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NCT ID: NCT01871974 Completed - Clinical trials for Major Depressive Disorder Patients

Study to Evaluate Safety and Tolerability of FK949E in Patients With Major Depressive Disorder

Start date: May 2009
Phase: Phase 1
Study type: Interventional

The objective of the study was to evaluate the safety and plasma concentration changes of quetiapine after multiple oral administration of FK949E (extended-release formulation of quetiapine) in patients with major depressive disorder (MDD).

NCT ID: NCT01870843 Completed - Clinical trials for Depressive Disorder, Major

A Study to Evaluate the Impact of Escitalopram on Quality of Life and Social Functionality in Patients With Major Depressive Disorder With Anxiety Symptom

Start date: March 2014
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the impact of escitalopram on quality of life and social functionality in patients with major depressive disorder with anxiety symptom.

NCT ID: NCT01867398 Terminated - Conduct Disorder Clinical Trials

Effects of Atypical Antipsychotics on Brain Function in Children and Teens With Conduct Disorders

Start date: April 29, 2013
Phase:
Study type: Observational

Background: - Some children and teenagers have conditions known as conduct disorders. They often have long-term chronic behavior problems, such as defiant behavior or violence. Conduct disorders are often treated with antipsychotic medication. Researchers want to study two types of newer antipsychotics (aripiprizole and risperidone) for children and adolescents with conduct disorders. They will look at how these drugs affect brain activity. To do so, they will give brain activity tests using magnetic resonance imaging (MRI). The tests will compare the results from healthy volunteer children and teens to those of others with behavior problems. Objectives: - To see how atypical antipsychotics affect brain activity of children and teenagers with conduct disorders. Eligibility: - Children and teenagers between 10 and 18 years of age who have a conduct disorder and are taking aripiprizole. - Children and teenagers between 10 and 18 years of age who have a conduct disorder and are taking risperidone. - Children and teenagers between 10 and 18 years of age who have a conduct disorder and are not taking an atypical antipsychotic. - Healthy volunteers between 10 and 18 years of age. Design: - Participants will be screened with a physical exam and medical history. Parents/guardians will be asked questions about their child s feelings, experiences, and behavior. Participants will also answer questions about their feelings and moods. - This study will involve two visits. Each visit will involve MRI scanning. - At the first visit, participants will have memory and thinking tests. The tests will involve making decisions or playing games. Some of these tests will use MRI scanning to look at brain activity. - The second visit will be 3 to 5 months after the first visit. The tests from the first visit will be repeated.

NCT ID: NCT01866098 Completed - Schizophrenia Clinical Trials

Naltrexone for Antipsychotic-Induced Weight Gain

NTX
Start date: May 2013
Phase: N/A
Study type: Interventional

This study is designed to look at the effects of naltrexone on weight loss in individuals treated with antipsychotic medications. Naltrexone is an FDA approved medication for the management of alcohol dependence and drug dependence, but has not been fully evaluated for its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how effective two different doses of oral naltrexone is on reducing body weight when compared to placebo (an inactive substance or "sugar pill").

