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NCT ID: NCT03603561 Recruiting - Depression Clinical Trials

Continuous Theta Burst Stimulation as an add-on Treatment for Bipolar Depression

Start date: August 1, 2018
Phase: N/A
Study type: Interventional

This study aims to investigate the clinical efficacy of continuous theta burst stimulation (cTBS) on the right DLPFC as an add-on treatment in bipolar depression. The study consists of three phases. Phase 1: Bipolar depressed patients will be selected by a certified psychiatrist, who will administer (semi-)structured clinical interviews (M.I.N.I.-Plus 5.0.0, HRSD-17). The presence of exclusion criteria will be evaluated. Eligible patients will undergo MRI brain imaging for TMS neuronavigation Phase 2: Baseline clinical, cognitive and psychomotor assessments will take place. Patients will also undergo blood samples for laboratory and research assessments. TBS involves applying triple-pulse 50 Hz bursts given at a rate of 5 Hz uninterrupted trains (1). Patients will be treated with in total 20 continuous Theta Burst Stimulation (cTBS) session (900 pulses per session) over the right dorsolateral prefrontal cortex, which will be spread over 4 days. A stimulation intensity of 100% of the subject's resting motor threshold (rMT) of the right abductor pollicis brevis muscle will used. Patients will be randomized to receive either the real cTBS or sham treatment. Sham stimulation will be applied with a sham coil. The sham coil produces identical sounds but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS. The investigators expect that real cTBS treatment and not sham will result in a significant and clinical meaningful response. Phase 3: Two post-treatment assessment moments will take place respectively 3 (max. 4) days and 10 (max. 11) days after the last treatment day. The assessments are the same clinical, cognitive and psychomotor assessments as in phase 2.

NCT ID: NCT03601026 Recruiting - Schizophrenia Clinical Trials

Genetic Counselling in the Prevention of Mental Health Consequences of Cannabis Use

IMAGINE
Start date: November 1, 2019
Phase: N/A
Study type: Interventional

Severe mental illness (SMI) refers to the most burdensome psychiatric conditions. The need to pre-empt the onset of SMI is pressing because once SMI develops, quality of life is poor and available treatments have limited efficacy. Most risk factors for SMI are either unchangeable (e.g., genetics) or difficult to alter (e.g., low socio-economic status). In contrast, cannabis use is one specific risk factor that could be avoided. Certain individuals are more vulnerable to the harmful effects of cannabis. Genetic factors can help us identify these high-risk individuals. One in three individuals are carriers of a higher-risk genetic variant, and cannabis users with this genotype are at up to 7-fold increased risk of developing schizophrenia. In our study, genetic counselling will be provided to participants by a board-certified genetic counsellor. During the genetic counselling session, participants will have the option to receive their genotype. Participants will be counselled regarding their individualized risk of developing and of not developing SMI based on family history, whether or not they choose to use cannabis, and genotype (if the participants accept the genetic test results). The investigators hypothesize that this intervention will reduce exposure to cannabis compared to the youth who are not offered the intervention.

NCT ID: NCT03595670 Recruiting - Bipolar Disorder Clinical Trials

Illness Representations in Patients With Bipolar Disorders

RsBiP
Start date: April 11, 2018
Phase:
Study type: Observational [Patient Registry]

Bipolar disorder is a serious and chronic illness representing a major health problem with high mortality rates. According to the self-regulation model , patients had some representations of their illness which are cognitive and emotional. Cognitive representations include the set of beliefs built around the illness, its consequences and treatment. Emotional representations are negative emotions generated by the presence of the illness. According to Leventhal et al. (1997), representations are linked to information extracts by patients from society, relatives, experiences. This model has been particularly studied in the context of somatic disorders, but Baines & Wittkowski (2013) shown that it may also be relevant in patients with mental disorders. In bipolar disorders, first results show that illness representations are related to relapses and to medication adherence. That's why, we think that this relevant to improve knowledges of the psychological processes that accompany the experience of bipolar disorders. To assess illness representation, we will use both qualitative and quantitative tools. These results could have direct application to clinical practice in psychosocial interventions.

NCT ID: NCT03591393 Recruiting - Pregnancy Related Clinical Trials

Pelvic Floor Dysfunction and Its Influence on Body Image and Sexual Function

PFD-BI
Start date: August 1, 2018
Phase: N/A
Study type: Interventional

The first objective to determinate the prevalence of pelvic floor dysfunction in pregnant women and in the first year postpartum. The second objective is to assess the anatomical (both clinical and ultrasound), demographic and obstetric variables in symptomatic women and their association with pelvic floor dysfunction, sexual function and Body Image. This is a single center prospective cohort study. Women will be asked to fill out a questionnaire at the time of their 1st and 3rd trimester scan, at the postpartum checkup and 12 months postpartum. Furthermore, they will undergo a pelvic floor ultrasound at the time of their first and third trimester scan. The presence of pelvic floor dysfunctions will be recorded through validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function. The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire. The anatomy of the pelvic floor will be objectively assessed off line on 3D/4D transperineal ultrasound volumes and POP-Q examination. The demographic variables and information about the pregnancy and the delivery will be obtained from the medical records.

