Clozapine Resistant SchizophreniaNCT01759485
Vitamin D for Schizophrenia
A study testing Vitamin D3 in people with Clozapine Resistant Schizophrenia, run by Geha Mental Health Center at 1 site in Israel.
Trial summary
Background: Despite improvements in medications, treatment delivery and rehabilitation, schizophrenia outcomes remain suboptimal. There are a proportion of 30-40% treatment-resistant schizophrenia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clozapine Resistant Schizophrenia
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteIsrael
- Study dates
- May 2014to 28 Feb 2017
- 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
- Males and females
- Age 18-65 years
- Diagnosis of schizophrenia according to DSM-IV-TR criteria, as confirmed by two senior psychiatrists
- Total PANSS score > 70
- CGI-S > 3
- Clozapine treatment for at least 18 weeks
Show all 9Show fewer
- Vitamin D deficiency: plasma 25-OH-Vitamin D <75 nmol/L (20-30 ng/mL)
- Able to consume oral drops of vitamin-D
- Able to sign informed consent
Who cannot join
- Mental retardation
- Organic brain disease
- Known parathyroid disorder
- Inborn/acquired vitamin D metabolism disorders
- Patients already treated with vitamin D supplementation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D Supplementation as Adjunct to Clozapine-treated Chronic Schizophrenia Patients
Background: Despite improvements in medications, treatment delivery and rehabilitation, schizophrenia outcomes remain suboptimal. There are a proportion of 30-40% treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin D is a neuro-active steroid that acts on brain development, leading to alterations in brain neurochemistry and adult brain function. Early deficiencies have been linked with neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease, depression and cognitive decline. Ecological studies support a potential role for vitamin D in schizophrenia. These data include studies that have explored the association between schizophrenia and winter/spring birth and also the apparent increased incidence and prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia patients, and the relation of disease severity to serum vitamin D levels. Methods: the investigators will use a prospective, interventional, longitudinal, double blinded, placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive (MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will be supplemented with vitamin D after the 8 weeks period, and then will be assessed again with the same protocol of vitamin D treated patients. All participants will be assessed again after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way ANOVA with repeated measures for comparison of vitamin D and control groups. The investigators will apply intention to treat and LOCF.
- Conditions
- Clozapine Resistant Schizophrenia
- Being tested
- Vitamin D3, placebo
- Keywords
- Clozapine, Schizophrenia, Vitamin-D, Treatment-resistant
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin D3Drug
Also called Cholecalciferol
once weekly oral drops preparation at a daily dose of 2000 IU X 7 = 14,000 IU per week (about 60 drops each week).
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Vitamin D | Active comparator | Supplementation of Vitamin D as add-on to the regular anti-psychotic treatment Receives: Drug: Vitamin D3 |
| Placebo | Placebo comparator | Placebo as oral drops once weekly as add-on to the regular anti-psychotic treatment Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive and Negative Syndrome Scale total score
Measured: Baseline to 8 weeks
Secondary outcomes (1)
Change in the MoCA Cognitive composite score
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2013 (estimated)
- Study startMay 2014
- Primary completionSep 2016
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clozapine Resistant 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geha Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir Krivoy, Geha Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01759485
- Sponsor's protocol ID
- GMHC-VITD
- Other IDs
- 29-12
- Status last verified
- Apr 2017
- First submitted
- 4 Dec 2012
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation as Adjunct to Clozapine-treated Chronic Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT01759485
- Acronym / sponsor ID
- GMHC-VITD
- Conditions
- Clozapine Resistant Schizophrenia
- Keywords
- Clozapine, Schizophrenia, Vitamin-D, Treatment-resistant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Geha Mental Health CenterUniversity, hospital or other
- Study start
- May 2014 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 3 Jan 2013 (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.
Background: Despite improvements in medications, treatment delivery and rehabilitation, schizophrenia outcomes remain suboptimal. There are a proportion of 30-40% treatment-resistant schizophrenia patients. Multiple lines of evidence suggest that vitamin D is a neuro-active steroid that acts on brain development, leading to alterations in brain neurochemistry and adult brain function. Early deficiencies have been linked with neuropsychiatric disorders, such as schizophrenia, and adult deficiencies have been associated with adverse brain outcomes, including Parkinson's disease, Alzheimer's disease, depression and cognitive decline. Ecological studies support a potential role for vitamin D in schizophrenia. These data include studies that have explored the association between schizophrenia and winter/spring birth and also the apparent increased incidence and prevalence of schizophrenia at higher latitudes. Objective: To evaluate the effect of vitamin-D supplementation on the mental state of clozapine-treated chronic schizophrenia patients, and the relation of disease severity to serum vitamin D levels. Methods: the investigators will use a prospective, interventional, longitudinal, double blinded, placebo-controlled, randomized design. The investigators will recruit 50 clozapine-treated chronic schizophrenia patients, with low level of serum vitamin-D, that will be randomly assigned (1:1 ratio) to receive either weekly oral drops of vitamin D (Cholecalciferol) or oral drops of placebo for 8 weeks follow-up. Repeated assessments will include: clinical severity scales (PANSS, CGI), side effects (SAS, BARS, clozapine side effects), cognitive (MoCA), metabolic parameters and laboratory data. Patients who were assigned to placebo will be supplemented with vitamin D after the 8 weeks period, and then will be assessed again with the same protocol of vitamin D treated patients. All participants will be assessed again after 24 weeks after vitamin D initiation. Analysis: the investigators will use on-way ANOVA with repeated measures for comparison of vitamin D and control groups. The investigators will apply intention to treat and LOCF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin D | Active comparator | Drug: Vitamin D3Supplementation of Vitamin D as add-on to the regular anti-psychotic treatment |
| Placebo | Placebo comparator | Drug: placeboPlacebo as oral drops once weekly as add-on to the regular anti-psychotic treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Males and females
- Age 18-65 years
- Diagnosis of schizophrenia according to DSM-IV-TR criteria, as confirmed by two senior psychiatrists
- Total PANSS score > 70
- CGI-S > 3
Key exclusion criteria (5 listed)
- Mental retardation
- Organic brain disease
- Known parathyroid disorder
- Inborn/acquired vitamin D metabolism disorders
- Patients already treated with vitamin D supplementation
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 |
|---|---|---|
| Vitamin D3Also: Cholecalciferolonce weekly oral drops preparation at a daily dose of 2000 IU X 7 = 14,000 IU per week (about 60 drops each week). | Drug | Vitamin D |
| placebo | Drug | Placebo |
Primary outcome
Change in Positive and Negative Syndrome Scale total score
Time frame: Baseline to 8 weeks
1 secondary outcome
Change in the MoCA Cognitive composite score
Time frame: Baseline to 8 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 13 Apr 2017.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D3 in people with Clozapine Resistant Schizophrenia, run by Geha Mental Health Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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.
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 in Positive and Negative Syndrome Scale total score (time frame: Baseline to 8 weeks). 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 13 Apr 2017.