SchizophreniaPhase 4OFFERNCT02210962
Omega-3 Fatty Acids Efficacy in First-episode of Schizophrenia
A Phase 4 study testing essential fatty acids and olive oil in people with Schizophrenia, run by Medical University of Lodz at 1 site in Poland.
Trial summary
There is accumulating experimental evidence to suggest the role of essential fatty acids (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to be dysfunctional on early stages of schizophrenia, according to neurodevelopmental hypothesis. Read more about this study
- Who is it for?
- Ages 16 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- essential fatty acids and olive oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePoland
- Study dates
- Sep 2011to Feb 2015
- Phase
- Phase 4
- 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 16 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients diagnosed with schizophrenia using Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
- Patients aged between 16-35 years
- Signed informed consent (parallel parents consent for individuals under 18 years of age)
Who cannot join
- Patients taking fish oil supplements (a washout period of 6 months is required)
- Patients diagnosed with epilepsy or suffering from epileptic seizures
- Patients receiving anticoagulant medication e.g., Warfarin
- Patients receiving psychotherapy
- Chronic somatic diseases
- Psychoactive substance dependence
- Pregnancy and lactation
- Mental retardation or diagnosed organic brain injury
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Affective and Psychotic Disorders Medical University of Lodz
Lodz, Łódź Voivodeship, 92216
About this study
Official title: Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
There is accumulating experimental evidence to suggest the role of essential fatty acids (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to be dysfunctional on early stages of schizophrenia, according to neurodevelopmental hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular importance at the beginning of the illness. As a relatively safe option, EFA supplementation would be a preferable add on therapy in treating individuals with a first episode of schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up studies of EFA supplementation in FES patients were carried out. The demonstration of the efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would be a strong basis for further studies and prescribing EFAs for a large population of patients who are in the early stages of that debilitating illness.
- Conditions
- Schizophrenia
- Being tested
- essential fatty acids, olive oil
- Keywords
- early psychosis, chronic schizophrenia, first episode psychosis, omega-3 and omega-6 essential fatty acids, relapse prevention, efficacy
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
essential fatty acidsDietary supplement
Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
olive oilDietary supplement
Yellow capsules containing olive oil (placebo)
| Study group | Role | What they receive |
|---|---|---|
| essential fatty acids | Experimental | The experimental treatment is a food supplement containing fish oil. The daily dose of 4 capsules provides 1320 mg of eicosapentaenoic acid and 880 mg of docosahexaenoic acid, 26 weeks intervention Receives: Dietary Supplement: essential fatty acids |
| olive oil | Placebo comparator | Placebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention Receives: Dietary Supplement: olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
The Positive and Negative Syndrome Scale [64] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.
Measured: 8 and 26 weeks of supplementation
Secondary outcomes (12)
Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse
Measured: 26 weeks intervention plus 26 weeks observation
PANSS total, positive, negative and general psychopathology subscales
Measured: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Measured: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Clinical Global Impression (CGI)
Measured: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Global Assessment of Functioning (GAF)
Measured: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus
Measured: Baseline, 26 weeks
Cognitive performance using composite battery of neuropsychologic tests
Measured: Baseline, 8 and 26 weeks
Niacin Flush Skin Test
Measured: Baseline, 8 and 26 weeks
Side effects profile according to self-prepared questionnaire
Measured: Baseline, 4, 8, 26
Lymphocyte telomerase activity
Measured: Baseline, 8 and 26 weeks
Equivalent doses of antipsychotics used
Measured: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
Grey matter volume: a voxel based structural MRI assessment
Measured: Baseline, 8 and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startSep 2011
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (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.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomasz Pawelczyk, Medical University of Lodz
- Investigators
- Tomasz P Pawełczyk, MD, PhD, Principal investigator, Department of Affective and Psychotic Disorders Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210962
- Sponsor's protocol ID
- N N402 243435
- Acronym
- OFFER
- Status last verified
- Feb 2015
- First submitted
- 5 Aug 2014
- Last updated
- 18 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pawelczyk T, Grancow M, Kotlicka-Antczak M, Trafalska E, Gebski P, Szemraj J, Zurner N, Pawelczyk A. Omega-3 fatty acids in first-episode schizophrenia - a randomized controlled study of efficacy and relapse prevention (OFFER): rationale, design, and methods. BMC Psychiatry. 2015 May 2;15:97. doi: 10.1186/s12888-015-0473-2.
PubMed 25934131
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Omega-3 Fatty Acids in First-episode Schizophrenia - a Randomized Controlled Study of Efficacy and Relapse Prevention (OFFER). Rationale, Design, and Methods.
- ClinicalTrials.gov ID
- NCT02210962
- Acronym / sponsor ID
- OFFER / N N402 243435
- Conditions
- Schizophrenia
- Keywords
- early psychosis, chronic schizophrenia, first episode psychosis, omega-3 and omega-6 essential fatty acids, relapse prevention, efficacy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 7 Aug 2014 (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.
