, Seeck M. Stimulating illusory own-body perceptions. Nature. 2002 Sep 19;419(6904):269-70. doi: 10.1038/419269a.
PubMed 12239558
Blanke O. Multisensory brain mechanisms of bodily self-consciousness. Nat Rev Neurosci. 2012 Jul 18;13(8):556-71. doi: 10.1038/nrn3292.
PubMed 22805909
Sierra M, Berrios GE. The Cambridge Depersonalization Scale: a new instrument for the measurement of depersonalization. Psychiatry Res. 2000 Mar 6;93(2):153-64. doi: 10.1016/s0165-1781(00)00100-1.
PubMed 10725532
Farrer C, Frey SH, Van Horn JD, Tunik E, Turk D, Inati S, Grafton ST. The angular gyrus computes action awareness representations. Cereb Cortex. 2008 Feb;18(2):254-61. doi: 10.1093/cercor/bhm050. Epub 2007 May 8.
PubMed 17490989
Frith CD, Blakemore SJ, Wolpert DM. Abnormalities in the awareness and control of action. Philos Trans R Soc Lond B Biol Sci. 2000 Dec 29;355(1404):1771-88. doi: 10.1098/rstb.2000.0734.
PubMed 11205340
Mantovani A, Simeon D, Urban N, Bulow P, Allart A, Lisanby S. Temporo-parietal junction stimulation in the treatment of depersonalization disorder. Psychiatry Res. 2011 Mar 30;186(1):138-40. doi: 10.1016/j.psychres.2010.08.022. Epub 2010 Sep 15.
PubMed 20837362
Sierra M, Phillips ML, Ivin G, Krystal J, David AS. A placebo-controlled, cross-over trial of lamotrigine in depersonalization disorder. J Psychopharmacol. 2003 Mar;17(1):103-5. doi: 10.1177/0269881103017001712.
PubMed 12680746
Sierra M, Baker D, Medford N, David AS. Unpacking the depersonalization syndrome: an exploratory factor analysis on the Cambridge Depersonalization Scale. Psychol Med. 2005 Oct;35(10):1523-32. doi: 10.1017/S0033291705005325.
PubMed 16164776
Sierra M. Depersonalization disorder: pharmacological approaches. Expert Rev Neurother. 2008 Jan;8(1):19-26. doi: 10.1586/14737175.8.1.19.
PubMed 18088198
Sierra M, David AS. Depersonalization: a selective impairment of self-awareness. Conscious Cogn. 2011 Mar;20(1):99-108. doi: 10.1016/j.concog.2010.10.018. Epub 2010 Nov 17.
PubMed 21087873
Simeon D, Guralnik O, Hazlett EA, Spiegel-Cohen J, Hollander E, Buchsbaum MS. Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000 Nov;157(11):1782-8. doi: 10.1176/appi.ajp.157.11.1782.
PubMed 11058475
Simeon D, Kozin DS, Segal K, Lerch B, Dujour R, Giesbrecht T. De-constructing depersonalization: further evidence for symptom clusters. Psychiatry Res. 2008 Jan 15;157(1-3):303-6. doi: 10.1016/j.psychres.2007.07.007. Epub 2007 Oct 23.
PubMed 17959254

Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Depersonalization Disorder: Therapeutic Effect of Neuronavigated Repetitive Transcranial Stimulation of Right Angular Gyrus.
ClinicalTrials.gov ID: NCT02476435
Acronym / sponsor ID: PERSONA / D14-P009
Conditions: Depersonalization Disorder
Keywords: Depersonalization, Derealization, Embodiment, Emotional numbing, Transcranial magnetic stimulation, Angular gyrus, Temporo-parietal junction
Study type: Interventional
Recruitment status: Completed
Enrolment: 81 participants (actual)
Lead sponsor: Centre Hospitalier St AnneUniversity, hospital or other
Study start: 19 Jun 2015 (actual)
Primary completion: 10 Oct 2022 (actual)
Study completion: 10 Oct 2022 (actual)
First posted: 19 Jun 2015 (estimated)
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.

The purpose of this study is to assess the therapeutic efficacy of transcranial magnetic stimulation in patients with depersonalization disorder.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Experimental = Active rTMS	Active comparator	Device: Active rTMSDaily rTMS with Active coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks
Sham Comparator = Sham rTMS	Placebo comparator	Device: Placebo rTMSDaily rTMS with Sham coil 30 minutes of 1Hz rTMS, 5 days per week, for 3 weeks

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Outpatients aged over 18 years old
Suffering from depersonalization disorder according to DSM IV-TR
Patients currently on DPD medication must be at the same stable dose(s) at least 2 months and must be continued at the same dose(s) through the duration of the study.
Patient provided informed written consent
Patient covered by a contributory social security scheme

Key exclusion criteria (21 listed)

Patients:
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
Intracranial implants (e.g. aneurysms clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
history of neurosurgery,
neurosurgical ventriculoperitoneal bypass valves

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
Active rTMSAlso: Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeksStrong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks	Device	Experimental = Active rTMS
Placebo rTMSAlso: Magstim Super-Rapid2, Neuronavigation system Visor (ANT)Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks	Device	Sham Comparator = Sham rTMS

