420 Clinical Trials for Various Conditions
During winter months in northern latitudes use of Joovv device on self-reported non-clinical mental health (aka mood), sleep and energy levels. Participants will also submit Withings and Oura activity and sleep data.
Seasonal Affective Disorder
While the prevalence of smoking in the United States general population has declined over the past 50 years, there has been little to no decline among people with mental health conditions. Affective Disorders (ADs) are the most common mental health conditions in the US, and over 40% of people with ADs are current smokers. A national policy of reducing the nicotine content of cigarettes has the potential to reduce tobacco use, dependence, and related adverse health outcomes. Controlled trials in psychiatrically-stable smokers have shown that reducing the nicotine content in cigarettes can reduce cigarettes per day (CPD), dependence and tobacco toxicant exposure, with few adverse consequences. The goal of the proposed trial is to experimentally model whether increasing the availability and appeal of an alternative, non-combusted source of nicotine (e-cigarettes) moderates the effect of altering the nicotine in cigarettes in smokers with ADs. Additionally, investigators will test whether allowing participants to personalize the flavor of the e-liquid alters any moderating effects their availability may have on tobacco cigarette smoking. Daily smokers with current ADs will be recruited at Brown University and the University of Vermont. Investigators will study two research cigarettes referred to here as Research Cigarette 1 (RC1) and Research Cigarette 2 (RC2). One of these cigarettes will be a normal nicotine content cigarette and the other will be a reduced nicotine content cigarette. Investigators will study two e-cigarette conditions referred to here as E-Cigarette Condition 1 (EC1) and E-Cigarette Condition 2 (EC2). Both e-cigarette conditions will involve the same commercially available devices and same nicotine-containing e-liquid, but in one condition that e-liquid will be available only in tobacco flavor while in the other condition that e-liquid will be available in multiple flavors from which participants can choose based on personal taste preference. Participants will be assigned to one of the following four study conditions: (1) RC1 only; (2) RC2 only; (3) RC2 + EC1; (4) RC2 + EC2. Participants will be asked to use only their assigned study products for 16 weeks. Outcome measures include total CPD, cigarette demand assessed by behavioral economics-based purchase tasks, craving, withdrawal, psychiatric symptoms, breath carbon monoxide (CO), biomarkers of tobacco toxicant exposure, brain function and structure, and airway inflammation (fractional nitric oxide concentration in exhaled breath \[FeNO\]).
Tobacco Use Disorder
Depressed patients unremitted after monotherapy with citalopram or bupropion will remit following six weeks treatment with the combination of citalopram and bupropion.
Depressive Illness
This study will examine extended exposure to cigarettes varying in nicotine content among disadvantaged women. Adults with affective disorders are at increased risk for smoking, nicotine dependence, and using high nicotine yield cigarettes and are also at significantly increased risk for smoking-related adverse health consequences, including site-specific cancers, heart disease, and premature death. Studies testing an innovative regulatory strategy of reducing the nicotine content of cigarettes to a non-addictive level have shown promising beneficial effects (decreased smoking rate, reduced toxicant exposure, and increased cessation) in the general population of smokers. However, these studies have uniformly excluded vulnerable populations like those with affective disorders who may respond differently considering their greater vulnerability to smoking and nicotine dependence. Thus, little is known scientifically about how this highly vulnerable subgroup of smokers might respond to a nicotine reduction policy. This project is designed to address that substantial knowledge gap. This same study was also conducted in two additional vulnerable populations under a similar protocol.
Tobacco Use Disorder
The primary objective of this study is to evaluate the effect of light therapy using a narrow 467nm light compared to a 580nm light in subjects with Seasonal Affective Disorder (SAD). It is hypothesized that the 467nm light will improve the symptoms of SAD better than the 580nm light.
Seasonal Affective Disorder
The investigators are looking for volunteers who have a history of Major Depressive Disorder, the Winter Blues, or Seasonal Affective Disorder or healthy volunteers who do not have a history of these disorders for a research study on genetics.
Seasonal Affective Disorder
This is a randomized, controlled clinical trial of inactivated negative ion generation or light-emitting photodiode therapy for Seasonal Affective Disorder (SAD, winter depression), for subjects with a DSM IV diagnosis of Major Depression, with Seasonal Pattern, Winter type, to examine efficacy of treatments for this condition. The trial has a 1 week baseline phase and a 4 week treatment phase.
Seasonal Affective Disorder
The purpose of this pilot study is to determine the safety and potential efficacy of sustained-release bupropion (Zyban®) for the treatment of nicotine dependence in patients with bipolar affective illness. It is hypothesized that bupropion will produce a significant enhancement of smoking abstinence compared to placebo and will be safe for use in these patients.
