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Schizophrenia and Related DisordersPhase 3INTENSIFYNCT05603104

Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression After a First-time Treatment Failure

A Phase 3 study testing Clozapine, Esketamine Nasal Product and Escitalopram in people with Schizophrenia and Related Disorders and Major Depressive Disorder, run by Dr. Inge Winter at 1 site in Israel.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Clozapine, Esketamine Nasal Product and Escitalopram
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
1 siteIsrael
Study dates
27 Apr 2025to 24 Jun 2026
Phase
Phase 3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. In- or out patients, at least 18 years of age up until 70 (SZ study sample), 65 years (MDD study sample) and no limit for the BD study..
  • Being willing and able to provide written informed consent. Having a legal guardian to cosign is allowed. Informed consent will be signed at visit 1, before any study procedure.
  • 3. Female subjects of child bearing potential must be willing to ensure that they use effective contraception during the trial and as per the requirements in the protocol (section 8.2.1).Male subjects that will use valproate acid during the trial must use effective contraceptive measures during the trial.
  • 4. Meeting diagnostic criteria for a primary diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder (without psychotic features) or bipolar depression (bipolar disorder type I and II currently in a depressive episode), according to DSM-5. The primary diagnosis will be confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2).
  • 5. Subject experiences a treatment failure due to lack of efficacy in the current episode, as confirmed by a CGI-I ≥3; preferably this treatment is a first-line pharmacotherapeutic agent for the primary DSM-5 diagnosis, and was prescribed for at least 4 weeks within an effective dose range as specified in the Summary of Product Characteristics (SmPCs). However, other lines of treatment are accepted as well.
  • 6. Subject and clinician intend to change pharmacotherapeutic treatment. 7. A minimum symptom severity threshold needs to be present (moderate level; see below) and subject needs to experience functional impairment.
Show all 10Show fewer
  • The minimum symptom severity threshold for SZ subjects is at least 2 PANSS positive or negative items with a score of 4, or at least one PANSS positive or negative item with a score of 5.
  • The minimum symptom severity threshold for MDD is a score of ≥ 20 on the Montgomery Åsberg Depression Rating Scale (MADRS)
  • The minimum symptom severity threshold for BD is a score of ≥20 on the Montgomery Åsberg Depression Rating Scale (MADRS)
  • For all study samples: Functional impairment is defined as a score of 5 or higher on any of the three scales of the Sheehan Disability Scale (SDS).

Who cannot join

  • Being pregnant or breastfeeding.
  • Subject has failed previously on the EIPT study medication (i.e. SZ: clozapine; MDD: esketamine intranasal/(es)ketamine IV) Treatment duration as ≥ 4 weeks within an efficacious dose range according to the SmPC.
  • Subject has a known intolerance to clozapine (SZ only), esketamine intranasal/ (es)ketamine IV (MDD only) or quetiapine (BD only) or to all medication options for a study sample (related to the TAU treatment arms) or all EIPT medications (BD study sample).
  • Meeting any of the contraindications of clozapine (SZ only), esketamine intranasal/ (es)ketamine IV (MDD only) or quetiapine (BD only), or to all medication options for a study sample (related to the TAU treatment arms), or all EIPT medications (BD study sample), as specified within the applicable SmPC.
  • Subject has participated in another clinical trial in which the subject received an experimental or investigational drug or agent within 30 days before visit 1.
  • Subject experiences any other significant disease or disorder which, in the opinion of the investigator, may either put the subjects at risk because of participation in the trial, or may influence the result of the trial, or the subject's ability to participate in the trial.
Show all 15Show fewer
  • 7. Subjects with active suicidal ideation with some intent to act, without specific plan ("Yes" to question 4 of the Columbia-Suicide Severity Rating Scale (C-SSRS)) or active suicidal ideation with specific plan and intent ("Yes" to question 5 of the C-SSRS), followed by an assessment by the treating clinician who determines it is not safe for the subject to participate in the study
  • Subject meets criteria for current substance use disorder, as confirmed by the Mini International Neuropsychiatric Interview (MINI v7.0.2). Nicotine dependency is allowed, as well as mild and moderate alcohol and/or cannabis use disorder (as defined by MINI v7.0.2). Severe alcohol and/or cannabis use disorder are not allowed.
  • Subjects have not been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
  • Subjects dependent on the sponsor, investigator or trial site must be excluded from participation in advance.
  • For the SZ sample only: schizophrenia subjects cannot meet the modified Andreasen criteria for remission.
  • For the SZ sample only: Subjects that have any clinically significant abnormal values on the local laboratory test (especially ANC/WBC and liver values), electrocardiogram (ECG) or physician examinations.
  • For the BD sample only: a score of 12 or higher on the Young Mania Rating Scale (YMRS) in order to exclude subjects with predominant manic symptoms or mixed symptoms.
  • For the BD study sample only: Subjects with a history of antidepressant-induced mania or hypomania or recent rapid cycling (based on the medical file of the potential participant or the clinical judgment of the clinician).
  • For the BD study sample only: Subjects with pre-existing severe liver damage (as tested within the local laboratory test at visit 1).