Primary outcome

Cambridge Depersonalization Scale (CDS)
Time frame: At 3 weeks (in the end of the treatment)
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder. The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Cambridge Depersonalization Scale (CDS)
Time frame: At 1 month after the treatment
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder. The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Cambridge Depersonalization Scale (CDS)
Time frame: At 2 months after the treatment
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder. The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale
Cambridge Depersonalization Scale (CDS)
Time frame: At 3 months after the treatment
The CDS is a comprehensive instrument containing 29 items addressing the complaints classically associated with the depersonalization syndrome. Each item is rated on two Likert scales for frequency and duration of the experience. The global score of the scale is the arithmetic sum of all items (range 0-290). High scores reflect a severe disorder. The improvement is defined by a 50% decrease of the scores from the Cambridge depersonalization scale

3 secondary outcomes

Assessment of the maintenance of therapeutic efficacy at 3 months after rTMS
Time frame: At 3 months
Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
Time frame: Baseline
Measurement of cerebral blood flow of the right angular gyrus and functional connectivity, measurement of cortical gyrification and anatomical connectivity
Time frame: Visit 3 : end of the TMS sessions (between 19 and 25 days after V2 - start of TMS)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
Background: PubMed 12239558Blanke O, Ortigue S, Landis T, Seeck M. Stimulating illusory own-body perceptions. Nature. 2002 Sep 19;419(6904):269-70. doi: 10.1038/419269a.
Background: PubMed 22805909Blanke O. Multisensory brain mechanisms of bodily self-consciousness. Nat Rev Neurosci. 2012 Jul 18;13(8):556-71. doi: 10.1038/nrn3292.
Background: PubMed 10725532Sierra M, Berrios GE. The Cambridge Depersonalization Scale: a new instrument for the measurement of depersonalization. Psychiatry Res. 2000 Mar 6;93(2):153-64. doi: 10.1016/s0165-1781(00)00100-1.
Background: PubMed 17490989Farrer C, Frey SH, Van Horn JD, Tunik E, Turk D, Inati S, Grafton ST. The angular gyrus computes action awareness representations. Cereb Cortex. 2008 Feb;18(2):254-61. doi: 10.1093/cercor/bhm050. Epub 2007 May 8.
Background: PubMed 11205340Frith CD, Blakemore SJ, Wolpert DM. Abnormalities in the awareness and control of action. Philos Trans R Soc Lond B Biol Sci. 2000 Dec 29;355(1404):1771-88. doi: 10.1098/rstb.2000.0734.
Background: PubMed 20837362Mantovani A, Simeon D, Urban N, Bulow P, Allart A, Lisanby S. Temporo-parietal junction stimulation in the treatment of depersonalization disorder. Psychiatry Res. 2011 Mar 30;186(1):138-40. doi: 10.1016/j.psychres.2010.08.022. Epub 2010 Sep 15.
Background: PubMed 12680746Sierra M, Phillips ML, Ivin G, Krystal J, David AS. A placebo-controlled, cross-over trial of lamotrigine in depersonalization disorder. J Psychopharmacol. 2003 Mar;17(1):103-5. doi: 10.1177/0269881103017001712.
Background: PubMed 16164776Sierra M, Baker D, Medford N, David AS. Unpacking the depersonalization syndrome: an exploratory factor analysis on the Cambridge Depersonalization Scale. Psychol Med. 2005 Oct;35(10):1523-32. doi: 10.1017/S0033291705005325.
Background: PubMed 18088198Sierra M. Depersonalization disorder: pharmacological approaches. Expert Rev Neurother. 2008 Jan;8(1):19-26. doi: 10.1586/14737175.8.1.19.
Background: PubMed 21087873Sierra M, David AS. Depersonalization: a selective impairment of self-awareness. Conscious Cogn. 2011 Mar;20(1):99-108. doi: 10.1016/j.concog.2010.10.018. Epub 2010 Nov 17.
Background: PubMed 11058475Simeon D, Guralnik O, Hazlett EA, Spiegel-Cohen J, Hollander E, Buchsbaum MS. Feeling unreal: a PET study of depersonalization disorder. Am J Psychiatry. 2000 Nov;157(11):1782-8. doi: 10.1176/appi.ajp.157.11.1782.
Background: PubMed 17959254Simeon D, Kozin DS, Segal K, Lerch B, Dujour R, Giesbrecht T. De-constructing depersonalization: further evidence for symptom clusters. Psychiatry Res. 2008 Jan 15;157(1-3):303-6. doi: 10.1016/j.psychres.2007.07.007. Epub 2007 Oct 23.

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.

Marion Plaze, MD, PhD principal investigator

GHU Paris Psychiatry & Neurosciences

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS in people with Depersonalization Disorder, run by Centre Hospitalier St Anne at 2 sites in France.

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 11 inclusion and 21 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 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Cambridge Depersonalization Scale (CDS) (time frame: At 3 weeks (in the end of the treatment)). 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 NCT02476435, which also lists 12 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 1 Nov 2023.