Prodromal SchizophreniaPhase 3ESPRIT-B1NCT03149107
"Multimodal Prevention of Psychosis - Investigating Efficacy of N-Acetylcysteine and Psychotherapy in CHR-Patients"
A Phase 3 study testing N-Acetylcysteine, IPPI (Integrated Preventive Psychological Intervention) and PSM (Psychological stress management) in people with Prodromal Schizophrenia, run by University Hospital, Bonn at 10 sites in Germany.
Trial summary
Schizophrenia is a severe mental disorder associated with significant impairments in affective, cognitive and social functioning. Consequently, a special interest in the prevention of schizophrenia and psychotic disorders has emerged. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Prodromal Schizophrenia
- What is being tested?
- N-Acetylcysteine, IPPI (Integrated Preventive Psychological Intervention) and PSM (Psychological stress management)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 10 sitesGermany
- Study dates
- 1 Sep 2016to Jan 2021
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 40 years;
- Subjects with the ability to follow study instructions and likely to attend and complete all required visits;
- Written informed consent of the subject;
- Subjects are able to speak, write and understand the German language sufficiently well (at the investigators discretion) to complete all required study procedures;
- Specific inclusion criterion:
- Clinical High Risk Criteria : ESPRIT Ultra-high risk criteria (Attenuated Positive Symptoms and/or Brief Llimited Intermittend Psychotic Symptoms and/or a combination of familial risk or schizotypal disorder with a significant loss of functioning; severity assessed by the Structured Interview for Prodromal Syndromes, SIPS 5.0) and/or The Basic Symptom Criterion 'Cognitive Disturbances, COGDIS' (2/9 cognitive-perceptive basic symptoms; assessed by the Schizophrenia Proneness Instrument - Adult Version, SPI-A)
Who cannot join
- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure;
- Simultaneously participation in another clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning. The simultaneous participation in a noninterventional clinical trial is permitted in case the subject is nevertheless able and willing to attend and complete all required visits and in case there are no other contraindications;
- Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at other clinically significant risks than those that are defined as outcome of this study (development of a first psychotic episode, functional deterioration), may confound the trial results, or may interfere with the subject's per protocol participation in this clinical trial;
- Acute Suicidality;
- Known substance abuse or dependence according to DSM-IV-TR;
- Patients with hepatic or renal failure, or with known problems of galactose intolerance, clinically significant lactase deficiency or glucose-galactose malabsorption or histamine-intolerance;
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- Subjects with known asthma bronchiale;
- Subjects with a history of gastrointestinal ulcer;
- Intake of antitussives (cough-relieving agents);
- Intake of nitroglycerin
- Exclusion criteria regarding special restrictions for females: Current pregnancy or pregnancy planned within 9 months after start of medication or nursing women and
- Females of childbearing potential, who are not using and not willing to use medically reliable methods of contraception for the entire study duration (such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) unless they are surgically sterilized / hysterectomized or there are any other criteria considered sufficiently reliable by the investigator in individual cases.
- Indication specific exclusion criteria:
- Having had a psychotic episode for > 1 week (according to SIPS 5.0);
- Having symptoms relevant for inclusion potentially arising from a known general medical disorder;
- Life time antipsychotic medication for more than 30 days (cumulative number of days) at or above minimum dosage of the '1st episode psychosis' range of DGPPN S3 Guidelines (Exception: maximum dosage for aripiprazole 5 mg/d) (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde, 2006);
- Any intake of antipsychotic medication (i.e., independent of duration of intake) within the past 3 months before psychopathological baseline assessments (including self-ratings and screening assessments) at or above minimum dosage of the '1st episode psychosis' range of DGPPN S3 Guidelines (Exception: maximum dosage for aripiprazole 5 mg/d) (Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde, 2006);
- Any intake of mood stabilizers (lithium, valproate, carbamazepine, oxcabazepine, lamotrigine) > 30 days (cumulative number of days) during the past three months or any intake during the month before psychopathological baseline assessments;
- Intake of antidepressants during the past 30 days before psychopathological baseline assessments;
- Intake of benzodiazepines for more than 2 consecutive days during the past 5 days before psychopathological baseline assessments;
- Psychotherapeutic intervention during the past 30 days before psychopathological baseline assessments;
- Any past psychotherapeutic treatment targeting specifically psychotic symptoms or its prevention.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Germany10 sites
Uniklinik Aachen