NCT ID: NCT01863628 Recruiting - Bipolar Disorder Clinical Trials

Recognition and Early Intervention on Prodrome in Bipolar Disorders

Start date: March 2013
Phase: N/A
Study type: Interventional

Background and study hypothesis: Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder, lasting for 9-12 years (Egeland et al., 2000). During the prodromal stage, there are three main clusters of syndromes, including hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al., 2008). Of the hypomania/mania symptoms, decreased sleep, elevated mood, irritability, mood lability, increased energy, and psychomotor agitation are present most frequently. The prodromal depressive symptoms are reported to be depressed mood, anhedonia, insomnia, feelings of worthlessness. Among patients with bipolar disorders, 22.5% reported to comorbid with pediatric ADHD. In addition, some symptoms are considered as non-specific such as decreased functioning, anger outburst, social isolation, and anxiety (Egeland et al., 2000). Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents. In a 10-year longitudinal study using 55 prodromal symptoms checklist, , Egeland et al.(2002) found that 38% offspring of parents with bipolar disorder were considered as at risk compared to 17% in children of healthy parents. In a 15-year follow-up study, Duffy et al.,(2009) found that 32.7% offspring (aged 8-25 years old) of parents with bipolar disorder met the criteria of major mood episode. Objectives: One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder. Another primary objective is to conduct a randomized, place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function, with attempt at delaying or preventing the onset of a full-blown bipolar disorder. Design of study and the procedures: The study will consist of two phases: one-week screening period and a randomized, placebo-controlled, 3-month trial. During the screening period, offspring of parents with bipolar disorder will undergo systematically clinical evaluations. The offspring will be evaluated with clinical symptoms assessing scales, neuropsychological tests, magnetic resonance imaging. During the 3-month trial period, the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise, placebo, or wait-list group. Psychiatrists are scheduled to assess mood, treatment outcome during the 3-month trial. Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder aged between 10—25 years, meeting the inclusion of prodromal stage, will be included in the study. All of the offspring will undertake the Kiddie Sads Present and Lifetime Version (K-SADS-PL), and a 70 checklist items of potential prodromal symptoms suggest by us as well as by Dr. Correll et al. (2007). The parents of these offspring are to have a DSM-IV (Diagnostic and Statistical Manual of Mental Disorders)-defined bipolar disorder (bipolar I or II), confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition (SCID-I/P) [First et al., 2002]. The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital. The offspring will be randomly assigned to aerobic exercise and placebo controlled groups. The aerobic exercise would include cycling, jogging,table tennis, and playing badminton for 40 mins at least 3 times a week for 3 months. In each exercise, participants are supposed to exercise to the extent of getting sweaty. In the placebo group, participants will receive general psychoeducation, including delivering knowledge on symptoms, discussion of the suffering mental difficulties, and general coping techniques. Significance: Bipolar disorder is a common, chronic, and recurrent mental disorder. The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder.

NCT ID: NCT01863459 Completed - Clinical trials for Adult Attention Deficit Hyperactivity Disorder (ADHD) With Co-occuring Anxiety and Depressive Disorders

Lisdexamfetamine Dimesylate in the Treatment of Adult ADHD With Anxiety Disorder Comorbidity

Start date: April 2013
Phase: Phase 4
Study type: Interventional

1. To evaluate the safety, and efficacy of Lisdexamfetamine dimesylate in the treatment of outpatients with DSM-IV ADHD with anxiety and depressive disorder comorbidity, as well as to evaluate the effects on quality of life . 2. To evaluate the efficacy of Lisdexamfetamine dimesylate in the treatment of anxiety and depressive disorders which commonly occur with ADHD. 3. To examine the potential relationship between telomere length and Adult ADHD with comorbidity and the potential effect of treatment response. 4. To examine the potential associations with specific genes and Adult ADHD.

NCT ID: NCT01858857 Recruiting - Depression Clinical Trials

Geriatric Psychiatry and Pharmacovigilance

GAP
Start date: May 2013
Phase: N/A
Study type: Observational

The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed. Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system. In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.

NCT ID: NCT01857596 Completed - Clinical trials for Sexual Interest/Arousal Disorder (DSM-5 Defined)

Phase 1b/2a Unblinded Study of Responses in Premenopausal Women With HSDD to Lorexys Evaluating Efficacy and Safety

PURPLE
Start date: April 2013
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to investigate whether Lorexys is effective and safe to treat premenopausal women who have lost their sexual desire to a distressing degree.

NCT ID: NCT01856530 Completed - Clinical trials for Social Anxiety Disorder

Effect of Oxytocin Nasal Sprays on Social Behavior in Social Anxiety Disorder

Start date: July 2012
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to learn more about how the hormone, oxytocin, impacts social behavior in terms of cooperation with others, attention processing, and reward processing, among patients with social anxiety disorder. Based on available research, the investigators predict that in patients with social anxiety disorder, oxytocin will improve social cooperation during an online ball-tossing game called Cyberball, reduce attention toward socially threatening cues during a dot-probe task, and lead to greater willingness to work for monetary rewards for others rather than themselves during an effort expenditure task.

NCT ID: NCT01855074 Completed - Schizophrenia Clinical Trials

An Efficacy and Safety Study of Risperidone Long-Acting Microspheres in Participants With Schizophrenia, Schizophreniform or Schizoaffective Disorders

Start date: November 2007
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of long acting injectable microspheres of risperidone in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self), schizophreniform or schizoaffective disorders (disorders in which there is a loss of ego boundaries or a gross impairment in reality testing with delusions or prominent hallucinations).