
An Open Label Trial of TMS Therapy for Bipolar Depression
Bipolar DepressionTranscranial Magnetic Stimulation (TMS) is an increasingly accepted neurostimulation- based treatment for major depressive disorder. While there is a growing anecdotal database supporting its use in bipolar depression the investigators propose to collect open label efficacy and safety data in a small population of patients with clinically verified bipolar disorder.

Aerobic Exercise as add-on Treatment for Inpatients With Depression
DepressionThe aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as adon treatment for moderately to severely depressed inpatients. Endpoints are symptom severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV). Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post (+6weeks) in already existing blood samples.

NeuroQore rTMS (Monophasic vs. Biphasic) for Major Depressive Disorder: A Randomized Controlled...
Depressive DisorderMajorMajor depressive disorder (MDD) is a debilitating illness that affects millions of individuals in North America and can result in clinical symptoms including loss of pleasure and feelings of worthlessness, in addition to significant cognitive impairments (e.g., memory, attention) that affect daily functioning. Major depression bears a heavy burden for the individuals and family members afflicted, as well as an enormous health care and economic cost. Approximately half of major depressive patients seek out treatment for their illness and only 20% of those individuals report their treatment as satisfactory. Many MDD patients do not respond to pharmacological therapy following the first course of treatment, resulting in the need for alternative measures to alleviate the clinical and cognitive symptoms of treatment-resistant depression and the targeting of these therapies to better suit each individual patient. Repetitive transcranial magnetic stimulation (rTMS) is a well-accepted, non-invasive technique that utilizes currents to induce electrical fields that excite specific brain regions. The current recommended practice of rTMS involves the administration of a biphasic stimulus waveform; however, a novel method using monophasic pulses may prove more effective for the treatment of depression. The present study aims to determine the effect of monophasic rTMS compared to biphasic rTMS on cognitive processing in MDD patients through electrophysiological recordings of the brain taken before and after 6 weeks of stimulation. Additionally, the study aims to investigate various biological markers linked to clinical rTMS response; these brain markers will help in personalizing treatment for individuals suffering from MDD.

Study of the Efficacy of a Fixed-dose Regimen of Cariprazine Compared to Placebo for Treatment of...
Bipolar DisorderDepressionThis study is designed to prospectively confirm the efficacy of a fixed-dose regimen of cariprazine 1.5 milligrams (mg)/day or 3 mg/day compared to placebo for treatment of the depressive episode in participants with bipolar I disorder. The safety and tolerability of the fixed-dose regimens will be evaluated.

The Effects of JNJ-39393406 on Psychometric Performance and Residual Depressive
DepressionTo evaluate the effects of the nicotinic allosteric modulator JNJ-39393406 on psychometric performance and residual depressive symptoms in patients who have been diagnosed with unipolar and bipolar depression but currently DO NOT meet criteria for an episode of Major Depression or Manic Episode.

Evaluating a Novel Internet Intervention for Persons With Epilepsy and Depression
DepressionEpilepsyThe trial aims to evaluate the effectiveness of a novel internet intervention (Desiconnect), which was designed to introduce relevant cognitive-behavioral therapy (CBT) techniques to Persons with Epilepsy (PwE) and comorbid depression. Therefore, 200 PwE and a current depressive disorder (major depressive disorder or dysthymic disorder) will be recruited and randomized to two groups: (1) a control group, in which they may engage with any epilepsy treatment (Care-as-Usual, CAU) and receive access to Desiconnect after a delay of three months (i.e., CAU/wait list control group), or (2) to a treatment group that immediately receives six-month access to Desiconnect and may also use CAU. The primary outcome measure is the depression scale of the Patient Health Questionnaire (PHQ-9), collected at three months post-baseline.

Using Computer Tasks to Predict Response to Antidepressants
DepressionIn England over 800,000 patients each year are either newly diagnosed with depression or present with a new episode of depression in primary care. The majority of patients do not respond to the first drug prescribed and have to try several different antidepressants before an effective treatment is found. Antidepressants have a slow clinical onset of action, taking 4 to 6 weeks before changes in mood become apparent. No test exists to guide General Practitioners (GPs) as to whether their patient is responding to the prescribed successive treatments. This often results in delays of many months before patients return to good mental health. The GP-ETB is a set of computer-based emotional processing tasks. It was developed and optimised to be sensitive to early changes in emotional bias that are indicative of successful antidepressant treatment. The current investigation is an exploratory study using the GP-ETB. It will test the predictive ability of the GP-ETB with regard to later subjective drug response and nonresponse. The study will recruit depressed patients from primary care settings. There are no study drugs prescribed as part of this clinical investigation. Eligible patients will have been prescribed citalopram by their GP prior to study entry. The decision to initiate treatment with citalopram will be independent of study participation. The duration of the study is 5 months. Each patient will be required to attend 3 visits and total duration of the study for the patient will be 46 weeks. During the visits patients will be asked to complete a variety of questionnaires and GP-ETB tasks on the computer. Sensitivity and specificity data collected during this study will be used to develop a computer algorithm intended to predict response at 46 weeks, based on GP-ETB data collected 1 week after initiation of antidepressant treatment.

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine...
Treatment-resistant DepressionThe purpose of this study is to compare the efficacy and safety of switching treatment-resistant depression (TRD) participants from a prior antidepressant treatment (to which they have not responded) to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo.

A Trial of Sertraline vs. CBT for End-stage Renal Disease Patients With Depression {ASCEND}
DepressionEnd Stage Renal DiseasePatients whose kidneys fail generally require dialysis treatments to sustain life. The ability of patients to make major adjustments in their lives for dialysis is hampered by depression that affects almost one-quarter of such individuals. There are no studies that have adequately tested whether treatment of depression is effective in dialysis patients and if there is any difference between the response to the two most commonly available forms of treatment, psychotherapy and anti-depressant drug therapy. To fill this important gap in the investigators knowledge, the investigators propose to undertake (1) a randomized controlled clinical trial of 200 patients to test whether an engagement interview will result in a higher proportion of dialysis patients accepting treatment for depression; and (2) a randomized controlled clinical trial of 120 patients to determine whether there is any difference in the likelihood of improvement of depressive symptoms with psychotherapy or drug therapy among dialysis patients with depression. Patients in these studies will be enrolled from among individuals receiving care in 50 dialysis facilities in three metropolitan areas - Seattle, Dallas, and Albuquerque. The research proposal has been developed with the support of patients, caregivers, and stakeholders to ensure that the findings from the study are relevant to them and can be readily implemented in day-to-day clinical practice. Hence, the engagement interview and psychotherapy will be delivered in a dialysis facility to ease the burden on patients, and the dose of the study drug will be changed in partnership with the study participants. In addition to depressive symptoms, the effect of treatment on other meaningful outcomes such as fatigue and sleep will be determined. The two forms of treatment for depression being tested in this clinical trial are very different from each other and patients differ with regards to the treatment option preferable and/or available to them. Successful completion of the clinical trial will provide patients, caregivers, and other stakeholders with the information that they would need when faced with a diagnosis of depression in patients undergoing hemodialysis. This will allow patients to select evidence-based treatments to improve outcomes that are relevant to them.

e-Compared-S: Comparative Effectiveness Research on Internet-based Depression Treatment - Spanish...
Major Depressive DisorderTo compare the clinical and cost-effectiveness of blended Cognitive Behavioural Therapy (CBT) for adults with major depressive disorder (MDD) with treatment as usual (TAU) in Spanish population.