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Depressive Disorder, Major clinical trials

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NCT ID: NCT00086307 Completed - Major Depression Clinical Trials

Lexapro and Pramipexole and to Treat Major Depression

Start date: June 2004
Phase: Phase 2
Study type: Interventional

This study compares the effectiveness of the combination of antidepressants: Lexapro and Pramipexole, with the effectiveness of each antidepressant alone. Purpose: Patients between 18 and 65 years of age with Major Depressive Disorder without psychotic features may be eligible for this 9-week study. Candidates must currently be in a major depressive episode of at least 4 weeks' duration, have failed to respond to treatment with an SSRI (Prozac, Zoloft, Paxil, Luvox, Celexa), and not have failed to respond to more than four antidepressants for the current episode. Candidates are screened with a physical examination, psychiatric evaluation, blood tests, review of vital signs, height and weight measurements, electrocardiogram (ECG), urine test for illegal drugs, and pregnancy test for women. Participants are tapered off antidepressants or other medications prohibited during the study and remain drug-free for 1 week before starting treatment. They are then randomly assigned to take pramipexole and escitalopram, pramipexole alone, or escitalopram alone for 6 weeks. During the study, participants come to the clinic eight times for health assessments and symptoms assessments, which include a check of vital signs and rating scales for depression and anxiety, adverse events, and sexual functioning. Blood and urine samples are collected periodically to monitor health, detect pregnancy in women, and detect illicit drug use. At the end of the 6-week treatment period, participants have a physical examination, ECG, blood test, and check of vital signs. Short-term anti-depressant treatment is offered, and plans are made for long-term treatment. Atendemos pacientes de habla hispana.

NCT ID: NCT00084162 Completed - Clinical trials for Depression, Involutional

Neurocardiac Control in Major Depression

Start date: March 30, 2004
Phase: N/A
Study type: Observational

This study will examine how depression may influence the way the brain regulates heart function. Some researchers believe that depression may be a risk factor for some forms of heart disease. Right-handed healthy volunteers and patients with major depressive disorder who are between 18 and 50 years of age may be eligible for this study. Female candidates must be premenopausal. Patients must currently be experiencing a major depressive episode. All candidates are screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. They are interviewed about their psychiatric and medical history, current emotional state and sleep pattern, and family history of psychiatric disorders. They complete symptoms ratings scales for depression, anxiety, and negative thinking; history of alcohol and tobacco use; level of physical activity; socioeconomic status; overall level of functioning; and, for depressed patients, their depression type. Women candidates have their menstrual phase determined by the timing of their recent menstrual cycles and may undergo testing to determine the time of their ovulation. Participants undergo the following tests and procedures: - 12-minute walk/run test - This test measures the subject's general level of cardiorespiratory fitness. In a gymnasium in the NIH Clinical Center, the subject walks or runs as far as he or she can in 12 minutes. Blood pressure is measured before and after the exercise test, and heart rate is measured during exercise with a monitor worn around the chest. - Magnetic resonance imaging (MRI) - A brain MRI scan is done to obtain pictures of the brain anatomy. Electrocardiogram leads are placed on the subject's chest to measure the electrical activity of the heart during the scanning session. The subject lies on a narrow bed in the scanner, which is a narrow metal cylinder about 6 feet long. The scanning session takes up to 90 minutes. - Positron emission tomography (PET) - PET scanning produces images of the brain's blood flow. The subject is injected with a radiotracer (small amount of drug labeled with a radioactive substance) that is detected by a special camera to trace blood flow. During the scanning session, the subject lies still on a table. EKG leas are placed on the subject's chest to measure the electrical activity of the heart during the scan. A mask with holes for the eyes, ears, and mouth is placed over the subject's face to keep the head f...

NCT ID: NCT00078715 Completed - Clinical trials for Depression, Involutional

Rapid Antidepressant Effects of Yohimbine in Major Depression

Start date: March 2004
Phase: Phase 2
Study type: Interventional

This study examines if Yohimbine, when given during the sleep cycle, will improve symptoms of depression within a matter of hours. Purpose: This study will examine whether the drug yohimbine, given at a specific time during the sleep cycle, produces chemical changes in the brain similar to those that occur with sleep deprivation. It will also see if yohimbine can induce rapid (next day) antidepressant effects in patients with major depression. Total sleep deprivation for 36 hours improves mood in most patients with major depression in a matter of hours, but the response is usually short-lived. Understanding the chemical changes that occur in the body during sleep deprivation may help in the development of a rapidly acting antidepressant.Patients with major depressive disorder between 18 and 65 years of age may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, electrocardiogram, and blood and urine tests. Participants are hospitalized at the NIH Clinical Center for the study, as follows: Drug-free period: Patients are tapered off their anti-depression medications and remain drug-free for 1 week before beginning study phase 1. Study phase 1: Patients undergo sleep deprivation for 36 hours. Those whose depression improves with sleep deprivation initially and then worsens continue to phase 2. The day after sleep deprivation, patients undergo a lumbar puncture (spinal tap). For this test, a local anesthetic is given and a needle is inserted in the space between the bones in the lower back where the cerebrospinal fluid circulates below the spinal cord. A small amount of fluid is collected through the needle. Study phase 2: Patients spend 1 night in the sleep lab. A catheter (plastic tube) is placed in a vein in each arm-one to give yohimbine and the other to draw blood samples. A small monitor cuff is placed on a finger to measure the patient's blood pressure and blood oxygen levels during the night. While asleep, the patient receives a dose of yohimbine or placebo, given over 3 minutes. A lumbar puncture is done the following morning. Patients receive no medications for 6 days, and then the sleep lab procedure is repeated. Patients who received yohimbine in the previous experiment are switched to placebo, and those who were given placebo are switched to yohimbine.