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Sheba Medical Center

    Ramat Gan

Other trials in Israel

About this study

Official title: A Randomised, Controlled Trial to Investigate the Effect of an Intensified Pharmacological Treatment for Schizophrenia, Major Depressive Disorder and Bipolar Depression in Subjects Who Had a First-time Treatment Failure on Their First-line Treatment.

Schizophrenia, bipolar and major depressive disorders collectively affect over 10 million people across the EU and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers or antipsychotics. It is unknown whether this first-line treatment will be successful. After this first-line treatment fails, usually a second-line treatment is initiated, and when this is not successful either a third-line treatment is initiated. Third-line treatments are quite successful, especially when compared to second-line treatments. The research question is whether the third-line treatments (early-intensified treatments) when used earlier in the disease course for schizophrenia, bipolar and major depressive disorders. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs.

Read the detailed description

Rationale Schizophrenia (SZ), bipolar depression (BD) and major depressive disorders (MDD) collectively affect over 10 million people across the European Union (EU) and are associated with annual healthcare and societal costs in excess of 100 billion Euros. When diagnosed with one of these disorders, patients are prescribed psychotropic medication such as antidepressants, mood stabilisers and/or antipsychotics. The effectiveness of these treatments for individual patients cannot be predicted. After this first-line treatment fails, usually a second-line treatment is initiated; when this is not effective either, a third-line treatment is initiated. Third-line treatments are quite effective, for people not responding to the first two treatments lines. However, they are used late in the disease course and clear evidence from direct comparisons of treatment algorithms is lacking. The research question is whether the third-line treatments would be more efficacious than the current second-line treatments (treatment as usual) for schizophrenia, bipolar and major depressive disorders. Third-line treatment can then be regarded as 'early-intensified'. If this is indeed the case, this could lead to the prevention of unnecessary trials of ineffective treatments and recommendations for adaptations of worldwide guidelines as well as a reduction of healthcare and societal costs. Additionally, The INTENSIFY trial is part of the larger Horizon 2021 project, with the central goal of paving the way for a shift towards a treatment decision-making process tailored for the individual at risk for treatment resistance. To that end, we aim to establish evidence-based criteria to make decisions of early intense treatment in individuals at risk for treatment resistance across the major psychiatric disorders of schizophrenia, bipolar disorder and major depression.

Objective The primary objective is to compare the treatment response, expressed as change in symptom severity as measured through the Positive And Negative Syndrome Scale (PANSS; SZ sample), and the Montgomery-Åsberg Depression Rating Scale (MADRS; MDD/BD samples) under an early-intensified pharmacological treatment to that under treatment as usual, in subjects who had a first-time treatment failure on their first-line treatment.

Main trial endpoints Change in symptom severity total score from baseline (visit 2) to end of treatment (visit 4). For SZ, this is measured using PANSS. For MDD and BD, MADRS is applied.

Secondary trial endpoints

  1. All study samples: to compare changes in the severity and improvement sub-scores of the Clinical Global Impression Scale (CGI) between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  2. All study samples: to compare changes in the levels of depression and anxiety as assessed with the Hospital Anxiety and Depression Scale (HADS) between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  3. All study samples: to compare changes in cognitive performance as measured through the Trail Making Test, Digit Symbol Substitution Test, Rey Auditory Verbal Learning Test as well as the Perceived Deficits Questionnaire between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  4. All study samples: to compare changes in quality of life and functioning measures (Q-LES-Q-SF, LAPS, QLS-100 and SDS between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  5. All study samples: to compare presence of side effects as measured through General Assessment of Side Effects Scale (GASE) and reported spontaneously between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  6. All study samples: to compare use of concomitant medication between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  7. All study samples: to compare premature discontinuation (timing and reason)between the two treatment arms over the six week treatment period (visit 2 versus visit 4).
  8. All study samples: comparison of the proportion of participants (EIPT vs. TAU) that is remission at visit 4. For SZ, remission is defined as meeting the PANSS modified Andreasen criteria (Low scores (≤3) P1. Delusions; P3. Hallucinatory behavior; P2. Conceptual disorganization; N1. Blunted affect; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity and flow of conversation; G5. Mannerisms/posturing; G9. Unusual thought content. For MDD/BD, remission is defined as a MADRS score ≤ 12
  9. To compare changes in suicidal ideation between treatment arms.
  10. SZ sample: to compare changes in PANSS subscale scores between the two treatment arms over the six-week treatment period (visit 2 versus visit 4).
  11. BD study sample: To compare occurrence of (hypo)manic episode during the study between the treatment arms

Trial design The clinical study is an international, multicenter controlled, randomised, open label trial, with a treatment duration of 6 weeks.