Aachen, North Rhine-Westphalia, 52074
Rheinhessen Fachklinik Alzey
Alzey, Rhineland-Palatinate, 55232
Charité Berlin
Berlin, 10117
Berlin Vivantes
Berlin, 10967
Uniklinikum Bonn
Bonn, North Rhine-Westphalia, 53127
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
LVR Klinik Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
Zentralinstitut für Gesundheit Mannheim
Mannheim, Baden-Wurttemberg, 68159
LMU Klinikum München
München, Bavaria, 80336
Universitätsklinik Tübingen
Tübingen, Baden-Wurttemberg, 72076
About this study
Official title: Multimodal Prevention of First Psychotic Episode - a 2x2-Factorial Randomized Trial Investigating the Efficacy of Acetylcysteine and Integrated Preventive Psychological Intervention in Subjects Clinically at High Risk for Psychosis
Schizophrenia is a severe mental disorder associated with significant impairments in affective, cognitive and social functioning. Consequently, a special interest in the prevention of schizophrenia and psychotic disorders has emerged. Pharmacological as well as psychological interventions show promising preventive effects. The purpose of this multicentric study is the investigation of possible preventive effects of a treatment combination containing a psychotherapy form and medication (N-Acetylcytein - NAC) in individuals with an enhanced risk for developing schizophrenia. Both treatment forms may reduce the risk in this population due to their specific properties: The psychotherapy can improve social skills, whereas NAC is supposed to develop its protective effects on neuronal level due to its antiinflammatory properties. The investigators will examine the preventive effects by measuring transition rates to psychosis after treatment as well as improvements in social, affective and cognitive functioning.
Read the detailed description
Psychotic disorders are among the most expensive brain-related disorders in Europe. This is mainly due to their onset early in life and their long-term disabling courses. Current treatments fail to improve most influential factors such as social-cognitive deficits. Prevention is recognized as one of the key strategies to fight these deteriorating outcomes and is expected to significantly reduce both, the societal costs as well as the immense burden for the patients and for their families. Recent meta-analyses indicate promising preventive effects of both pharmacological and cognitive-behavioural interventions. Yet, reported transition rates are still too high. Clinical evidence suggests that disturbances of social functioning predict conversion to psychosis. Neurobiological evidence implicates glutamatergic dysfunction and redox imbalance in the pathophysiology of schizophrenia. The investigators hypothesize that interventions targeting (i) social functioning and (ii) glutamatergic / oxidative pathways already in at-risk states would significantly reduce transition rates. To test these hypotheses, our study is designed as a randomized, placebo-controlled, 18-month trial (six months of intervention plus 12 months of follow-up), involving 200 subjects at-risk for psychosis. Specifically, the investigators will compare the preventive effects of a cognitive-behavioural and social-cognitive intervention to a pharmacological intervention (IPPI) with Acetylcysteine, a drug with a proglutamatergic, neuroprotective and anti-inflammatory profile in a 2x2 factorial design. The results of our planned study are expected to provide new and well tolerated interventions, thus hopefully helping to achieve the major goal of individualized prevention, and, consequently, lower the individual and societal burden of psychosis.
- Conditions
- Prodromal Schizophrenia
- Being tested
- N-Acetylcysteine, Placebo, IPPI (Integrated Preventive Psychological Intervention), PSM (Psychological stress management)
- Keywords
- Prodrome, CHR, Schizophrenia, prevention, N-acetylcysteine
- Medical subject headings
- Schizotypal Personality Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-AcetylcysteineDrug
Also called NAC
N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention (IPPI or PSM).
PlaceboDrug
Will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM).
IPPI (Integrated Preventive Psychological Intervention)Behavioural
IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater)
PSM (Psychological stress management)Behavioural
PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater).
| Study group | Role | What they receive |
|---|---|---|
| IPPI + NAC | Experimental | IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater).
N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention. Double-blinded. Receives: Drug: N-Acetylcysteine; Behavioral: IPPI (Integrated Preventive Psychological Intervention) |
| PSM + NAC | Experimental | PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater).
N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention. Double-blinded. Receives: Drug: N-Acetylcysteine; Behavioral: PSM (Psychological stress management) |
| IPPI + Placebo | Experimental | IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater).
Placebo will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM). Receives: Drug: Placebo; Behavioral: IPPI (Integrated Preventive Psychological Intervention) |
| PSM + Placebo | Active comparator | PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater).