There is accumulating experimental evidence to suggest the role of essential fatty acids (EFA) in neuronal migration, pruning and synaptic plasticity. These processes are implied to be dysfunctional on early stages of schizophrenia, according to neurodevelopmental hypothesis. Numerous epidemiological and clinical trial data support the benefit of EFA rich diets in reducing symptoms in schizophrenia. An EFA rich diet might be of particular importance at the beginning of the illness. As a relatively safe option, EFA supplementation would be a preferable add on therapy in treating individuals with a first episode of schizophrenia (FES) and a short duration of psychotic symptoms. No long term follow-up studies of EFA supplementation in FES patients were carried out. The demonstration of the efficacy of the prophylactic properties of EFAs in relapse prevention in FES patients would be a strong basis for further studies and prescribing EFAs for a large population of patients who are in the early stages of that debilitating illness.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| essential fatty acids | Experimental | Dietary Supplement: essential fatty acidsThe experimental treatment is a food supplement containing fish oil. The daily dose of 4 capsules provides 1320 mg of eicosapentaenoic acid and 880 mg of docosahexaenoic acid, 26 weeks intervention |
| olive oil | Placebo comparator | Dietary Supplement: olive oilPlacebo capsules contain olive oil and trace amount of fish oil to assure comparable taste, 26 weeks intervention |
Who may qualify
- Ages
- 16 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with schizophrenia using Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
- Patients aged between 16-35 years
- Signed informed consent (parallel parents consent for individuals under 18 years of age)
Key exclusion criteria (8 listed)
- Patients taking fish oil supplements (a washout period of 6 months is required)
- Patients diagnosed with epilepsy or suffering from epileptic seizures
- Patients receiving anticoagulant medication e.g., Warfarin
- Patients receiving psychotherapy
- Chronic somatic diseases
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 |
|---|---|---|
| essential fatty acidsYellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active) | Dietary supplement | essential fatty acids |
| olive oilYellow capsules containing olive oil (placebo) | Dietary supplement | olive oil |
Primary outcome
The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia.
Time frame: 8 and 26 weeks of supplementation
The Positive and Negative Syndrome Scale [64] will be used to assess the efficacy of EPA+DHA supplementation in reducing symptom severity in first-episode schizophrenia after 8 and 26 weeks of supplementation. The main outcome measure will be the change in symptom severity from baseline to week 26. Baseline PANSS total score will be subtracted from PANSS score obtained after 26 weeks, resulting in the degree of change observed in the study.
12 secondary outcomes
Relapse rate - Positive and Negative Syndrome Scale (PANSS) defined schizophrenia relapse
Time frame: 26 weeks intervention plus 26 weeks observation
PANSS total, positive, negative and general psychopathology subscales
Time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Clinical Global Impression (CGI)
Time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
Global Assessment of Functioning (GAF)
Time frame: Baseline, 1, 2, 4, 6, 8, 16, 26, 52 weeks
A white matter directional organization metric: fractional anisotropy (FA) measured in two areas: corpus callosum and uncinate fasciculus
Time frame: Baseline, 26 weeks
Cognitive performance using composite battery of neuropsychologic tests
Time frame: Baseline, 8 and 26 weeks
Niacin Flush Skin Test
Time frame: Baseline, 8 and 26 weeks
Side effects profile according to self-prepared questionnaire
Time frame: Baseline, 4, 8, 26
Lymphocyte telomerase activity
Time frame: Baseline, 8 and 26 weeks
Equivalent doses of antipsychotics used
Time frame: Baseline, 1, 2, 4, 6, 8, 16, 26 and 52 weeks
Grey matter volume: a voxel based structural MRI assessment
Time frame: Baseline, 8 and 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2015.
- Derived from this study: PubMed 25934131Pawelczyk T, Grancow M, Kotlicka-Antczak M, Trafalska E, Gebski P, Szemraj J, Zurner N, Pawelczyk A. Omega-3 fatty acids in first-episode schizophrenia - a randomized controlled study of efficacy and relapse prevention (OFFER): rationale, design, and methods. BMC Psychiatry. 2015 May 2;15:97. doi: 10.1186/s12888-015-0473-2.
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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.
Tomasz P Pawełczyk, MD, PhD principal investigator
Department of Affective and Psychotic Disorders Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing essential fatty acids and olive oil in people with Schizophrenia, run by Medical University of Lodz at 1 site in Poland.
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 8 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 18 Feb 2015. 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 Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary outcome measure will be the efficacy of n-3 PUFA in reducing psychopathology in first-episode schizophrenia. (time frame: 8 and 26 weeks of supplementation). 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 NCT02210962, 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 18 Feb 2015.