Weight GainPhase 2NCT00759993
Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
A Phase 2 study testing chromium piccolinate in people with Weight Gain and Obesity, run by State University of New York - Upstate Medical University.
Trial summary
A majority of patients who suffer from mental illness are treated with serotonin regulating FDA approved medications. Some of these medications also block histamine transmission, increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote sedation. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Gain, Obesity
- What is being tested?
- chromium piccolinate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2008to Mar 2013
- Phase
- Phase 2
- 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
- Written informed consent is obtained.
- The subject is English-speaking and 18 through 64 years of age inclusive.
- The subject is currently receiving a serotonergic agent or is scheduled to receive a new or change in serotonergic psychotropic agents for their a psychiatric condition or can document that they have been on a stable regimen without any weight gain in last 3 months as a result.
- The subject must have capacity to obtain and give informed consent
- The subject must express concern about weight gain as a potential serotonin side effect.
- The patient is in good health as determined by a medical and psychiatric history, medical examination, and cannot have major medical illness that would jeopardize patient health during the study.
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- Women must be of nonchildbearing potential [i.e., postmenopausal, be surgically sterile (hysterectomy or tubal ligation)] or must meet all of the following conditions: using a reliable, medically accepted form of contraception for at least 60 days before the baseline visit, and agree to continue such use throughout the duration of the study and for 30 days after the final dose of study drug. Reliable forms of contraception include oral, implanted, or injected contraceptives; intrauterine devices in place for at least 3 months; and adequate double-barrier methods in conjunction with spermicide (abstinence is considered an acceptable contraceptive regimen).
- Women must be given a urine pregnancy test (ßHCG), unless they are at least 2 years postmenopausal or surgically sterile, and the results of the test must be negative.
- The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
- The patient must be a voluntary admission inpatient at SUNY Upstate Medical University's Psychiatric department in order to enroll in the study.
Who cannot join
- The patient lacks capacity to make medical decisions and ability to receive and utilize the informed consent process due to their mental illness.
- The patient is incapacitated by mental illness
- The patient is a significant risk of suicide as determined by the study team in this acute setting
- The patient has recently started a weight loss or exercise program or is taking an insulin resistance improving drug OR plans to start one upon discharge
- The patient has a co-morbid medical problem thought to induce weight gain or make it difficult to lose weight (ie hypothyroid, hypercortisol, diabetes…)
- The patient has previously ( in the last 2 months) lost or gained a significant amount of weight from any weight loss program, weight loss agent, or dietary medication.
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- The patient has used an investigational drug within 1 month before the screening visit or is participating in a concurrent clinical trial.
- The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery).
- The patient is highly unlikely to comply with the study protocol, be unreliable in providing ratings, or is unsuitable for any reason, as judged by the investigator.
- The patient has a clinically significant deviation from normal in the physical examination or medical history (renal or hepatic problems) which makes subject medically unstable at time of screening.
- The subject can not be currently on any medication that is clearly being used to lower weight. Examples include: Xenical, Metformin, Wellbutrin, Topomax, psycho-stimulants, and Moban.
About this study
Official title: A 6 Week, Blinded, Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
A majority of patients who suffer from mental illness are treated with serotonin regulating FDA approved medications. Some of these medications also block histamine transmission, increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote sedation. All of which lead to weight gain and obesity. Many of these drugs are generally safe and effective but do carry the risk of a long term side effect in that acute and gradual weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of 7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes, hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia… ) This therapeutic manipulation of brain serotonin functioning may be associated with abnormal increases in carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance occurs as a direct effect or as an indirect effect of weight gain, particularly in patients prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with feedback signaling that reduces appetite and adipose tissue growth may also become insensitive. These multiple insults may lead to the worst weight gain in patients taking clozapine, olanzapine, and mirtazapine.
Diet and exercise and lifestyle modification are the usual initial interventions, though being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make these changes. In fact most of the studies which look at these weight loss interventions occur in patients who are institutionalized, on restricted diets and may respond to token economy systems while on longer term inpatient unit stays. This token economy approach is not easily translated to usual outpatient or short term inpatient practice settings. In these settings, if lifestyle modification approaches fail, patients may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect risks. Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at an even greater side effect risk.