N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Placebo will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM). Receives: Drug: Placebo; Behavioral: PSM (Psychological stress management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transition to psychosis
Transition to psychosis within 18 months, defined (according to EPOS1) as the presence of at least one psychotic symptom for at least one week (assessed by the SIPS).
Measured: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Psychosocial functioning
Psychosocial functioning assessed by the SOFAS and the FROGS
Measured: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Secondary outcomes (4)
Symptom remission
- Remission of symptomatic clinical high risk (CHR) criteria (APS/BLIPS and/or COGIDS); decrease of positive, negative and disorganization symptoms (assessed by the SIPS, BNSS score); conceptual disorganization and cognitive basic symptoms (COGDIS, SPI-A); as well as at-risk symptoms according to UHR (SPI-A);
Measured: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Depression remission
Remission of depressive symptoms (measured by CDSS)
Measured: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Improvement of social cognition
Improvement of social cognition (measured by SAT-MC I \& II, PoFA)
Measured: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Assessment of safety and tolerability
Neurologic and general examination (medical history, weight, - adverse events (assessed by UKU SYMPTOM-LIST), Laboratory assessments
Measured: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start1 Sep 2016
- Primary completionJan 2021
- Study completionJan 2021
Why it stopped: Recruitment not sufficient
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prodromal SchizophreniaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cologne, Central Institute of Mental Health, Mannheim, Ludwig-Maximilians - University of Munich, University Hospital Tuebingen, Heinrich-Heine University, Duesseldorf, Charite University, Berlin, Germany, RWTH Aachen University
- Responsible party
- Principal investigator, Rene Hurlemann, University Hospital, Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03149107
- Sponsor's protocol ID
- University Hospital, Bonn
- Acronym
- ESPRIT-B1
- Status last verified
- May 2022
- First submitted
- 8 May 2017
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Prevention of First Psychotic Episode - a 2x2-Factorial Randomized Trial Investigating the Efficacy of Acetylcysteine and Integrated Preventive Psychological Intervention in Subjects Clinically at High Risk for Psychosis
- ClinicalTrials.gov ID
- NCT03149107
- Acronym / sponsor ID
- ESPRIT-B1 / University Hospital, Bonn
- Conditions
- Prodromal Schizophrenia
- Keywords
- Prodrome, CHR, Schizophrenia, prevention, N-acetylcysteine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment not sufficient
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Collaborators
- University of Cologne, Central Institute of Mental Health, Mannheim, Ludwig-Maximilians - University of Munich, University Hospital Tuebingen, Heinrich-Heine University, Duesseldorf, Charite University, Berlin, Germany, RWTH Aachen University
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 11 May 2017 (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.
Schizophrenia is a severe mental disorder associated with significant impairments in affective, cognitive and social functioning. Consequently, a special interest in the prevention of schizophrenia and psychotic disorders has emerged. Pharmacological as well as psychological interventions show promising preventive effects. The purpose of this multicentric study is the investigation of possible preventive effects of a treatment combination containing a psychotherapy form and medication (N-Acetylcytein - NAC) in individuals with an enhanced risk for developing schizophrenia. Both treatment forms may reduce the risk in this population due to their specific properties: The psychotherapy can improve social skills, whereas NAC is supposed to develop its protective effects on neuronal level due to its antiinflammatory properties. The investigators will examine the preventive effects by measuring transition rates to psychosis after treatment as well as improvements in social, affective and cognitive functioning.
