Treatment Trials

20 Clinical Trials for Various Conditions

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RECRUITING
TMS + Exposure Therapy for Pediatric OCD
Description

The goal of this clinical trial is to compare different forms of transcranial magnetic stimulation (TMS) for improving the outcomes of Exposure with Response Prevention (ERP) in youth and young adults with Obsessive-Compulsive Disorder (OCD). Researchers will compare three groups: ERP with one of two different active ("real") forms of TMS vs. ERP with sham ("fake") TMS. The main questions this study aims to answer are: 1) whether TMS normalizes functioning in brain circuits that contribute to compulsive behavior, and 2) whether TMS reduces compulsions during ERP. Participants will: * Complete clinical interviews, questionnaires, and computerized tasks * Complete two MRIs (brain scans) * Receive daily TMS followed by ERP for two weeks (10 sessions)

RECRUITING
CBT Augmentation to Promote Medication Discontinuation in Pediatric OCD
Description

The purpose of this study is to examine whether youth with OCD who benefit from CBT augmentation to SRI can discontinue their medication without relapse over 24 weeks.

COMPLETED
Overlapping Neural Circuits in Pediatric OCD
Description

The purpose of this study is to examine the brain functioning of children and adolescent with OCD before and after treatment with Exposure and Response Prevention (EXRP) therapy.

COMPLETED
CBT for Pediatric OCD: Community Training Pilot
Description

This study examines a training program for clinicians who work in mental health clinics that serve children with OCD. We will provide clinician training in conducting exposure-based treatments for children with OCD. The purpose of the project is to test the use of a new tool to enhance training in exposure-based treatments for clinicians. Therapists will receive training and oversight from the researchers regarding the treatment procedures and use of the new tool. All children enrolled in the study will receive treatment by clinicians who are participating in this study. Therapists and youth will be recruited separately for the study and will be assigned to work together.

COMPLETED
Novel Medication Strategies Targeting Brain Mechanisms in Pediatric OCD
Description

This study will examine the feasibility and potential efficacy of augmenting SRIs with minocycline. The study will assess whether the addition of minocycline leads to measurable changes in striatal glutamate (Glu) levels. This study will recruit up to 45 youth ages 8-20 diagnosed with clinically significant OCD who have demonstrated no more than minimal response to SRI treatment and are currently on a stable dose of SRI medication for at least 12 weeks. Participants will be randomized to receive either 12 weeks of minocycline treatment or pill placebo. Randomization will be 2:1 so that 2 of 3 participants receive minocycline. Screening for eligibility will take place for 1-4 weeks. Participants will undergo magnetic resonance spectroscopy (MRS) scans to measure striatal Glu levels prior to randomization, and again immediately following the treatment period. During the treatment period, participants will meet initially weekly and then every other week with the study psychiatrist. All participants will be offered three months of open medication treatment following participation. The clinical trial will only be conducted at the New York State Psychiatric Institute (NYSPI) and the MRS scans may be conducted at Weill Cornell Medical Center or NYSPI.

