Chronic SchizophreniaPhase 4NCT02298985
Curcumin Addition to Antipsychotic Treatment in Chronic Schizophrenia Patients
A Phase 4 study testing Curcumin in people with Chronic Schizophrenia, run by Beersheva Mental Health Center at 2 sites in Israel.
Trial summary
Schizophrenia is still remained one of the disabling disorders despite progress in treatment of mental disturbances. Ten to thirty percents of patients have a little or no benefit from treatment with all kinds of antipsychotics using adequate dosages and duration. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Schizophrenia
- What is being tested?
- Curcumin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 2 sitesIsrael
- Study dates
- Jan 2015to May 2017
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years, male or female
- DSM-IV criteria for schizophrenia.
- Ability and willingness to sign informed consent for participation in the study
- SANS (Scale of Negative Symptoms of Schizophrenia ) > 30 points
- Fixed antipsychotic dosages at least 3 months
- Steady mental state of patients at least 3 months
Who cannot join
- Current substance use disorder except nicotine dependence
- Regular use of NSAID (non-steroidal anti-inflammatory drugs)
- Cancer history
- Untreated or severe hypertension
- Poorly controlled diabetes mellitus Type I or Type II
- Chronic liver \& gallbladder diseases
Show all 11Show fewer
- Recent GERD (Gastroesophageal Reflux Disorder)
- Neurological disorders: epilepsy, stroke
- Hamilton Depression Scale Hamilton Depression Rating Scale (HAM-D-17 item) > 24 points
- Patients with a known hypersensitivity to curcumin
- Pregnant women or a woman who intends to become pregnant
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Beersheva Mental Health Center
Beersheva
Tirat Carmel Mental Health Center
Tirat Carmel, 84170
About this study
Official title: Curcumin as add-on to Antipsychotic Treatment in Chronic Schizophrenia Patients: A Randomized, Double-Blind, Placebo-controlled Study
Schizophrenia is still remained one of the disabling disorders despite progress in treatment of mental disturbances. Ten to thirty percents of patients have a little or no benefit from treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of these patients has remained a persistent public health problem since medication-resistant patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic schizophrenia patients.
Read the detailed description
Study Design This is a 24-week, randomized, double-blind, placebo-controlled investigation of 40 chronic schizophrenia patients.
Participants Forty patients will be drawn from the patient population of Be'er Sheva Mental Health Center. Recruitment period will last over 2 years.
Patients will be required to have a primary diagnosis of chronic schizophrenia as defined in DSM-IV with predominantly persistent negative signs.
The study will commence only after approval by the local Institutional Ethics Review Board ("Helsinki Committee"). Only willing subjects and able to provide written informed consent, after receiving a comprehensive explanation of the study procedures, will be included in the study. Confidentially will be ensured by means of a number coding system, and all completed research forms will be stored in secure areas.
Procedure Patients will continue receiving their regular antipsychotic medication. The dose will be kept constant for at least 3 months prior to entry and throughout the study period. Curcumin is provided as Curcumin Forte ® (Solgar Israel SupHerb). Circumin capsules are supplied as an 1000 mg soft gelatin capsule for three daily oral administration with meals. At entry patients will receive curcuma capsules (3000 mg/day, three capsules) or placebo in identical capsules in a randomized, double blind mode for 24 weeks: 20 patients will receive curcumin, and 20 patients - placebo.
Participants will be assessed at baseline and after 4, 8, 12, 16 and 24 weeks of treatment. In a case of treatment discontinuation for 24-week of the trial, patients will be followed until end of study period.
Outcome variables will be evaluated by scoring the severity of symptoms (positive, negative, and etc.), and side effects. In addition, liver function tests and a blood cell count will be monitored at baseline and during the study.
For analyzing the results, within-subject pre- and post-treatment responses would be subject to statistical procedures to evaluate whether curcumin can ameliorate the persistent negative symptoms in schizophrenia.
- Conditions
- Chronic Schizophrenia
- Being tested
- Curcumin, placebo
- Keywords
- curcumin; schizophrenia; neuroprotection
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CurcuminDrug
Also called placebo, regular antipsychotic medication
3 g/day (3 capsules/day) for 6 months
placeboDrug
Also called curcumin, regular antipsychotic medication
3 g/day (3 capsules/day) for 6 months
| Study group | Role | What they receive |
|---|---|---|
| curcumin | Active comparator | curcumin 3 g/day for 6 months Receives: Drug: Curcumin; Drug: placebo |
| placebo | Placebo comparator | curcumin 3 g/day for 6 months Receives: Drug: Curcumin; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Symptoms Scale (PANSS)
baseline and every week 4 up to 24 weeks
Measured: up to 24 weeks
Secondary outcomes (3)
Clinical Global Impression - Improvement (CGI-I)
baseline and every week 4 up to 24 weeks
Measured: up to 24 weeks
Clinical Global Impression - Severity of Adverse Events (CGI-SAE)
baseline and every week 4 up to 24 weeks
Measured: up to 24 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
baseline and every week 4 up to 24 weeks
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionJan 2017
- Study completionMay 2017
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 Chronic 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beersheva Mental Health Center
- Sponsor type
- Other government
- Collaborators
- Tirat Carmel Mental Health Center
- Responsible party
- Principal investigator, Vladimir Lerner, Beersheva Mental Health Center
- Investigators
- Vladimir Lerner, MD, PhD, Principal investigator, Ben-Gurion University of the Negev
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298985
- Sponsor's protocol ID
- VLJB-14
- Status last verified
- Jan 2019
- First submitted
- 18 Nov 2014
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Miodownik C, Lerner V, Kudkaeva N, Lerner PP, Pashinian A, Bersudsky Y, Eliyahu R, Kreinin A, Bergman J. Curcumin as Add-On to Antipsychotic Treatment in Patients With Chronic Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Neuropharmacol. 2019 Jul/Aug;42(4):117-122. doi: 10.1097/WNF.0000000000000344.
