SchizophreniaPEPS-RCTNCT02593058
Positive Emotions Program for Schizophrenia (PEPS)
A study testing Positive Emotions Program for Schizophrenia and Treatment As Usual in people with Schizophrenia and Schizoaffective Disorder, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
Trial summary
This study evaluates the addition of a 8 session psychological program, called Positive Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Positive Emotions Program for Schizophrenia and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2016to 31 Dec 2018
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a psychotic disorder according to ICD 10 (F20 or F25), diagnoses having been established by experienced clinicians;
- presenting a score of at least 2 on the overall SANS anhedonia scale;
- French-speaking;
- Ability to consent measured with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument.
Who cannot join
- evidence of organic brain disease, clinically significant concurrent medical ill/ness, or learning disability;
- no understanding of the study protocol as assessed with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1004
About this study
Official title: Positive Emotions Program for Schizophrenia (PEPS): A Randomized Controlled Study on Improving Pleasure and Motivation in Schizophrenia
This study evaluates the addition of a 8 session psychological program, called Positive Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with schizophrenia. Half of the participants will receive their usual treatment and PEPS in combination, while the other half will receive usual treatment only.
Read the detailed description
Recent literature has distinguished the negative symptoms associated with a diminished capacity to experience (apathy, anhedonia) from those which are associated with a limited capacity for expression (emotional blunting, alogia). The apathy-anhedonia syndrome tends to be associated with a poorer prognosis than the symptoms related to diminished expression, suggesting that it is the more severe facet of the psychopathology. However the efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. There is a clear clinical need for developing treatments for negative symptoms.
The Positive Emotions Programs for Schizophrenia (PEPS) teaches skills to help overcome defeatist thinking and to increase the anticipation and maintenance of positive emotions. PEPS involves eight one-hour group sessions, administered using visual and audio materials as part of a PowerPoint presentation of slides projected onto a screen.
The goal of the study is to establish if PEPS is clinically effective by using a randomized, controlled and assessor-blind trial. A combination of PEPS plus treatment as usual will be compared to treatment as usual alone. Participants diagnosed with a schizophrenia spectrum disorder will undergo either intervention for eight weeks. Testing will evaluate individuals' current psychopathology and ability to savor pleasure and will be performed at the time of inclusion, at the end of the eight-week intervention and at six month follow-up.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Positive Emotions Program for Schizophrenia, Treatment As Usual
- Keywords
- Anhedonia, Apathy, Negative symptoms, Anticipatory pleasure, Savoring
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Anhedonia, Lethargy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Emotions Program for SchizophreniaBehavioural
Also called PEPS
Each session of PEPS includes relaxation-meditation exercise, review of homework task given during the previous session, exercises to challenge defeatist beliefs. According to the session's theme, participants learn skills to improve their anticipation or maintenance of pleasure such as savoring a pleasant experience, expressing emotions by increasing behavioral expression, capitalizing on positive moments, and anticipating pleasant moments. A simple homework task is assigned to be done between each session. The pedagogical concept underpinning the program was built according to Kolb and Kolb's model of experiential learning. The program uses a collaborative, egalitarian approach.
Treatment As UsualBehavioural
Also called TAU
TAU consists of psychiatric management by a clinical team composed of at least one psychiatrist and a social worker and/or a psychiatric nurse with additional access to community treatment or hospital admission. Treatment involves antipsychotic medication, regular office-based or community contact with the clinical team for treatment monitoring, and socialization groups, therapy, and psychoeducational groups. No attempts have been made to standardize this treatment as TAU is tailored to the patient's specific needs.
| Study group | Role | What they receive |
|---|---|---|
| PEPS+TAU | Experimental | Eight one-hour weekly sessions of Positive Emotions Program for Schizophrenia (PEPS) + Treatment as Usual (TAU) Receives: Behavioral: Positive Emotions Program for Schizophrenia; Behavioral: Treatment As Usual |
| Treatment As Usual (TAU) | Active comparator | Treatment as usual - with no attempts to standardize this treatment as TAU is tailored to the patient's specific needs Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS).
The Scale for the Assessment of Negative Symptoms (SANS) measures schizophrenia's deficit symptoms within the framework of schizophrenic disorders. It comprises 25 items, scored from 0 to 5. A definition of each item, including examples, facilitates a better understanding of the scale's content. The rating system is ordinal, from 0 (absent) to 5 (severe). The twenty-five items are grouped into five components: 1) withdrawal or emotional poverty; 2) alogia (lack of speech); 3) avolition and apathy (lack of energy, lack of initiative); 4) anhedonia and social withdrawal (loss of interests); 5) attention. The scale was translated into French with acceptable validity. The composite score for the avolition-apathy and anhedonia-social withdrawal scale will be used as the main outcome variable.