Bipolar Disorder
This study is designed to test whether low-field magnetic stimulation (LFMS) can relieve some of the symptoms of depression in bipolar disorder or major depression.
Depression, Bipolar Depression, Major Depressive Disorder
The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.
Seasonal Affective Disorder
The purpose of this pilot study is to assess feasibility and patient accessibility in order to design an adequately powered study to compare group cognitive behavioral therapy for insomnia (CBT-I) to quetiapine in non-demented patients aged 60 years or older with controlled bipolar disorder (I or II) or major depressive disorder who suffer from residual insomnia.
Insomnia
The purpose is to study treatments of Seasonal Affective Disorder (SAD).
Seasonal Affective Disorder
Recurrent fall/winter major depression (known as Seasonal Affective Disorder (SAD)) is a prevalent and disruptive disorder whose pathophysiological basis is unknown, but several hypotheses attribute a causal role to the circadian timing system. Bright white light exposure via the retina has been shown to reverse the symptoms of SAD. Recent physiological studies demonstrated the existence of retinal ganglion cells capable of transducing light input to the retinohypothalamic tract, the primary circadian afferent in humans. This retinohypothalamic system appears to be maximally sensitive to light in the 446-477nm (violet/blue) range. Using light-emitting diode (LED) technology, light of narrow bandwidths now can be delivered from a safe, relatively inexpensive device. We propose to contrast in SAD patients the efficacy and tolerability of 468 nm LED light from a portable 11cm x 6cm commercially-available device (GoLITEÔ) to a broader 400-700 nm wavelength LED-generated light housed in an identical device. The broad wavelength (white) light from our LED device is similar to that from cool-white fluorescent 10,000 lux devices currently the standard for treatment of SAD (see e.g., Lam \& Levitt, 1999). Twenty-four depressed SAD outpatients will be randomized to a 3-week trial of light therapy using either the narrow 468 nm LED source or the broader 400-700 nm LED source, each housed in a GoLITEÔ device. Subjects will be given devices and written instruction for administering daily treatments at home, 45min every (q) a.m. The devices will be described to subjects in terms of wavelength but not specifically described as "blue" or "white." Weekly depression ratings and assessments of adverse effects will be obtained by a trained rater blind to the treatment condition. Depressive symptoms will be rated weekly by the same trained clinician. The following hypotheses will be evaluated: * H1-- Depressed SAD patients will demonstrate greater antidepressant therapeutic benefit from the narrow-wavelength (blue) source than from the broad-wavelength (white) source. * H2-- Depressed SAD patients will manifest fewer adverse effects during treatment with the narrow-wavelength (blue) source than with the broad-wavelength (white) source.
Seasonal Affective Disorder
This study will assess the effectiveness of cognitive behavioral therapy (CBT) in treating seasonal affective disorder (SAD), commonly called the "winter blues."
Seasonal Affective Disorder, Depression
A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder
Seasonal Affective Disorder (SAD)
This is a placebo controlled study evaluating the effectiveness of medication in preventing depressive episodes in subjects with a history of Seasonal Affective Disorder (SAD).
Seasonal Affective Disorder
The purpose of this study is to determine what dose of a new timed-release tablet of the drug propranolol will reduce secretion of the hormone melatonin in healthy volunteers. This study will also determine whether suppressing melatonin will improve depressive symptoms in people with seasonal affective disorder (SAD). SAD (sometimes referred to as winter depression) is a condition in which people experience depression as a result of seasonal variations in light. Human brains have a circadian pacemaker that regulates many body functions. As the seasons change and light duration varies, the circadian pacemaker regulates seasonal behavior by transmitting a signal of day length to the pineal gland, which secretes the hormone melatonin. Melatonin secretion increases in the winter as the duration of light decreases. Evidence suggests that the melatonin signal of seasonal change is present in people with SAD but not in healthy volunteers; thus there is a possibility that seasonal changes which influence the duration of melatonin secretion control the course of illness in individuals with SAD. This study will determine whether propranolol can shorten the duration of melatonin secretion and mimic the effect of summer days to improve symptoms of depression in people with SAD. Healthy volunteers will be admitted to the hospital for about 2 days. The volunteers will receive either propranolol or placebo (an inactive pill) before going to bed and upon awakening. Blood samples will be collected at various times throughout the study. Participants with SAD will be interviewed periodically on an outpatient basis to determine the onset of depression in the fall or winter. Two weeks after depressive symptoms arise, participants will begin treatment with either propranolol or placebo. At the beginning of the treatment, participants will be hospitalized for about 2 days and will have blood collected at various times. During the hospital stay, participants will continue treatment with either propranolol or placebo in the morning and at night; all participants will receive propranolol at some point during the study. Participants will be interviewed weekly for 4 weeks. Premenopausal women with or without SAD will keep a record of their menstrual cycles and will use a urine test kit to identify the time of ovulation during the month before and after admission to the hospital.
