Status:
TERMINATED
Chromium Piccolinate in the Prevention of Weight Gain Induced by Serotonergic Medications Initiated on Psychiatric Inpatient Units.
Lead Sponsor:
State University of New York - Upstate Medical University
Collaborating Sponsors:
Nutrition 21, Inc.
Conditions:
Weight Gain
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 prolac...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2013
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00759993
Start Date
September 1 2008
End Date
March 1 2013
Last Update
September 7 2012
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