Trial population The aim is to recruit 418 subjects into each of the study samples, leading to a total sample size of 1254 subjects. The study samples are: schizophrenia (schizophrenia, schizoaffective disorder or schizophreniform disorder), major depressive disorder and bipolar depressive disorder (bipolar I or II disorder currently in a depressive episode). Male and female subjects, in- and out-patients, within the age of at least 18 years old are eligible for participation. The main exclusion criteria to protect the subjects are subjects being pregnant or breastfeeding, subjects with previous failure on the early-intensified pharmacological treatments, known intolerance to any of the treatments or meeting any contraindications for the early-intensified pharmacological treatments.

Interventions

Per study sample (SZ, MDD, BD), subjects are randomised to treatment as usual (second-line treatment) or to the early-intensified pharmacological treatment (third-line treatment). Treatment per group per study sample can be found below:

SZ sample:

Treatment as Usual (TAU): Switch to second line antipsychotic Early-Intensified Pharmacological Treatment (EIPT): Switch to clozapine

MDD sample:

Treatment as Usual (TAU): Switch to second-line antidepressant Early-Intensified Pharmacological Treatment (EIPT): Oral antidepressant plus esketamine nasal spray or esketamine IV or ketamine IV

BD sample:

Treatment as Usual (TAU): Switch to quetiapine plus lithium or valproate acid

Early-Intensified Pharmacological Treatment (EIPT): Switch to:

  1. one of the following: escitalopram, sertraline, bupropion or venlafaxine plus
  2. two of the following: lithium, valproate acid or quetiapine

Ethical considerations relating to the clinical trial including the expected benefit to the individual subject or group of subjects represented by the trial subjects as well as the nature and extent of burden and risks All medications studied in the current trial are widely used (alone or in combination) in clinical practice and the risks for side effects are well established. In the current study, clinical practice is mimicked as much as possible to maximize generalizability and for feasibility purposes. To this end, Summaries of Product Characteristics (SmPCs) are followed with regards to contraindications (implemented as exclusion criterion), safety measures and allowed combinations with other medications. Site visits and assessments are kept to a minimum to keep subject burden at an acceptable level, while meeting the objectives of the study. Blood samples are only collected when subjects provide consent; safety measures are performed as part of clinical routine.

Overall, the risks are similar to daily clinical practice; the only difference relative to clinical practice is the application of early-intensified pharmacological treatment earlier in the illness. However, these intense treatment options are also commonly prescribed by clinicians. There are no indications in existing literature that the earlier introduction of these medications poses a safety risk.

A benefit of the study is that if it indeed turns out that the early-intensified pharmacological treatment is associated with more symptom improvement compared to treatment as usual, treatment guidelines may be changed accordingly and early-intensified pharmacological treatment becomes available earlier in the illness course, as second-line treatment. This would mean that future subjects have to go through less trial and error, which results in a reduced burden for subjects as well as lower societal and healthcare costs.

IMPORTANT: the study was submitted to the European suthorities and they requested to split this study into 3 studies (1 for each diagnostic category). We have done this and created 3 new ClinicalTrials.gov studies as well. The numbers are NCT05958875 (SZ substudy), NCT05973786 (BD substudy) and NCT05973851 (MDD substudy).

The site in the UK (London) followed the advice and will submit 3 separate protocols. However, Israel already submitted this as one protocol. Therefore, we keep this clinicaltrials.gov number for Israel.

