SchizophreniaNCT04278027
Cognitive Remediation Therapy in Schizophrenia: Effects on Epigenetics
A study testing Cognitive Remediation Therapy in people with Schizophrenia, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Cognitive Remediation Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 3 Jan 2017to 15 Jun 2020
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia according to DSM-5 and confirmed by the semi-structured interview (SCID) for the axis 1.
- Presence of cognitive impairment confirmed by the neuropsychological battery
- Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment .
Who cannot join
- Presence of organic-cerebral affectation due to neurological or traumatic conditions
- Antipsychotic dose change >10%
- Abuse of psychotropic substances
- Presence of other psychiatric symptomatology
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Epigenetic Regulation of Brain-Derived Neurotrophic Factor (BDNF) Gene Expression According to Response to Cognitive Remediation in Schizophrenia
This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia.
Read the detailed description
OBJECTIVES: To investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene. It also aims to test whether BDNF valine-66-methionine (Val66Met) polymorphism influences CRT treatment outcome among people with schizophrenia.
SAMPLE AND METHODS: A randomized and controlled study will be carried out with two groups: patients receiving CRT and patients in control condition without any cognitive intervention and receiving Treatment as Usual (TAU). Methylation levels of BDNF gene at different sites will be contrasted before and after treatment. Additionally, neurocognition profile, level of symptoms and psychosocial functioning will also be tested. CRT outcomes will be investigated in a mixed model for repeated measures.
- Conditions
- Schizophrenia
- Being tested
- Cognitive Remediation Therapy
- Keywords
- Cognitive Remediation, Epigenetics, BDNF
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Remediation TherapyBehavioural
Also called CIRCuiTS
"CIRCuiTS is a web-based computerised CR therapy, delivered by a therapist but supplemented with independent sessions to facilitate massed practice. It targets metacognition, particularly strategy use, in addition to providing massed practice of basic cognitive functions. The therapist facilitates motivation, metacognitive and strategy development and generalisation of learning by encouraging the participant to learn about and regulate their cognitive performance and to transfer this learning to meet real-world goals. Therapists provide additional scaffolding for CR tasks to ensure consistent successful performance. Independent sessions involve carrying out cognitive tasks allocated by the therapist to ensure scaffolded learning" (Reeder et al.2017)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | Cognitive Remediation Therapy. CRT will be based on CIRCuiTS, a computerized program. Receives: Behavioral: Cognitive Remediation Therapy |
| Treatment as usual | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in methylation at Cytosine-phosphate-Guanine (CpG) exon
Mean methylation percentage in CpG island BDNF CpG exon I: located at chr11:27743473-27744564 in the BDNF
Measured: Baseline and after 4 months
Change in methylation at CpG exon IV
Mean methylation percentage of CpG region BDNF CpG exon IV: located at chr11:27723060-27723294 in exon IV, upstream of the start codon in exon VII
Measured: Baseline and after 4 months
Secondary outcomes (2)
Change in cognition
Total score in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery
Measured: Baseline and after 4 months
Change in Symptoms
Total score in Positive and Negative Syndromes Scale (PANSS)
Measured: Baseline and after 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start3 Jan 2017
- Primary completion5 May 2020 (estimated)
- Study completion15 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe 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
- Model description
- Study Procedure. 60 patients with schizophrenia disorder (according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) classification, determined by The Structured Clinical Interview for DSM-5 (SCID-5) interview will be recruited and randomly allocated in one of the two groups: CRT or treatment as usual control group. All participants will undergo neurocognitive testing over a 2-week period, followed by a blood draw. After random allocation, 40 participants will follow a computerized cognitive remediation program and 20 will be followed a similar period of time without any cognitive intervention. Subjects will have another blood sample drawn after completion of the cognitive therapy or the TAU. All subjects should remain on stable doses of medications while in the study (no dose change \> 10%). Finally, subjects will be reassessed on PANSS and cognitive measures and social functioning by personnel blind to group assignment.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Rafael Penades, Hospital Clinic of Barcelona
- Investigators
- Rafael Penadés, PhD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278027
- Sponsor's protocol ID
- 24618
- Other IDs
- PI17/00872
- Status last verified
- Feb 2020
- First submitted
- 17 Feb 2020
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Penades R, Almodovar-Paya C, Garcia-Rizo C, Ruiz V, Catalan R, Valero S, Wykes T, Fatjo-Vilas M, Arias B. Changes in BDNF methylation patterns after cognitive remediation therapy in schizophrenia: A randomized and controlled trial. J Psychiatr Res. 2024 May;173:166-174. doi: 10.1016/j.jpsychires.2024.03.014. Epub 2024 Mar 23.
