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Last Updated: December 23, 2024

CLINICAL TRIALS PROFILE FOR IONAMIN


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All Clinical Trials for IONAMIN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00759993 ↗ Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units. Terminated Nutrition 21, Inc. Phase 2 2008-09-01 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.
NCT00759993 ↗ Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units. Terminated State University of New York - Upstate Medical University Phase 2 2008-09-01 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.
NCT01886937 ↗ Studying the Effects of Phentermine on Eating Behavior Completed AstraZeneca Phase 4 2012-07-01 The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.
NCT01886937 ↗ Studying the Effects of Phentermine on Eating Behavior Completed New York State Psychiatric Institute Phase 4 2012-07-01 The goal of this study is to determine whether one week of phentermine compared to placebo administration results in changes in food intake during a laboratory meal.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IONAMIN

Condition Name

Condition Name for IONAMIN
Intervention Trials
Obesity 2
Weight Gain 1
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Condition MeSH

Condition MeSH for IONAMIN
Intervention Trials
Body Weight 1
Weight Gain 1
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Clinical Trial Locations for IONAMIN

Trials by Country

Trials by Country for IONAMIN
Location Trials
United States 1
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Trials by US State

Trials by US State for IONAMIN
Location Trials
New York 1
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Clinical Trial Progress for IONAMIN

Clinical Trial Phase

Clinical Trial Phase for IONAMIN
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for IONAMIN
Clinical Trial Phase Trials
Completed 1
Terminated 1
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Clinical Trial Sponsors for IONAMIN

Sponsor Name

Sponsor Name for IONAMIN
Sponsor Trials
Nutrition 21, Inc. 1
State University of New York - Upstate Medical University 1
AstraZeneca 1
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Sponsor Type

Sponsor Type for IONAMIN
Sponsor Trials
Industry 2
Other 2
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