NCT ID: NCT00075296 Completed - Clinical trials for Major Depressive Disorder

FMRI Study of Performance During a Probabilistic Reversal Learning Task in Depression

Start date: January 5, 2004
Phase: N/A
Study type: Observational

This study will examine how the brains of depressed people function during learning and respond to feedback. Participants perform a "probabilistic reversal learning task" to determine whether depressed people perform worse on a task than non-depressed people when they sometimes receive misleading negative feedback. Right-handed healthy volunteers, people with major depression who are currently depressed or have previously been depressed and people with bipolar depression between 18 and 50 years of age may be eligible for this study. Candidates are screened with a medical and psychiatric history, physical examination, electrocardiogram, blood and urine tests. They are also interviewed to evaluate mood, sleep, energy, work and school performance, and social relationships, and asked to answer questions to investigate whether any history of paranoia, panic attacks, obsession, compulsions, suicidal thoughts, eating disturbances, and alcohol or drug abuse is present. They complete rating scales for depression, anxiety, and negative thinking; history of alcohol and tobacco use; physical movement; socioeconomic status; overall level of functioning; and depression type. Finally, they undergo a battery of neuropsychological tests to assess general intelligence, handedness, and specific cognitive abilities, including memory and concentration. Participants perform the probabilistic reversal learning task either in a testing room seated in front of a computer or lying down while undergoing functional magnetic resonance imaging (FMRI). FMRI is a diagnostic test that uses a strong magnet and radio waves to obtain pictures of brain structure and function. For the scan, the subject lies on a narrow bed with a plastic-encased metal coil close to the head. The bed slides into the scanner - a small tunnel about 6 feet long. All subjects, whether in the testing room or in the MRI scanner, undergo the learning task as follows: Two patterns are presented on a computer screen. One pattern is designated "correct" and the other "incorrect." Subjects are asked to choose the correct pattern on each try and are provided feedback as to whether the response was right or wrong. Sometimes the rule changes, and the pattern that was correct is now wrong, and vice versa, so that the new correct pattern must be chosen. In addition, misleading feedback is sometimes given intentionally, indicating the subject chose the wrong pattern when in fact the response was correct. Subjects should change their response only when they are sure that the rule has changed, and not because they were incorrectly told that they were wrong. For patients undergoing MRI, blood flow in the different areas of the brain is measured during the test. After the test, outside the scanner, participants undergo additional tests of attention, memory, and concentration like those that were administered during the screening procedures.

NCT ID: NCT00075257 Completed - Clinical trials for Major Depressive Disorder

Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Start date: n/a
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the efficacy and safety of DVS-233 SR versus placebo treatment in reducing the relapse rate of depressive symptoms in subjects with major depressive disorder (MDD), and to compare the percentages of relapse in terms of time to relapse between DVS-233 SR and placebo treatment groups by using survival analysis. Secondary Objective: To assess the response of subjects on DVS-233 SR versus placebo for the clinical global evaluation, functionality, general well-being, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] < 7).

NCT ID: NCT00073762 Completed - Clinical trials for Major Depressive Disorder

Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Start date: n/a
Phase: Phase 3
Study type: Interventional

Primary Objective: To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo. Secondary Objective: To assess the response of subjects receiving DVS-233 SR for the clinical global evaluation, functionality, general wellbeing, pain, and absence of symptoms (Hamilton Psychiatric Rating Scale for Depression, 17-item [HAM-D17] less than or equal to 7) versus those subjects receiving placebo.

NCT ID: NCT00073203 Completed - Clinical trials for Major Depressive Disorder

A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder

Start date: n/a
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine the effectiveness of 2 target doses of R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely depressed adult subjects with major depressive disorder. Approximately 488 subjects will be involved in the study.

NCT ID: NCT00072774 Completed - Clinical trials for Major Depressive Disorder

Study Evaluating DVS-233 SR In Adult Outpatients With Major Depressive Disorder

Start date: n/a
Phase: Phase 3
Study type: Interventional

To compare the antidepressant efficacy and safety of subjects receiving DVS-233 SR versus subjects receiving placebo.

NCT ID: NCT00071123 Completed - Healthy Clinical Trials

Evaluating Brain Responses to Facial Expressions in Major Depressive Disorder

Start date: October 9, 2003
Phase: N/A
Study type: Observational

This study will evaluate emotional processing biases in the brain while viewing facial expressions in adults with current or remitted major depressive disorder and healthy volunteers.

NCT ID: NCT00071110 Completed - Depression Clinical Trials

Electroacupuncture for Major Depression

Start date: March 2004
Phase: Phase 2
Study type: Interventional

This study will compare the safety, efficacy, and tolerability of electroacupuncture (EA) and sham electroacupuncture (SA) for the treatment of major depression.