NCT ID: NCT03589079 Recruiting - Genetic Disorder Clinical Trials

Delineation of Novel Monogenic Disorders in the United Arab Emirates Population

Start date: January 1, 2018
Phase:
Study type: Observational

The study aims to identify novel monogenic phenotypes from specific pedigrees and discover the underlying causal genetic variant using genetic sequencing (Sanger and/or Next Generation Sequencing - Panel/WES/WGS) methodologies in families across the United Arab Emirates (UAE).

NCT ID: NCT03579303 Recruiting - Clinical trials for Polycystic Ovary Syndrome

Homoeopathy and Yoga in the Treatment of Menstrual Disorders in Females With Polycystic Ovarian Syndrome

Start date: October 2018
Phase: N/A
Study type: Interventional

This study is undertaken to compare effectiveness of homoeopathic treatment versus integrated approach of homoeopathy and yoga in the treatment of menstrual disorders in females with Polycystic ovarian syndrome.

NCT ID: NCT03564561 Recruiting - Clinical trials for Glycogen Storage Disease Type II, Adult

Natural History of Pompe Disease

POMPE
Start date: June 7, 2019
Phase:
Study type: Observational

The project is a prospective study in which patients affected by adult-onset Pompe disease with c.-32-13T>G mutation in the GAA gene will be followed-up during two years to describe the natural history using clinical, imaging, histological and molecular parameters. Secondary objectives are: - To identify biomarkers for assessing efficacy of future therapies based on correcting aberrant alternative splicing in Pompe patients with c.-32-13T>G mutations. - To determine effectiveness of antisense oligonucleotide chemistries to restore full length GAA transcripts, GAA protein and GAA enzyme activity in fibroblasts and myoblasts obtained from skin and muscle biopsies as well as leucocytes of Pompe patients with c.-32-13T>G mutations.

NCT ID: NCT03564483 Recruiting - Clinical trials for Extramammary Paget Disease

Gynecologic Extramammary Paget's Disease

Start date: February 19, 2018
Phase:
Study type: Observational

In addition to evaluating treatment outcomes, tissue samples and swabs will be collected as part of this study to allow physicians to better understand Extramammary Paget's Disease (EMPD). The researchers also want to learn more about the microorganisms (microbiome) that live on or near the areas of skin affected by EMPD, in order to better understand this condition.

NCT ID: NCT03563755 Recruiting - Clinical trials for Eating Disorders in Adolescence

Social Information Processing in Adolescents With Eating Disorders

Start date: March 28, 2018
Phase: N/A
Study type: Interventional

This research project aims to examine whether adding an online programme of cognitive training exercises may be a helpful addition to treatment as usual for young people with eating disorders. The cognitive training exercises aim to modify distortions in attention and thinking during hypothetical, ambiguous social interactions involving the risk of social rejection. All participants will complete a baseline assessment consisting of a battery of questionnaires and computerised tasks, to assess attention and thinking during ambiguous social interactions involving the risk of social rejection. Participants who display distortions in attention and thinking will then be randomised to one of two groups. In one group participants will receive the computerised training alongside their usual treatment. In the other group participants will continue to receive their treatment as usually only. Healthy controls will also be invited to take part in the baseline assessment to allow for comparisons between clinical and non-clinical groups.

NCT ID: NCT03558256 Recruiting - Clinical trials for Major Depressive Disorder

The Study of Mindfulness-based Cognitive Therapy and Major Depressive Disorder

Start date: May 16, 2016
Phase: N/A
Study type: Interventional

The primary objective of the study is to evaluate the clinical curative effect of mindfulness-based cognitive therapy(MBCT) for major depressive disorder(MDD). Moreover, we will also explore the relationship between P300 potential and erroneous negative potential (ERN) variation and clinical symptoms in MDD and MBCT. This study is a randomized-control trial with two study arms: half of patient cases will receive usual medication treatment with the serotonin reuptake inhibitors (SSRIs) and half of patient cases will receive MBCT added to the usual medication treatment. This study is also a case-control trial, there will be matched normal controls compared with patient cases through a range of psychological scales and electroencephalogram.