Measured: Change from Baseline composite score at 2 months
Secondary outcomes (7)
Change on the Calgary Depression Scale for Schizophrenia (CDSS)
The Calgary Depression Scale for Schizophrenia (CDSS) includes nine items: depression, hopelessness, self-depreciation, guilty ideas of reference, pathological guilt, morning depression, early wakening, suicide, and observed depression. This scale has been validated in French.
Measured: Change from Baseline CDSS score at 2 months
Change on the Savoring Belief Inventory (SBI)
The Savoring Belief Inventory (SBI) is a self-reported scale for measuring beliefs about one's capacity for savoring things. The scale has twenty four items, including a positive scale (twelve items) and a negative scale (twelve items). The scale has good validity and a high test-re-test reliability. It measures a person's thinking regarding his/her capacity to savor positive experiences, in terms of past experiences, current experiences, and future anticipation. The total SBI score will be used as a secondary outcome variable.
Measured: Change from Baseline SBI total score at 2 months
Change on the Temporal Experience of Pleasure Scale (TEPS)
The Temporal Experience of Pleasure Scale (TEPS) is a self-reported scale and contains eighteen items included in two sub-scales: anticipatory pleasure (ten items) and consummatory pleasure (eight items). Items targeting anticipatory pleasure reflect the pleasure felt when anticipating a positive or pleasant stimulus. Items measuring consummatory pleasure refer to the direct pleasure experienced upon exposure to a stimulus. Items can be general or specific. The response to items falls on a six-point Likert scale from 1 (very false for me) to 6 (very true for me). This scale has been validated in French.
Measured: Change from Baseline TEPS scales at 2 months
Change on the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
The Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) is designed to assess one's ability to experience pleasure in the interpersonal domain. It is a seventeen-item self-reported measure that consists of seven anticipatory and ten consummatory items. The ACIPS is scored on a six-point Likert scale, ranging from 1 (very false for me) to 6 (very true for me). The format is therefore quite similar to that of TEPS. The difference between the two scales lies mainly in terms of the items' content.
Measured: Change from Baseline ACIPS scales at 2 months
Change on the Social Functioning Scale (SFS)
The Social Functioning Scale (SFS) is constructed to assess those areas of functioning that are crucial to the community maintenance of individuals with schizophrenia. This is a reliable, valid, sensitive instrument and responsive to change. This last scale will be completed by the case-manager of the participant.
Measured: Change from Baseline SFS at 8 months
Change on the Calgary Depression Scale for Schizophrenia (CDSS)
The Calgary Depression Scale for Schizophrenia (CDSS) includes nine items: depression, hopelessness, self-depreciation, guilty ideas of reference, pathological guilt, morning depression, early wakening, suicide, and observed depression. This scale has been validated in French.
Measured: Change from Baseline CDSS score at 8 months
Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS)
The Scale for the Assessment of Negative Symptoms (SANS) measures schizophrenia's deficit symptoms within the framework of schizophrenic disorders. It comprises 25 items, scored from 0 to 5. A definition of each item, including examples, facilitates a better understanding of the scale's content. The rating system is ordinal, from 0 (absent) to 5 (severe). The twenty-five items are grouped into five components: 1) withdrawal or emotional poverty; 2) alogia (lack of speech); 3) avolition and apathy (lack of energy, lack of initiative); 4) anhedonia and social withdrawal (loss of interests); 5) attention. The scale was translated into French with acceptable validity. The composite score for the avolition-apathy and anhedonia-social withdrawal scale will be used as the main outcome variables.
Measured: Change from Baseline composite score at 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study start1 Feb 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut et Haute Ecole de la Santé la Source
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Principal investigator, Jérôme Favrod, Institut et Haute Ecole de la Santé la Source
- Investigators
- Jérôme Favrod, Principal investigator, Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593058
- Sponsor's protocol ID
- 105319_163355 / 1
- Acronym
- PEPS-RCT
- Status last verified
- Mar 2019
- First submitted
- 29 Oct 2015
- Last updated
- 25 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Favrod J, Nguyen A, Fankhauser C, Ismailaj A, Hasler JD, Ringuet A, Rexhaj S, Bonsack C. Positive Emotions Program for Schizophrenia (PEPS): a pilot intervention to reduce anhedonia and apathy. BMC Psychiatry. 2015 Sep 29;15:231. doi: 10.1186/s12888-015-0610-y.
PubMed 26419356Favrod J, Giuliani F, Ernst F, Bonsack C. Anticipatory pleasure skills training: a new intervention to reduce anhedonia in schizophrenia. Perspect Psychiatr Care. 2010 Jul;46(3):171-81. doi: 10.1111/j.1744-6163.2010.00255.x.
PubMed 20591125Golay P, Thonon B, Nguyen A, Fankhauser C, Favrod J. Confirmatory Factor Analysis of the French Version of the Savoring Beliefs Inventory. Front Psychol. 2018 Feb 19;9:181. doi: 10.3389/fpsyg.2018.00181. eCollection 2018.