Read more
In a similar weight gain prone group, there is growing literature in the diabetes population that the use of high dose chromium improves (lowers) insulin resistance by way of increasing insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium piccolinate was studied in depressed patients, especially those with atypical features (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in depression symptoms overall, carbohydrate cravings improved. This paper was presented at the 2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute , clinically significant weightgain in serotonergically treated psychiatric inpatients. The authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus protect against weight gain side effects.
Given this pivotal paper in the depressed population, effectiveness data in the diabetes population and some possible metabolic ties between these two populations, the author wishes to study the effect of chromium piccolinate in mentally ill subjects who are being started on serotonergic manipulating medications while in an inpatient treatment setting. These patients will be followed during their inpatient stay and then be followed after discharge for a single visit to determine acute interventional effects of chromium piccolinate. We feel chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we currently use and therefore suggest a long term randomized, controlled study where subjects will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the Nutrition 21 company, which has been approved by the FDA as a source of this product.
- Conditions
- Weight Gain, Obesity
- Being tested
- chromium piccolinate, placebo for chromium piccolinate
- Keywords
- weight gain, Obesity, Psychiatry, Medication, Induced
- Medical subject headings
- Weight Gain, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chromium piccolinateDrug
1000mg tab
placebo for chromium piccolinateDrug
| Study group | Role | What they receive |
|---|---|---|
| A,1 | Experimental | chromium piccolinate 1000mg Receives: Drug: chromium piccolinate |
| A,2 | Placebo comparator | matching placebo Receives: Drug: placebo for chromium piccolinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body Weight
Measured: 6 weeks
Secondary outcomes (1)
BMI
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startSep 2008
- Primary completionJun 2012
- Study completionMar 2013 (estimated)
Why it stopped: inability to recruit and retain
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight GainStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Nutrition 21, Inc.
- Responsible party
- Principal investigator, Thomas L. Schwartz, M.D., State University of New York - Upstate Medical University
- Investigators
- Thomas L Schwartz, MD, Principal investigator, SUNY UpstateJames Megna, MD, Principal investigator, SUNY Upstate
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759993
- Sponsor's protocol ID
- crmpicc01
- Status last verified
- Sep 2012
- First submitted
- 24 Sep 2008
- Last updated
- 7 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6 Week, Blinded, Randomized, Controlled Pilot Study to Evaluate the Safety and Efficacy of Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
- ClinicalTrials.gov ID
- NCT00759993
- Acronym / sponsor ID
- crmpicc01
- Conditions
- Weight Gain, Obesity
- Keywords
- weight gain, Obesity, Psychiatry, Medication, Induced
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: inability to recruit and retain
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Collaborators
- Nutrition 21, Inc.
- Study start
- Sep 2008
- Primary completion
- Jun 2012 (actual)
- Study completion
- Mar 2013 (estimated)
- First posted
- 25 Sep 2008 (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.
A majority of patients who suffer from mental illness are treated with serotonin regulating FDA approved medications. Some of these medications also block histamine transmission, increase blood prolactin levels, induce insulin resistance, hyperlipidemia, and promote sedation. All of which lead to weight gain and obesity. Many of these drugs are generally safe and effective but do carry the risk of a long term side effect in that acute and gradual weight gain of 10-30 pounds over a few months to a year of treatment. The detrimental gain of 7% of pre-drug weight is reported with many antipsychotics, mood stabilizers and some antidepressants. This weight gain may subsequently add to medical co-morbidity ( ie diabetes, hypertension, osteoarthritis, coronary artery diseasem, hyperlipidemia… ) This therapeutic manipulation of brain serotonin functioning may be associated with abnormal increases in carbohydrate cravings, consumption and weight gain. It is possible that insulin resistance occurs as a direct effect or as an indirect effect of weight gain, particularly in patients prone to weight gain or diabetes due to genetic loading. Leptin, a chemical associated with feedback signaling that reduces appetite and adipose tissue growth may also become insensitive. These multiple insults may lead to the worst weight gain in patients taking clozapine, olanzapine, and mirtazapine.