Seasonal Affective Disorder, Healthy
This study is designed to evaluate repetitive transcranial magnetic stimulation (rTMS) as a potential treatment for depression. In rTMS, a rapidly changing magnetic field passes through your scalp and skull and generates a small electrical pulses in your brain. rTMS at lower intensities has helped some people with depression but we do not know what the results will be in your case using higher intensities, or whether you will be randomized to 3 weeks of high frequency (20 cycles er second), low frequency (1 cycle per second), or inactive (sham)rTMS. You will be assigned to receive one of these types of rTMS over the left front art of your brain five times per week for the three weeks. Each rTMS treatment session should take between 20-30 minutes of actual stimulation, but weekly ratings, memory testing, and blood sampling may require several hours per week. We will also ask you to have brain imaging procedures to see if these will predict response to high vs. low frequency rTMS. If you are randomized to the 3 weeks of sham rTMS, you will have the opportunity to receive one of the active stimulation frequencies for an additional 3 weeks. Responders to any phase will be offered an additional month of rTMS prior to study termination and recommendations of alternative treatments.
Bipolar Disorder, Mood Disorder, Unipolar Depression
As the seasons change during the course of the year, many animals show major changes in their behavior and physiology. Many of these changes are triggered by changes in the length of time each night that the pineal gland produces the hormone melatonin. Melatonin is produced for a longer time in winter when nights are long, than in summer when nights are short. Some researchers believe that melatonin may play a similar role in how season effects mood of patients with seasonal affective disorder. Seasonal affective disorder (SAD) or mood disorder with seasonal pattern is a condition where the normal biorhythm is disturbed during a season, especially autumn-winter. Patients may begin experiencing or experience worsening of depressive symptoms. Patients complain of being constantly tired, craving sugary foods, overeating, and over sleeping. Researchers have collected some preliminary data showing that the duration of nighttime melatonin secretion increases in winter and decreases in summer in healthy women, but not in healthy men. However, men diagnosed with SAD have shown longer duration of melatonin secretion in the winter, similar to the duration seen in healthy women. If these early findings are confirmed it may explain why SAD is more common in women than in men. The purpose of this study is to continue researching the differences in melatonin secretion over the seasons in healthy men and women, and to determine how these findings may apply to patients with SAD.
Seasonal Affective Disorder
This research study is the continuation of a study started more than 20 years ago. The study was designed to explore the effect that depressed parents have on their children and to better understand the factors that contribute to depression development and maintenance. The study will continue to investigate if children have certain characteristics in early and middle childhood that predict the later development of psychological disorders. In addition, the study will continue looking at the processes responsible for the development of children of parents with and without affective (mood) disorders.
Bipolar Disorder, Involutional Depression, Mood Disorder
The purpose of this research is to measure brain activity in individuals with mood disorders and memory problems using a simple, safe, and noninvasive method called functional near-infrared spectroscopy (fNIRS). By comparing brain activity across different groups and relating it to symptom severity, this study aims to improve our understanding of how these conditions affect the brain.
Major Depressive Disorder, Bipolar Disorder, Mild Cognitive Impairment
The current project is a pilot study that seeks to compare the efficacy of Brief Behavioral Activation's treatment-as-usual that uses paper and pencil tools to Kandoo, a digital, gamified version of activity scheduling and self-monitoring, in a diverse sample of youth presenting with clinically significant symptoms of depression. We will compare the level of pre- and post-treatment depressive symptoms in participants, who will participate in an 8-week brief behavioral activation treatment protocol augmented with Kandoo to the pre- and post- treatment depressive symptoms in the control participants, who will participate in 8-week, treatment as usual, brief behavioral activation treatment protocol. To explore treatment response for the clinically significant symptoms, we will obtain pre- and post-treatment measures of depression, global functioning, and patient goals. During the standard clinical intake, additional information will be obtained, including detailed demographics, medical history, mental health status, and social skills. Beyond determining the overall effectiveness of BBA augmented with Kandoo, the sample diversity and availability of clinical behavioral observations of the participants will permit the development of explanatory models of predictive factors for BBA with Kandoo intervention outcomes.