Being tested
Clozapine, Esketamine Nasal Product, Escitalopram, Sertraline, Venlafaxine
Medical subject headings
Schizophrenia, Depressive Disorder, Major, Bipolar Disorder

What participants receive

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

  • ClozapineDrug

    Also called ATC code: N05AH02

    See arm description

  • Esketamine Nasal ProductDrug

    Also called ATC code: N06AB10

    See arm description

  • EscitalopramDrug

    Also called ATC code: N06AB10

    See arm description

  • SertralineDrug

    Also called ATC code: N06AB06

    See arm description

  • VenlafaxineDrug

    Also called ATC code: N06AX16

    See arm description

  • LithiumDrug

    Also called ATC code: N05AN01

    See arm description

  • Valproate acidDrug

    Also called ATC code: N03AG01

    See arm description

  • QuetiapineDrug

    Also called ATC code: N05AH04

    See arm description

  • Second-line AntidepressantsDrug

    See arm description

  • Second-line AntipsychoticsDrug

    See arm description

  • Ketamine HydrochlorideDrug

    Also called N01AX03

    See arm description

  • Esketamine hydrochlorideDrug

    Also called N015X14

    See arm description

  • BupropionDrug

    Also called ATC code: N06AX12

    See arm description

Study groups in NCT05603104
Study groupRoleWhat they receive
Schizophrenia EIPT: Switch to clozapineExperimentalSchizophrenia randomized to EIPT: Switch to clozapine. Brand, dosage, frequency and duration up to the investigator's discretion
Receives: Drug: Clozapine
Schizophrenia TAU: second-line antispychoticActive comparatorSchizophrenia randomized to TAU: switch to second-line antispychotic. Compound, brand, dosage, frequency and duration up to the investigator's discretion (in accordance with SmPC)
Receives: Drug: Second-line Antipsychotics
Major Depressive Disorder EIPT: second-line antidepressant + esketamine nasal sprayExperimentalMajor depressive disorder randomized to EIPT: Switch to second-line antidepressant + esketamine nasal spray or (es)ketamine infusion. Antidepressant: Compound, brand, dosage, frequency and duration up to the investigator's discretion (in accordance with SmPC). Esketamine nasal spray: 2 times per week for 4 weeks. Initial dose 28 mg, after that increases can be made with 28 mg per increase (up to 84 mg per week). This decision is up to the investigator's discretion (in accordance with SmPC). (Es)ketamine infusion: performed twice weekly for 4 weeks. Compound, brand up to the investigator's discretion (in accordance with SmPC).
Receives: Drug: Esketamine Nasal Product; Drug: Second-line Antidepressants; Drug: Ketamine Hydrochloride; Drug: Esketamine hydrochloride
Major Depressive Disorder TAU: second-line antidepressantActive comparatorMajor depressive disorder randomized to TAU: Switch to second-line antidepressant + esketamine nasal spray or ketamine IV or esketamine IV . Antidepressant: Compound, brand, dosage, frequency and duration up to the investigator's discretion (in accordance with SmPC).
Receives: Drug: Second-line Antidepressants
Bipolar Depression EIPT: Switch to one of the following combinations:ExperimentalBipolar Depression randomized to EIPT: Switch to 1. one of the following: escitalopram, sertraline, bupropion or venlafaxine plus 2. two of the following: lithium, valproate acid or quetiapine
Receives: Drug: Escitalopram; Drug: Sertraline; Drug: Venlafaxine; Drug: Lithium; Drug: Valproate acid; Drug: Quetiapine; Drug: Bupropion
Bipolar Depression TAU: Switch to quetiapine plus lithium or valproate acid or lamotrigineActive comparatorBipolar Depression randomized to TAU: Switch to quetiapine plus lithium or valproate acid Compound, brand, dosage, frequency and duration up to the investigator's discretion (in accordance with SmPC).
Receives: Drug: Lithium; Drug: Valproate acid; Drug: Quetiapine

What is being measured

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

  1. Change in symptom severity

    Change in symptom severity total score from baseline (visit 2) to end of treatment (visit 4). For Schizophrenia, this is measured using the Positive And Negative Syndrome Scale. For Major Depressive Disorder and Bipolar Depression, Montgomery Åsberg Depression Rating Scale is applied.

    Measured: 6 weeks

Secondary outcomes (17)

  1. All study samples: to compare changes in the severity and improvement

    All study samples: to compare changes in the severity and improvement sub-scores of the Clinical Global Impression Scale between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  2. All study samples: to compare changes in the levels of depression and anxiety

    All study samples: to compare changes in the levels of depression and anxiety as assessed with the Hospital Anxiety and Depression Scale bbetween the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  3. All study samples: to compare changes in cognitive performance #1

    All study samples: to compare changes in cognitive performance as measured through the Trail Making Test between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  4. All study samples: to compare changes in cognitive performance #2

    All study samples: to compare changes in cognitive performance as measured through the Digit Symbol Substitution Test between the two treatment arms over four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  5. All study samples: to compare changes in cognitive performance #3

    All study samples: to compare changes in cognitive performance as measured through the Rey Auditory Verbal Learning Test between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  6. All study samples: to compare changes in cognitive performance #4