Diet and exercise and lifestyle modification are the usual initial interventions, though being depressed, anxious, bipolar, or schizophrenic often interferes with the ability to make these changes. In fact most of the studies which look at these weight loss interventions occur in patients who are institutionalized, on restricted diets and may respond to token economy systems while on longer term inpatient unit stays. This token economy approach is not easily translated to usual outpatient or short term inpatient practice settings. In these settings, if lifestyle modification approaches fail, patients may be placed on FDA approved diet medications (sibutramine, orlistat, ionamin…) which carry significant side effect risks. Some patients are even placed on the epilepsy medications such as zonisamide or topiramate at an even greater side effect risk.
In a similar weight gain prone group, there is growing literature in the diabetes population that the use of high dose chromium improves (lowers) insulin resistance by way of increasing insulin binding to cells, receptor numbers, and insulin receptor kinase activity. Lower fasting blood glucose levels in the blood generally occurs. Some reports show a reduction in blood lipid/cholesterol levels at higher chromium dosing as well. Recently, chromium piccolinate was studied in depressed patients, especially those with atypical features (usually fatigue, weight gain, carbohydrate cravings). Although there was no change in depression symptoms overall, carbohydrate cravings improved. This paper was presented at the 2005 American Psychiatric Association Annual Meeting in Atlanta. As a foil, a few papers in non-diabetics,non-depressed healthy volunteers showed little to no effectiveness in lowering blood sugar levels. Furthermore, one investigator (JLM) has published data showing acute , clinically significant weightgain in serotonergically treated psychiatric inpatients. The authors theorize that the use of chromium may reduce carbohydrate craving, appetite and thus protect against weight gain side effects.
Given this pivotal paper in the depressed population, effectiveness data in the diabetes population and some possible metabolic ties between these two populations, the author wishes to study the effect of chromium piccolinate in mentally ill subjects who are being started on serotonergic manipulating medications while in an inpatient treatment setting. These patients will be followed during their inpatient stay and then be followed after discharge for a single visit to determine acute interventional effects of chromium piccolinate. We feel chromium piccolinate is less toxic/hazardous than many of the weght loss medications that we currently use and therefore suggest a long term randomized, controlled study where subjects will receive active drug (chromium piccolinate) or placebo at the start of any serotonergic treatment while inpatient. The chromium piccolinate and the placbo will be obtained from the Nutrition 21 company, which has been approved by the FDA as a source of this product.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A,1 | Experimental | Drug: chromium piccolinatechromium piccolinate 1000mg |
| A,2 | Placebo comparator | Drug: placebo for chromium piccolinatematching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Written informed consent is obtained.
- The subject is English-speaking and 18 through 64 years of age inclusive.
- The subject is currently receiving a serotonergic agent or is scheduled to receive a new or change in serotonergic psychotropic agents for their a psychiatric condition or can document that they have been on a stable regimen without any weight gain in last 3 months as a result.
- The subject must have capacity to obtain and give informed consent
- The subject must express concern about weight gain as a potential serotonin side effect.
Key exclusion criteria (11 listed)
- The patient lacks capacity to make medical decisions and ability to receive and utilize the informed consent process due to their mental illness.
- The patient is incapacitated by mental illness
- The patient is a significant risk of suicide as determined by the study team in this acute setting
- The patient has recently started a weight loss or exercise program or is taking an insulin resistance improving drug OR plans to start one upon discharge
- The patient has a co-morbid medical problem thought to induce weight gain or make it difficult to lose weight (ie hypothyroid, hypercortisol, diabetes…)
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 |
|---|---|---|
| chromium piccolinate1000mg tab | Drug | A,1 |
| placebo for chromium piccolinate | Drug | A,2 |
Primary outcome
Body Weight
Time frame: 6 weeks
1 secondary outcome
BMI
Time frame: 6 weeks
Results and safety
The study was stopped early (reason given: inability to recruit and retain). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2012.
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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.
Thomas L Schwartz, MD principal investigator
SUNY Upstate
James Megna, MD principal investigator
SUNY Upstate
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing chromium piccolinate in people with Weight Gain and Obesity, run by State University of New York - Upstate Medical University.
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 10 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: stopped early, as of the sponsor's last update on 7 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 (reason given: inability to recruit and retain). 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?
Body Weight (time frame: 6 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 7 Sep 2012.