Depression Disorders
The purpose of this research study is to initiate a pharmacotherapy protocol for at-risk patients with newly diagnosed head and neck cancer in order to decrease the incidence of anxiety, depression, and uncontrolled pain during cancer treatment.
Depressive Disorder, Head and Neck Cancer
Although cognitive-behavioral therapy (CBT) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression), a significant limitation to the CBT's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. Mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. This study examines whether a mobile application-enhanced CBT can improve participant adherence and treatment acceptance for adolescents at high risk for SMD.
Adolescents, Mood Disorders
Background: More than 12,000 people have taken part in research at the Experimental Therapeutics \& Pathophysiology Branch at the National Institute of Mental Health Intramural Program. This has led to advances in the treatment of depression, bipolar disorder, and suicide risk. Researchers want to follow up with this group to see if they continue to have mental health symptoms and receive psychiatric treatments. Objective: To learn the long-term impact of depression, bipolar disorder, and suicide risk. Eligibility: Adults ages 18 and older who signed consent for Protocol 01-M-0254 over a year ago. Design: This study has 2 phases: an online phase and a telephone phase. It has no in-person or face-to-face contact. In Phase 1, participants will fill out online surveys. They will access the surveys through the study website. The questions will focus on their current thoughts and feelings. The surveys will also ask about their current treatments for their mental health symptoms. At the end of the surveys, they will be asked if they would like to take part in Phase 2. If so, they will mark yes. Phase 2 includes a phone interview. They will be contacted by email to schedule the interview. In Phase 2, participants will be asked more in-depth questions about how they are feeling. They will also be asked which psychiatric medicines and treatments they have used since they left NIH. In both phases, participants can skip any questions they do not want to answer. The online surveys will take 30 minutes to complete. The phone interview will last 1-4 hours. The information that participants give in this study may be linked to their other NIH research records.
Depression, Suicide Risk
This proposed 2-stage randomized controlled trial (RCT) will evaluate a personalized patient-centered adherence intervention iTAB-CV + Self-Monitoring (iTAB-CV + SM) vs. Self-Monitoring (SM) alone in poorly adherent hypertensive persons with BD or MDD. This practical, technology-facilitated intervention has potential to improve adherence to antihypertensive medication and reduce SBP among high-risk individuals. The intervention is suitable for primary care or mental health settings and has potential for broad scale-up.
Bipolar Disorder, Non-Adherence, Medication, Hypertension, Major Depressive Disorder
This multi-modal methods study will investigate neurophysiological, endocrinological, cognitive, psycho-social-emotional markers of disease, and targets for integrative health treatments in mood disorders.
Major Depressive Disorder, Depression, Stress
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.
Bipolar Disorder
The purpose of this study is to assess a novel nutritional supplement developed for prenatal health and mood benefits, and to determine whether there is preliminary evidence for efficacy in Menstrual Related Mood Disorders (MRMD), including PMS with Prominent Mood Symptoms and PMDD.
Premenstrual Syndrome, Premenstrual Dysphoric Disorder, Premenstrual Tension, Menstrual Related Mood Disorder
This study will explore whether the use of a medication, Ketamine, can help patients who come to the ER with thoughts of suicide by improving their mood and reducing thoughts of suicide. Ketamine has been used for this purpose in patients who have been hospitalized, but it has not been well studied in the ER. The investigators are first trying to show that patients and doctors in the ER find the treatment acceptable. The investigators also hope to determine whether Ketamine is effective in decreasing the severity of patient's suicidal thinking while in the ER. If this treatment works, future studies will look at whether it can help patients be discharged from the hospital earlier. Research Procedures: Patients will be enrolled into the study on a voluntary basis after the research assistant has fully explained all the risks and benefits of the study (informed consent). Research assistants, Emergency Department staff, and the Psychiatry team will help identify patients for the study. Patients will be asked to complete surveys measuring the degree of their suicidal thinking and mood. Additional information will be collected on patients such as their demographics, current medications, and medical problems. Patients in the study will receive the medication, Ketamine, which will be given through an intravenous catheter (IV) at a dose based on the patient's weight and slowly infused over 40 minutes. Patients will be monitored during their stay in the Emergency Department by Emergency Department physicians and nurses for any signs of side effects to the medication. Patients will be asked to complete several surveys at specific time periods after the administration of Ketamine. All patients in the study will receive usual psychiatric care in addition to the study medication.
Depressive Disorder, Major, Suicidal Ideation