SchizophreniaPhase 3NCT00211562
Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
A Phase 3 study testing Olanzapine, Omega 3, Vitamin E+C in people with Schizophrenia, run by Augusta University at 1 site in United States.
Trial summary
This research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Olanzapine, Omega 3, Vitamin E+C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Jan 2006
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 to 55
- VA outpatient
- Diagnosis of schizophrenia by DSM-IV criteria
- Active treatment with olanzapine
- Medically healthy
Who cannot join
- Diagnosis of MR
- MMSE score of < 26
- Not on a stable dose of olanzapine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
This research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. The chemicals are the result of the brain using the fat that subjects eat in their diet. Some medications may also change the amount of these chemicals in a person's blood.
Read the detailed description
To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.
- Conditions
- Schizophrenia
- Being tested
- Olanzapine, Omega 3, Vitamin E+C
- Keywords
- weight gain, weight gain supplementation, antioxidants, olanzapine
- Medical subject headings
- Schizophrenia, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olanzapine, Omega 3, Vitamin E+CDrug
No adverse event nor SAE noted.
| Study group | Role | What they receive |
|---|---|---|
| Olanzapine | Active comparator | Not described Receives: Drug: Olanzapine, Omega 3, Vitamin E+C |
| Omega 3 | Active comparator | Not described Receives: Drug: Olanzapine, Omega 3, Vitamin E+C |
| Vitamin E +C | Active comparator | Not described Receives: Drug: Olanzapine, Omega 3, Vitamin E+C |
What is being measured
The primary outcome is the main question the study is designed to answer.
PANSS
Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
Measured: 2003-2006
BMI
BMI match height and weight.
Measured: 2003-2006
Blood samples
Samples analyzed, PI analyzed and published. PI no longer with the institution.
Measured: 2003-2006
Secondary outcomes (1)
Cognitive assessments
BACS assessment. Data analyzed and published by the PI.
Measured: 2003-2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJan 2006
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 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- Peter Buckley, M.D., Principal investigator, VA MC/Medical College of Georgia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211562
- Sponsor's protocol ID
- Omega-3 Fatty Acids
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 24 Oct 2012
- Results posted
- No
Publications
Jones B, Basson BR, Walker DJ, Crawford AM, Kinon BJ. Weight change and atypical antipsychotic treatment in patients with schizophrenia. J Clin Psychiatry. 2001;62 Suppl 2:41-4.
PubMed 11232752
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Body Weight in Olanzapine Treated Schizophrenia Patients by Adjunctive Supplementation of Antioxidants (Vitamins E + C) Plus Omega-3 Fatty Acids
- ClinicalTrials.gov ID
- NCT00211562
- Acronym / sponsor ID
- Omega-3 Fatty Acids
- Conditions
- Schizophrenia
- Keywords
- weight gain, weight gain supplementation, antioxidants, olanzapine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Eli Lilly and Company, Medical Service Line ABRC, US Department of Veterans Affairs
- Study start
- Oct 2005
- Primary completion
- Jan 2006 (actual)
- First posted
- 21 Sep 2005 (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 research study helps to demonstrate that adding vitamins and fats (nutritional supplements) to a diet will help reduce body weight and improve the lipid profile. This will be done by examining the body weight and chemicals in the blood. The chemicals are the result of the brain using the fat that subjects eat in their diet. Some medications may also change the amount of these chemicals in a person's blood.
Detailed description
To demonstrate that supplementation of antioxidants and omega-3 fatty acids will improve clinical outcome including cognitive performance in olanzapine treated patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Olanzapine | Active comparator | Drug: Olanzapine, Omega 3, Vitamin E+C |
| Omega 3 | Active comparator | Drug: Olanzapine, Omega 3, Vitamin E+C |
| Vitamin E +C | Active comparator | Drug: Olanzapine, Omega 3, Vitamin E+C |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 55
- VA outpatient
- Diagnosis of schizophrenia by DSM-IV criteria
- Active treatment with olanzapine
- Medically healthy
Key exclusion criteria (3 listed)
- Diagnosis of MR
- MMSE score of < 26
- Not on a stable dose of olanzapine
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 |
|---|---|---|
| Olanzapine, Omega 3, Vitamin E+CNo adverse event nor SAE noted. | Drug | Olanzapine, Omega 3, Vitamin E +C |
Primary outcome
PANSS
Time frame: 2003-2006
Study completed in 2006. PI no longer with the institution. Study was closed accordingly to the HAC.
BMI
Time frame: 2003-2006
BMI match height and weight.
Blood samples
Time frame: 2003-2006
Samples analyzed, PI analyzed and published. PI no longer with the institution.
1 secondary outcome
Cognitive assessments
Time frame: 2003-2006
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
- Background: PubMed 11232752Jones B, Basson BR, Walker DJ, Crawford AM, Kinon BJ. Weight change and atypical antipsychotic treatment in patients with schizophrenia. J Clin Psychiatry. 2001;62 Suppl 2:41-4.
- Related InfoLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
Peter Buckley, M.D. principal investigator
VA MC/Medical College of Georgia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Olanzapine, Omega 3, Vitamin E+C in people with Schizophrenia, run by Augusta University at 1 site in United States.
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 5 inclusion and 3 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 24 Oct 2012. 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 United States. 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. 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?
PANSS (time frame: 2003-2006). The study lists 3 primary outcomes in all. 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 NCT00211562, 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 24 Oct 2012.