Detailed description
Psychotic disorders are among the most expensive brain-related disorders in Europe. This is mainly due to their onset early in life and their long-term disabling courses. Current treatments fail to improve most influential factors such as social-cognitive deficits. Prevention is recognized as one of the key strategies to fight these deteriorating outcomes and is expected to significantly reduce both, the societal costs as well as the immense burden for the patients and for their families. Recent meta-analyses indicate promising preventive effects of both pharmacological and cognitive-behavioural interventions. Yet, reported transition rates are still too high. Clinical evidence suggests that disturbances of social functioning predict conversion to psychosis. Neurobiological evidence implicates glutamatergic dysfunction and redox imbalance in the pathophysiology of schizophrenia. The investigators hypothesize that interventions targeting (i) social functioning and (ii) glutamatergic / oxidative pathways already in at-risk states would significantly reduce transition rates. To test these hypotheses, our study is designed as a randomized, placebo-controlled, 18-month trial (six months of intervention plus 12 months of follow-up), involving 200 subjects at-risk for psychosis. Specifically, the investigators will compare the preventive effects of a cognitive-behavioural and social-cognitive intervention to a pharmacological intervention (IPPI) with Acetylcysteine, a drug with a proglutamatergic, neuroprotective and anti-inflammatory profile in a 2x2 factorial design. The results of our planned study are expected to provide new and well tolerated interventions, thus hopefully helping to achieve the major goal of individualized prevention, and, consequently, lower the individual and societal burden of psychosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| IPPI + NAC | Experimental | Drug: N-Acetylcysteine, Behavioral: IPPI (Integrated Preventive Psychological Intervention)IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater). N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention. Double-blinded. |
| PSM + NAC | Experimental | Drug: N-Acetylcysteine, Behavioral: PSM (Psychological stress management)PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater). N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention. Double-blinded. |
| IPPI + Placebo | Experimental | Drug: Placebo, Behavioral: IPPI (Integrated Preventive Psychological Intervention)IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater). Placebo will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM). |
| PSM + Placebo | Active comparator | Drug: Placebo, Behavioral: PSM (Psychological stress management)PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater). N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Placebo will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 - 40 years;
- Subjects with the ability to follow study instructions and likely to attend and complete all required visits;
- Written informed consent of the subject;
- Subjects are able to speak, write and understand the German language sufficiently well (at the investigators discretion) to complete all required study procedures;
- Clinical High Risk Criteria : ESPRIT Ultra-high risk criteria (Attenuated Positive Symptoms and/or Brief Llimited Intermittend Psychotic Symptoms and/or a combination of familial risk or schizotypal disorder with a significant loss of functioning; severity assessed by the Structured Interview for Prodromal Syndromes, SIPS 5.0) and/or The Basic Symptom Criterion 'Cognitive Disturbances, COGDIS' (2/9 cognitive-perceptive basic symptoms; assessed by the Schizophrenia Proneness Instrument - Adult Version, SPI-A)
Key exclusion criteria (22 listed)
- Known history of hypersensitivity to the investigational drug or to drugs with a similar chemical structure;
- Simultaneously participation in another clinical trial involving administration of an investigational medicinal product within 30 days prior to clinical trial beginning. The simultaneous participation in a noninterventional clinical trial is permitted in case the subject is nevertheless able and willing to attend and complete all required visits and in case there are no other contraindications;
- Subjects with a physical or psychiatric condition which at the investigator's discretion may put the subject at other clinically significant risks than those that are defined as outcome of this study (development of a first psychotic episode, functional deterioration), may confound the trial results, or may interfere with the subject's per protocol participation in this clinical trial;
- Acute Suicidality;
- Known substance abuse or dependence according to DSM-IV-TR;
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 |
|---|---|---|
| N-AcetylcysteineAlso: NACN-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention (IPPI or PSM). | Drug | IPPI + NAC, PSM + NAC |
| PlaceboWill be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM). | Drug | IPPI + Placebo, PSM + Placebo |
| IPPI (Integrated Preventive Psychological Intervention)IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician \& rater) | Behavioural | IPPI + NAC, IPPI + Placebo |
| PSM (Psychological stress management)PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician \& rater). | Behavioural | PSM + NAC, PSM + Placebo |
Primary outcome
Transition to psychosis
Time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Transition to psychosis within 18 months, defined (according to EPOS1) as the presence of at least one psychotic symptom for at least one week (assessed by the SIPS).
Psychosocial functioning
Time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Psychosocial functioning assessed by the SOFAS and the FROGS
4 secondary outcomes
Symptom remission
Time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Depression remission
Time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Improvement of social cognition
Time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Assessment of safety and tolerability
Time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)
Results and safety
The study was stopped early (reason given: Recruitment not sufficient). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-Acetylcysteine, IPPI (Integrated Preventive Psychological Intervention) and PSM (Psychological stress management) in people with Prodromal Schizophrenia, run by University Hospital, Bonn at 10 sites in Germany.
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 6 inclusion and 22 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 9 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany. 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: Recruitment not sufficient). 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?
Transition to psychosis (time frame: I. After intervention phase (26 weeks after trial start) and II. as follow-up (78 weeks after trial start)). 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?
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 9 May 2022.