PubMed 29515496Chaix J, Golay P, Fankhauser C, Nguyen A, Gooding DC, Favrod J. Confirmatory Factor Analysis of the French Version of the Anticipatory and Consummatory Interpersonal Pleasure Scale. Front Psychol. 2017 Jul 28;8:1296. doi: 10.3389/fpsyg.2017.01296. eCollection 2017.
PubMed 28804473Nguyen A, Frobert L, McCluskey I, Golay P, Bonsack C, Favrod J. Development of the Positive Emotions Program for Schizophrenia: An Intervention to Improve Pleasure and Motivation in Schizophrenia. Front Psychiatry. 2016 Feb 17;7:13. doi: 10.3389/fpsyt.2016.00013. eCollection 2016.
PubMed 26924992Favrod J, Nguyen A, Chaix J, Pellet J, Frobert L, Fankhauser C, Ismailaj A, Brana A, Tamic G, Suter C, Rexhaj S, Golay P, Bonsack C. Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. Psychother Psychosom. 2019;88(2):84-95. doi: 10.1159/000496479. Epub 2019 Feb 18.
PubMed 30783071
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Emotions Program for Schizophrenia (PEPS): A Randomized Controlled Study on Improving Pleasure and Motivation in Schizophrenia
- ClinicalTrials.gov ID
- NCT02593058
- Acronym / sponsor ID
- PEPS-RCT / 105319_163355 / 1
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Anhedonia, Apathy, Negative symptoms, Anticipatory pleasure, Savoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Institut et Haute Ecole de la Santé la SourceUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- 1 Feb 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 30 Oct 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.
This study evaluates the addition of a 8 session psychological program, called Positive Emotions Program for Schizophrenia (PEPS) to improve motivation and pleasure in adults with schizophrenia. Half of the participants will receive their usual treatment and PEPS in combination, while the other half will receive usual treatment only.
Detailed description
Recent literature has distinguished the negative symptoms associated with a diminished capacity to experience (apathy, anhedonia) from those which are associated with a limited capacity for expression (emotional blunting, alogia). The apathy-anhedonia syndrome tends to be associated with a poorer prognosis than the symptoms related to diminished expression, suggesting that it is the more severe facet of the psychopathology. However the efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited. There is a clear clinical need for developing treatments for negative symptoms.
The Positive Emotions Programs for Schizophrenia (PEPS) teaches skills to help overcome defeatist thinking and to increase the anticipation and maintenance of positive emotions. PEPS involves eight one-hour group sessions, administered using visual and audio materials as part of a PowerPoint presentation of slides projected onto a screen.
The goal of the study is to establish if PEPS is clinically effective by using a randomized, controlled and assessor-blind trial. A combination of PEPS plus treatment as usual will be compared to treatment as usual alone. Participants diagnosed with a schizophrenia spectrum disorder will undergo either intervention for eight weeks. Testing will evaluate individuals' current psychopathology and ability to savor pleasure and will be performed at the time of inclusion, at the end of the eight-week intervention and at six month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PEPS+TAU | Experimental | Behavioral: Positive Emotions Program for Schizophrenia, Behavioral: Treatment As UsualEight one-hour weekly sessions of Positive Emotions Program for Schizophrenia (PEPS) + Treatment as Usual (TAU) |
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment As UsualTreatment as usual - with no attempts to standardize this treatment as TAU is tailored to the patient's specific needs |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- a psychotic disorder according to ICD 10 (F20 or F25), diagnoses having been established by experienced clinicians;
- presenting a score of at least 2 on the overall SANS anhedonia scale;
- French-speaking;
- Ability to consent measured with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument.
Key exclusion criteria (2 listed)
- evidence of organic brain disease, clinically significant concurrent medical ill/ness, or learning disability;
- no understanding of the study protocol as assessed with the San Diego Brief Assessment of Capacity to Consent (UBACC)-a decisional capacity instrument
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 |
|---|---|---|
| Positive Emotions Program for SchizophreniaAlso: PEPSEach session of PEPS includes relaxation-meditation exercise, review of homework task given during the previous session, exercises to challenge defeatist beliefs. According to the session's theme, participants learn skills to improve their anticipation or maintenance of pleasure such as savoring a pleasant experience, expressing emotions by increasing behavioral expression, capitalizing on positive moments, and anticipating pleasant moments. A simple homework task is assigned to be done between each session. The pedagogical concept underpinning the program was built according to Kolb and Kolb's model of experiential learning. The program uses a collaborative, egalitarian approach. | Behavioural | PEPS+TAU |
| Treatment As UsualAlso: TAUTAU consists of psychiatric management by a clinical team composed of at least one psychiatrist and a social worker and/or a psychiatric nurse with additional access to community treatment or hospital admission. Treatment involves antipsychotic medication, regular office-based or community contact with the clinical team for treatment monitoring, and socialization groups, therapy, and psychoeducational groups. No attempts have been made to standardize this treatment as TAU is tailored to the patient's specific needs. | Behavioural | PEPS+TAU, Treatment As Usual (TAU) |
Primary outcome
Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS).