PubMed 31045590
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curcumin as add-on to Antipsychotic Treatment in Chronic Schizophrenia Patients: A Randomized, Double-Blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT02298985
- Acronym / sponsor ID
- VLJB-14
- Conditions
- Chronic Schizophrenia
- Keywords
- curcumin; schizophrenia; neuroprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Beersheva Mental Health CenterOther government
- Collaborators
- Tirat Carmel Mental Health Center
- Study start
- Jan 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 24 Nov 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.
Schizophrenia is still remained one of the disabling disorders despite progress in treatment of mental disturbances. Ten to thirty percents of patients have a little or no benefit from treatment with all kinds of antipsychotics using adequate dosages and duration. Treatment of these patients has remained a persistent public health problem since medication-resistant patients are often highly symptomatic. Curcumin is one of the main curcuminoids isolated from this perennial herb. It possesses a variety of pharmacological activities, including anti-inflammatory, antiproliferative, antioxidant, and neuroprotective effects and crosses the blood-brain barrier. The purpose of our suggested study is to examine the efficacy of curcumin as add-on the conventional antipsychotic psychopharmacotherapy in chronic schizophrenia patients.
Detailed description
Study Design This is a 24-week, randomized, double-blind, placebo-controlled investigation of 40 chronic schizophrenia patients.
Participants Forty patients will be drawn from the patient population of Be'er Sheva Mental Health Center. Recruitment period will last over 2 years.
Patients will be required to have a primary diagnosis of chronic schizophrenia as defined in DSM-IV with predominantly persistent negative signs.
The study will commence only after approval by the local Institutional Ethics Review Board ("Helsinki Committee"). Only willing subjects and able to provide written informed consent, after receiving a comprehensive explanation of the study procedures, will be included in the study. Confidentially will be ensured by means of a number coding system, and all completed research forms will be stored in secure areas.
Procedure Patients will continue receiving their regular antipsychotic medication. The dose will be kept constant for at least 3 months prior to entry and throughout the study period. Curcumin is provided as Curcumin Forte ® (Solgar Israel SupHerb). Circumin capsules are supplied as an 1000 mg soft gelatin capsule for three daily oral administration with meals. At entry patients will receive curcuma capsules (3000 mg/day, three capsules) or placebo in identical capsules in a randomized, double blind mode for 24 weeks: 20 patients will receive curcumin, and 20 patients - placebo.
Participants will be assessed at baseline and after 4, 8, 12, 16 and 24 weeks of treatment. In a case of treatment discontinuation for 24-week of the trial, patients will be followed until end of study period.
Outcome variables will be evaluated by scoring the severity of symptoms (positive, negative, and etc.), and side effects. In addition, liver function tests and a blood cell count will be monitored at baseline and during the study.
For analyzing the results, within-subject pre- and post-treatment responses would be subject to statistical procedures to evaluate whether curcumin can ameliorate the persistent negative symptoms in schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| curcumin | Active comparator | Drug: Curcumin, Drug: placebocurcumin 3 g/day for 6 months |
| placebo | Placebo comparator | Drug: Curcumin, Drug: placebocurcumin 3 g/day for 6 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18-60 years, male or female
- DSM-IV criteria for schizophrenia.
- Ability and willingness to sign informed consent for participation in the study
- SANS (Scale of Negative Symptoms of Schizophrenia ) > 30 points
- Fixed antipsychotic dosages at least 3 months
Key exclusion criteria (11 listed)
- Current substance use disorder except nicotine dependence
- Regular use of NSAID (non-steroidal anti-inflammatory drugs)
- Cancer history
- Untreated or severe hypertension
- Poorly controlled diabetes mellitus Type I or Type II
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 |
|---|---|---|
| CurcuminAlso: placebo, regular antipsychotic medication3 g/day (3 capsules/day) for 6 months | Drug | curcumin, placebo |
| placeboAlso: curcumin, regular antipsychotic medication3 g/day (3 capsules/day) for 6 months | Drug | curcumin, placebo |
Primary outcome
Positive and Negative Symptoms Scale (PANSS)
Time frame: up to 24 weeks
baseline and every week 4 up to 24 weeks
3 secondary outcomes
Clinical Global Impression - Improvement (CGI-I)
Time frame: up to 24 weeks
Clinical Global Impression - Severity of Adverse Events (CGI-SAE)
Time frame: up to 24 weeks
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: up to 24 weeks
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 15 Jan 2019.
- Derived from this study: PubMed 31045590Miodownik C, Lerner V, Kudkaeva N, Lerner PP, Pashinian A, Bersudsky Y, Eliyahu R, Kreinin A, Bergman J. Curcumin as Add-On to Antipsychotic Treatment in Patients With Chronic Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled Study. Clin Neuropharmacol. 2019 Jul/Aug;42(4):117-122. doi: 10.1097/WNF.0000000000000344.
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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.
Vladimir Lerner, MD, PhD principal investigator
Ben-Gurion University of the Negev
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Curcumin in people with Chronic Schizophrenia, run by Beersheva Mental Health Center at 2 sites 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 6 inclusion and 11 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 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
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?
Positive and Negative Symptoms Scale (PANSS) (time frame: up to 24 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 NCT02298985, 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 15 Jan 2019.