UNKNOWN
The Use of D-Cycloserine to Augment CBT for Pediatric OCD
Description

Pediatric obsessive compulsive disorder (OCD) is a relatively common and often severe condition that can become chronic if untreated. One of the most effective treatments for OCD is a type of cognitive behavioral therapy called exposure and response prevention (ERP). ERP involves presenting a patient with feared objects or situations (the content of their obsessional fears) in a gradual manner while helping them use coping techniques to refrain from engaging in rituals (compulsions). Despite several studies suggesting that ERP is an effective treatment for pediatric OCD, many youngsters fail to respond to this treatment, or respond only partially. An exciting recent finding from animal research is the ability of an established antibiotic (traditionally used to treat Tuberculosis), D-cycloserine (trade name: Seromycin) to enhance certain types of learning among rats. The type of learning that is enhanced is called extinction learning and many researchers believe that extinction learning is the equivalent process to what occurs during ERP; it is the process whereby repeated exposure to the object of fear without any bad outcome causes the object to cease being associated with danger. Several clinical trials using ERP and other forms of exposure treatment for adults with anxiety disorders reproduced this finding from the animal literature; pairing DCS with exposure treatment (comparable to extinction learning) resulted in greater fear reduction than when no DCS was administered. The effects of DCS on exposure treatment for anxiety disorders among children has been tested only preliminarily in one study of children with OCD and results were unclear with children who received DCS augmentation showing non-significant but increased levels of improvement as compared with children who did not receive DCS augmentation. In this study, 26 youngsters ages 7-17 with a primary diagnosis of OCD will be recruited and assigned at random to one of the two treatment conditions. Youth in the DCS condition of the study will receive 50 mg DCS 1 hr prior to each treatment session, while youth in the placebo condition receive an identical placebo capsule 1 hr prior to each treatment augmentation session. All participants will receive 180 minutes of CBT for OCD 4 days per week for 2 weeks during their study participation (as included in IOP already). All families complete a thorough evaluation no more than 5 days prior to receiving DCS on their 9th treatment visit in IOP (third week), and at mid-treatment augmentation (after the 12th IOP treatment session), post-treatment augmentation (after the 16th IOP treatment session), and 3-month follow-up (12 weeks after the 16th IOP treatment session). The primary aim of this study is to obtain preliminary data comparing the effects of the acute administration of DCS versus placebo on symptom response to exposure treatment for pediatric OCD. Results from this study will help to inform and refine future studies, and eventually, impact treatments for pediatric OCD.

COMPLETED
2/2 D-Cycloserine Augmentation of CBT for Pediatric OCD
Description

The purpose of this study is to find out if D-Cycloserine (DCS), taken at the same time as a child gets cognitive behavioral therapy (CBT) can help children with pediatric obsessive-compulsive disorder. Cognitive Behavior Therapy is a talking therapy that will teach children new skills to better cope with his/her OCD. CBT usually uses "exposure-based therapy". This means that the person with OCD slowly learns to deal with things they usually avoid. This is done by moving from less stressful situations to more challenging ones. The investigators hope to enroll about 75 children ages 7-17 years old with OCD in this study at Massachusetts General Hospital (MGH). The National Institute of Mental Health (NIMH) is paying for this study to be done. If your child qualifies for the study, the investigators will assign him or her by chance (like a coin toss) to either the DCS group or the placebo group. You and the study doctor cannot choose your child's study group. Your child will have an equal chance (1 in 2) of being assigned to the DCS group. Your child will be asked to take one or two capsules of the study drug (either DCS or placebo, depending which study group they were assigned to) one hour before CBT visits 4-10. The study coordinator will give your child the study drug at the location of the CBT sessions. This is to make sure that your child takes the study drug one hour before his/her scheduled therapy session. We will ask you to record any bad side effect from the study drug that your child may have before each CBT session. It will take your child about 34 weeks to complete the study. During this time, the investigators will ask you and your child to make a minimum of 17 trips to the study center. There may be up to 23 trips when including CBT Booster sessions. This study uses a placebo. The placebo looks exactly like the DCS, but it contains no DCS. The investigators use placebos in research studies to learn if the the results are caused by the study drug or are due to other reasons. This is a double-blind study. A double-blind study is a study where both the doctor and the study participant do not know whether the study participant is being given DCS or placebo.

TERMINATED
Fluoxetine for Obsessive-Compulsive Disorder in Children and Adolescents With Bipolar Disorder
Description

This will be a 12-week open-label pilot treatment study for children and adolescents (ages 6-17) who meet DSM-IV criteria for bipolar disorder (BPD) and obsessive-compulsive disorder (OCD) who are adequately mood stabilized on a stable regimen based on standard clinical care. Specific hypotheses are as follows: Hypothesis 1: Children and adolescents with comorbid OCD and BPD who have achieved adequate mood stabilization using a naturalistic clinical practice approach, will benefit from an FDA-approved selective seratonin reuptake inhibitor (SSRI) on their OCD symptoms in a clinically meaningful way without exacerbation of bipolar symptoms.