PubMed 38537483
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epigenetic Regulation of Brain-Derived Neurotrophic Factor (BDNF) Gene Expression According to Response to Cognitive Remediation in Schizophrenia
- ClinicalTrials.gov ID
- NCT04278027
- Acronym / sponsor ID
- 24618
- Conditions
- Schizophrenia
- Keywords
- Cognitive Remediation, Epigenetics, BDNF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Collaborators
- National Alliance for Research on Schizophrenia and Depression, Instituto de Salud Carlos III
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 5 May 2020 (estimated)
- Study completion
- 15 Jun 2020 (estimated)
- First posted
- 20 Feb 2020 (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.
This study is a randomised and controlled trial that aims to investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene in patients with Schizophrenia.
Detailed description
OBJECTIVES: To investigate whether Cognitive Remediation Therapy (CRT) can modulate epigenetic mechanisms by changing methylation levels of BDNF gene. It also aims to test whether BDNF valine-66-methionine (Val66Met) polymorphism influences CRT treatment outcome among people with schizophrenia.
SAMPLE AND METHODS: A randomized and controlled study will be carried out with two groups: patients receiving CRT and patients in control condition without any cognitive intervention and receiving Treatment as Usual (TAU). Methylation levels of BDNF gene at different sites will be contrasted before and after treatment. Additionally, neurocognition profile, level of symptoms and psychosocial functioning will also be tested. CRT outcomes will be investigated in a mixed model for repeated measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Study Procedure. 60 patients with schizophrenia disorder (according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) classification, determined by The Structured Clinical Interview for DSM-5 (SCID-5) interview will be recruited and randomly allocated in one of the two groups: CRT or treatment as usual control group. All participants will undergo neurocognitive testing over a 2-week period, followed by a blood draw. After random allocation, 40 participants will follow a computerized cognitive remediation program and 20 will be followed a similar period of time without any cognitive intervention. Subjects will have another blood sample drawn after completion of the cognitive therapy or the TAU. All subjects should remain on stable doses of medications while in the study (no dose change > 10%). Finally, subjects will be reassessed on PANSS and cognitive measures and social functioning by personnel blind to group assignment.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Remediation Therapy | Experimental | Behavioral: Cognitive Remediation TherapyCognitive Remediation Therapy. CRT will be based on CIRCuiTS, a computerized program. |
| Treatment as usual | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of schizophrenia according to DSM-5 and confirmed by the semi-structured interview (SCID) for the axis 1.
- Presence of cognitive impairment confirmed by the neuropsychological battery
- Stable symptomatology at least during the last six months and the estimation of not modifying pharmacological antipsychotic treatment .
Key exclusion criteria (4 listed)
- Presence of organic-cerebral affectation due to neurological or traumatic conditions
- Antipsychotic dose change >10%
- Abuse of psychotropic substances
- Presence of other psychiatric symptomatology
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 |
|---|---|---|
| Cognitive Remediation TherapyAlso: CIRCuiTS"CIRCuiTS is a web-based computerised CR therapy, delivered by a therapist but supplemented with independent sessions to facilitate massed practice. It targets metacognition, particularly strategy use, in addition to providing massed practice of basic cognitive functions. The therapist facilitates motivation, metacognitive and strategy development and generalisation of learning by encouraging the participant to learn about and regulate their cognitive performance and to transfer this learning to meet real-world goals. Therapists provide additional scaffolding for CR tasks to ensure consistent successful performance. Independent sessions involve carrying out cognitive tasks allocated by the therapist to ensure scaffolded learning" (Reeder et al.2017) | Behavioural | Cognitive Remediation Therapy |
Primary outcome
Change in methylation at Cytosine-phosphate-Guanine (CpG) exon
Time frame: Baseline and after 4 months
Mean methylation percentage in CpG island BDNF CpG exon I: located at chr11:27743473-27744564 in the BDNF
Change in methylation at CpG exon IV
Time frame: Baseline and after 4 months
Mean methylation percentage of CpG region BDNF CpG exon IV: located at chr11:27723060-27723294 in exon IV, upstream of the start codon in exon VII
2 secondary outcomes
Change in cognition
Time frame: Baseline and after 4 months
Change in Symptoms
Time frame: Baseline and after 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Derived from this study: PubMed 38537483Penades R, Almodovar-Paya C, Garcia-Rizo C, Ruiz V, Catalan R, Valero S, Wykes T, Fatjo-Vilas M, Arias B. Changes in BDNF methylation patterns after cognitive remediation therapy in schizophrenia: A randomized and controlled trial. J Psychiatr Res. 2024 May;173:166-174. doi: 10.1016/j.jpsychires.2024.03.014. Epub 2024 Mar 23.
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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.
Rafael Penadés, PhD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Remediation Therapy in people with Schizophrenia, run by Hospital Clinic of Barcelona at 1 site in Spain.
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 4 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 20 Feb 2020. 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 Spain. 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?
Change in methylation at Cytosine-phosphate-Guanine (CpG) exon (time frame: Baseline and after 4 months). The study lists 2 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 NCT04278027, 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 20 Feb 2020.