    All study samples: to compare changes in cognitive performance as measured through the Perceived Deficits Questionnaire between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  7. All study samples: to compare changes in functioning measure #1

    All study samples: to compare changes in functioning measure (Leuven Afective and Pleasure Scale) between the two treatment arms over the four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  8. All study samples: to compare changes in functioning measure #2

    All study samples: to compare changes in functioning measure (Sheehan Disability Scale) between the two treatment arms over the four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  9. All study samples: to compare changes in quality of life #1

    All study samples: to compare changes in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire Short Form) between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  10. All study samples: to compare changes in quality of life #2

    All study samples: to compare changes in quality of life and functioning measures (Quality of Life Scale -100, subscale inner tension) between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  11. All study samples: to compare presence of side effects

    All study samples: to compare presence of side effects as measured through General Assessment of Side Effect Scale between the two treatment arms over the two treatment arms over the four weeks (Major Depressive Disorder Group)/six weeks (Schizophrenia/Bipolar Depression groups) treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  12. All study samples: to compare use of concomitant medication

    All study samples: to compare use of concomitant medication between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  13. All study samples: to compare premature treatment discontinuation

    All study samples: to compare premature treatment discontinuation (timing and reason) between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  14. Schizophrenia sample: to compare changes in Positive and Negative syndrome subscale scores

    Schizophrenia sample: to compare changes in Positive and Negative syndrome subscale scores between the two treatment arms over the six weeks treatment period (visit 2 versus visit 4).

    Measured: 6 weeks

  15. All study samples: comparison of the proportion of participants (EIPT vs. TAU) that is remission at visit 4.

    For SZ, remission is defined as meeting the PANSS modified Andreasen criteria (Low scores (≤3) P1. Delusions; P3. Hallucinatory behavior; P2. Conceptual disorganization; N1. Blunted affect; N4. Passive/apathetic social withdrawal; N6. Lack of spontaneity and flow of conversation; G5. Mannerisms/posturing; G9. Unusual thought content. For MDD/BD, remission is defined as a MADRS score ≤ 12

    Measured: 6 weeks

  16. All study samples: To compare changes in suicidal ideation between treatment arms.

    Changes on the Columbia-Suicide Severity Rating Scale (C-SSRS) throughout the study; EIPT vs TAU. Higher scores means higher suicidal ideation. The maximum score is 5.

    Measured: 6 weeks

  17. BD study sample: To compare occurrence of (hypo)manic episode during the study between the treatment arms using the Young Mania Rating Scale

    Occurrence of (hypo)manic episodes throughout the study (including V5); EIPT vs TAU. Scores of 12 or higher means that a participant is in a (hypo)manic episode of bipolar disorder.

    The minimum score on the YMRS is 0 and the maximum score 60.

    Measured: 6 weeks.

Timeline

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

  1. First posted2 Nov 2022
  2. Study start27 Apr 2025
  3. Primary completion24 Jun 2026
  4. Study completion24 Jun 2026

Why it stopped: The site in Israel stopped recruitment due to logistic reasons. Other sites are recruiting for 2023-506602-39-00, 2023-506605-19-00, 2023-506617-21-00.

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel randomization to the treatment as usual (TAU) or early-intensified pharmacological treatment (EIPT) group for each of the study groups (schizophrenia, major depressive disorder, bipolar depression) leading to 6 arms.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05603104
Sponsor's protocol ID
2022-502185-24-00 (EU CT #)
Acronym
INTENSIFY
Status last verified
Nov 2026
First submitted
13 Oct 2022
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Swieczkowski D, Kwasny A, Cubala WJ. Cross-sectional analysis of ongoing clinical trials involving lamotrigine for mental disorders: Insights from ClinicalTrials.gov and the EU clinical trials. Psychiatry Res. 2026 Feb;356:116878. doi: 10.1016/j.psychres.2025.116878. Epub 2025 Dec 4.

    PubMed 41401709

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Clozapine, Esketamine Nasal Product and Escitalopram in people with Schizophrenia and Related Disorders and Major Depressive Disorder, run by Dr. Inge Winter at 1 site in Israel.

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 10 inclusion and 15 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: stopped early, as of the sponsor's last update on 5 Nov 2026. 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 Israel. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The site in Israel stopped recruitment due to logistic reasons. Other sites are recruiting for 2023-506602-39-00, 2023-506605-19-00, 2023-506617-21-00.). 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 symptom severity (time frame: 6 weeks). 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 NCT05603104, 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 5 Nov 2026.

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