RECRUITING
Transcranial Direct Current Stimulation (tDCS) in Pediatric Obsessive Compulsive Disorder (OCD)
Description

In this study, the investigators aim to understand the role of transcranial direct current stimulation (tDCS) in modulating aberrant neurocognitive processes implicated in pediatric patients with obsessive compulsive disorder (OCD).

TERMINATED
Neuropsychological Profiles of Pediatric Obsessive Compulsive Disorder (OCD)
Description

The neuropsychological profiles of children treated with standard CBT for OCD are evaluated.

COMPLETED
D-cycloserine Augmentation of Cognitive Behavioral Therapy (CBT) for Pediatric Obsessive-compulsive Disorder (OCD)
Description

The investigators are conducting a randomized double-blind placebo-controlled study to assess the efficacy of d-cycloserine augmentation of cognitive-behavioral therapy for the treatment of pediatric obsessive compulsive disorder. This study represents an innovative approach in translating bench research findings into clinical research and testing a new approach for optimizing an effective psychotherapy with a safe non-psychotropic medication.

COMPLETED
Wait-list Study of One-Week Intensive Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder (OCD)
Description

The purpose of this study is to examine how well intensive cognitive-behavioral therapy (CBT) delivered over 5 days works in reducing Obsessive-Compulsive Disorder (OCD) symptoms in children and adolescents. Treatment will consist of exposure and response prevention with an added focus on teaching parents to be exposure coaches.

COMPLETED
Ketamine Treatment for Pediatric-Refractory Obsessive-Compulsive Disorder (OCD)
Description

This pilot study is proposed to determine the acceptability, feasibility and potential efficacy of ketamine, a medication that modulates glutamate in the brain, as a rapid treatment for obsessive-compulsive disorder (OCD) symptoms in adolescents and young adults with OCD. This study will recruit 6 youth (ages 14-22) who are diagnosed with clinically significant OCD and have failed at least one adequate trial of a Serotonin Reuptake Inhibitor (SRI) medication and a course of Cognitive-Behavioral Therapy (CBT) (unless unable to access or tolerate) for OCD in the past. Participants will receive a single infusion of intravenous ketamine and be assessed at regular intervals post-infusion for up to 14 days. At the end of the 14-day treatment phase, all participants will be offered three months of open treatment for OCD with medication and/or CBT.

COMPLETED
N-acetylcysteine (NAC) for Pediatric Obsessive-Compulsive Disorder
Description

Pediatric Obsessive-Compulsive Disorder (OCD) affects 1-3% of children. The investigators currently have effective first-line interventions for pediatric OCD such as Cognitive Behavioral Therapy (CBT) and pharmacotherapy with serotonin reuptake inhibitors (SRIs). However, roughly half of children with OCD still have clinically significant OCD symptoms despite treatment with first-line pharmacological treatments and CBT interventions for OCD. Furthermore, all pharmacological treatments for OCD in children have an increased side effect burden when compared to adults. Novel treatments for children with OCD are needed. N-acetylcysteine (NAC) is a natural supplement that acts as an antioxidant and a glutamate modulating agent. NAC has been used safely for decades in doses 20-40 times higher than in this trial as an antidote for acetaminophen overdose. The only side-effect commonly seen with NAC is nausea and this side-effect is seldom seen in the doses used in this trial. NAC has recently been demonstrated to be effective in a double-blind, placebo-controlled trial in adults with trichotillomania (chronic hair pulling). Trichotillomania is an obsessive-compulsive spectrum disorder that is hypothesized to be closely related to OCD. In other trials NAC has evidence of some efficacy in treating diverse psychiatric conditions such as bipolar depression, schizophrenia and cocaine dependence. The investigators are conducting this trial to determine if NAC is effective in treating OCD.

COMPLETED
Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder
Description

This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment.

COMPLETED
Effectiveness of Sertraline and Cognitive Behavioral Therapy in Treating Pediatric Obsessive-Compulsive Disorder
Description

This study measures the occurrence of certain side effects linked to antidepressant use and evaluates the effectiveness of the medication sertraline plus cognitive behavioral therapy to treat people with obsessive-compulsive disorder.