Time frame: Change from Baseline composite score at 2 months
The Scale for the Assessment of Negative Symptoms (SANS) measures schizophrenia's deficit symptoms within the framework of schizophrenic disorders. It comprises 25 items, scored from 0 to 5. A definition of each item, including examples, facilitates a better understanding of the scale's content. The rating system is ordinal, from 0 (absent) to 5 (severe). The twenty-five items are grouped into five components: 1) withdrawal or emotional poverty; 2) alogia (lack of speech); 3) avolition and apathy (lack of energy, lack of initiative); 4) anhedonia and social withdrawal (loss of interests); 5) attention. The scale was translated into French with acceptable validity. The composite score for the avolition-apathy and anhedonia-social withdrawal scale will be used as the main outcome variable.
7 secondary outcomes
Change on the Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Change from Baseline CDSS score at 2 months
Change on the Savoring Belief Inventory (SBI)
Time frame: Change from Baseline SBI total score at 2 months
Change on the Temporal Experience of Pleasure Scale (TEPS)
Time frame: Change from Baseline TEPS scales at 2 months
Change on the Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS)
Time frame: Change from Baseline ACIPS scales at 2 months
Change on the Social Functioning Scale (SFS)
Time frame: Change from Baseline SFS at 8 months
Change on the Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Change from Baseline CDSS score at 8 months
Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS)
Time frame: Change from Baseline composite score at 8 months
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 25 Mar 2019.
- Background: PubMed 26419356Favrod J, Nguyen A, Fankhauser C, Ismailaj A, Hasler JD, Ringuet A, Rexhaj S, Bonsack C. Positive Emotions Program for Schizophrenia (PEPS): a pilot intervention to reduce anhedonia and apathy. BMC Psychiatry. 2015 Sep 29;15:231. doi: 10.1186/s12888-015-0610-y.
- Background: PubMed 20591125Favrod J, Giuliani F, Ernst F, Bonsack C. Anticipatory pleasure skills training: a new intervention to reduce anhedonia in schizophrenia. Perspect Psychiatr Care. 2010 Jul;46(3):171-81. doi: 10.1111/j.1744-6163.2010.00255.x.
- Background: PubMed 29515496Golay P, Thonon B, Nguyen A, Fankhauser C, Favrod J. Confirmatory Factor Analysis of the French Version of the Savoring Beliefs Inventory. Front Psychol. 2018 Feb 19;9:181. doi: 10.3389/fpsyg.2018.00181. eCollection 2018.
- Background: PubMed 28804473Chaix J, Golay P, Fankhauser C, Nguyen A, Gooding DC, Favrod J. Confirmatory Factor Analysis of the French Version of the Anticipatory and Consummatory Interpersonal Pleasure Scale. Front Psychol. 2017 Jul 28;8:1296. doi: 10.3389/fpsyg.2017.01296. eCollection 2017.
- Background: PubMed 26924992Nguyen A, Frobert L, McCluskey I, Golay P, Bonsack C, Favrod J. Development of the Positive Emotions Program for Schizophrenia: An Intervention to Improve Pleasure and Motivation in Schizophrenia. Front Psychiatry. 2016 Feb 17;7:13. doi: 10.3389/fpsyt.2016.00013. eCollection 2016.
- Results publication: PubMed 30783071Favrod J, Nguyen A, Chaix J, Pellet J, Frobert L, Fankhauser C, Ismailaj A, Brana A, Tamic G, Suter C, Rexhaj S, Golay P, Bonsack C. Improving Pleasure and Motivation in Schizophrenia: A Randomized Controlled Clinical Trial. Psychother Psychosom. 2019;88(2):84-95. doi: 10.1159/000496479. Epub 2019 Feb 18.
- Intervention description and materialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jérôme Favrod principal investigator
Institut et Haute Ecole de la Santé la Source & Service de psychiatrie communautaire du Département de psychiatrie du Centre Hospitalier Universitaire Vaudois
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Emotions Program for Schizophrenia and Treatment As Usual in people with Schizophrenia and Schizoaffective Disorder, run by Institut et Haute Ecole de la Santé la Source at 1 site in Switzerland.
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 4 inclusion and 2 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 25 Mar 2019. 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 Switzerland. 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?
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?
Change on the composite score of apathy/avolition and anhedonia/asociality ot the Scale for the Assessment of Negative Symptoms (SANS). (time frame: Change from Baseline composite score at 2 months). 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 NCT02593058, which also lists 6 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 25 Mar 2019.