COMPLETED
Fluoxetine in Pediatric Body Dysmorphic Disorder
Description

This trial will study the effectiveness of the medication fluoxetine for children and adolescents ages 16 and younger with BDD who qualify.

COMPLETED
Family Based Cognitive-Behavioral Treatment for Preschoolers With Obsessive Compulsive Disorder
Description

The purpose of this research study is to further investigate how well cognitive-behavioral psychotherapy works to reduce obsessive-compulsive symptoms in young children with obsessive-compulsive disorder (OCD). Cognitive-behavioral therapy has been shown to work well in youth with OCD and other anxiety disorders; however, there are only a few studies to date in preschool and young children with OCD. All children will have the option to receive 12 twice-weekly cognitive-behavioral psychotherapy sessions that are up to 60-minutes each. Randomly determined, half of all children will receive these sessions immediately following the pre-assessment and the remaining half will receive them after six weeks. The investigators expect that youth receiving the study-based therapy will show more improvement in OCD symptoms in six weeks in contrast to youth waiting to receive the therapy.

RECRUITING
Improving Access to Child Anxiety Treatment
Description

There is strong evidence that cognitive behavioral therapy (CBT) with exposure is the preferred treatment for youth with anxiety disorders, but outpatient services that provide this type of treatment are limited. Even for those who do have access to anxiety-specific treatment, a traditional outpatient model of treatment delivery may not be suitable. Among the numerous logistical barriers to treatment access and response is the inability to generalize treatment tools to settings outside of the office. Patient-centered (home-based or telehealth; patient-centered telehealth closed as of 5/1/21) treatment models that target symptoms in the context in which they occur could be more effective, efficient, and accessible for families. The present study aims to compare the efficacy, efficiency, and feasibility of patient centered home-based CBT and patient centered telehealth CBT with a traditional office-based model of care. The question proposed, including proposed outcomes, have been generated and developed by a group of hospital, payer, patient and family stakeholders who will also contribute to the iterative process of protocol revision. The investigators anticipate 379 anxious youth to be randomized to receive outpatient treatment using telehealth (patient-centered telehealth closed as of 5/1/21), home-based services, or treatment as usual using a traditional outpatient model. Results of this study are expected to provide evidence for the efficacy and efficiency of patient-centered treatment, as well as increase treatment access and family engagement in the treatment process.

COMPLETED
Characterization of Childhood-Onset Obsessive-Compulsive Disorder
Description

The purpose of this study is to learn more about Obsessive-compulsive Disorder (OCD) in children. OCD usually has a slow onset, and symptoms that may remain at a stable level over time. A subset of children with OCD has a sudden onset and symptoms that fluctuate in severity over time. This study will also compare healthy children to those with OCD. This is an observational study; children who participate will not receive any new or experimental therapies. OCD affects nearly 1% of the pediatric population. The symptoms of this illness can interrupt development, causing significant psychological distress and producing life-long impairments in social, academic, and occupational functioning. A subgroup of pediatric OCD has been designated by the acronym PANDAS (Pediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections). This type of OCD is characterized by sudden symptom onset and a relapsing-remitting course of illness; exacerbation of symptoms occurs with scarlet fever or strep. throat infections. This study will identify factors that distinguish children with PANDAS OCD from children with non-PANDAS OCD, and will compare both groups to healthy children. Children with OCD and their parents are screened with interviews and a review of the child's medical records. Participants have an initial evaluation that includes a psychiatric, physical and neuromotor exam, neuropsychological testing, psychological interviews, and a blood test. Structural magnetic resonance imaging (MRS) scans of the brain are also obtained. The MRS scan does not use radiation. After the initial evaluation, children with OCD have follow-up visits every 6 weeks for 12 to 24 months. They are seen yearly for 8 years after the study. If they have a significant improvement or worsening of their symptoms, they are asked to make a maximum of two extra visits. Parents of OCD patients are called four times a year to discuss any changes in the child's condition between yearly visits. All participants have a 1-year follow-up visit upon study completion.