Advertisement

Topics

Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder

2014-07-23 21:55:15 | BioPortfolio

Summary

Post-Traumatic Stress Disorder (PTSD) is an anxiety disorder that follows exposure to an extremely traumatic stressors. PTSD is associated with serious symptoms. While numerous approaches have been used to treat PTSD, these treatments have several limiting factors. This study will evaluate a combination of the drugs clonazepam and paroxetine for the treatment of PTSD symptoms.

The main goal of treatment in patients with PTSD is to significantly reduce symptom severity and improve functioning. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period before clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response. The proposed study will examine whether combined treatment with a benzodiazepine (clonazepam) and a selective serotonin reuptake inhibitor (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo (an inactive pill) in the treatment of PTSD.

Participants in this study will be randomly assigned to receive either paroxetine plus clonazepam or paroxetine plus a placebo for 12 weeks. Participants will have weekly clinic visits for the first 4 weeks of the study and every other week for the last 8 weeks. Symptoms of PTSD, anxiety, and depression will be evaluated and drug side effects will be noted during the follow-up visits.

Description

Posttraumatic Stress Disorder (PTSD) is an anxiety disorder (DSM IV) (American Psychiatric Association) that follows exposure to an extremely traumatic stressor in which an individual experienced, witnessed, or was confronted with actual or threatened death or serious injury to self or others. The main goal of treatment in patients with PTSD is to significantly reduce symptom severity across reexperiencing, avoidance and hyperarousal symptoms along with improvement in function. While numerous approaches have been used to treat PTSD, these treatments are limited by variable response rates, up to a 6-week lag period prior to the onset of clinical response, and sub-optimal side effect profile, including possible worsening of anxiety and insomnia prior to clinical response.

The proposed double blind study will examine whether combined treatment with a benzodiazepine (clonazepam) and selective serotonin reuptake inhibitor (SSRI) (paroxetine) in patients with PTSD will accelerate the onset of clinical response. A second goal is to evaluate whether the rapid and clinically meaningful benefits are sustained until the end of the study, despite tapering off the benzodiazepine at the midpoint of the study. The safety and tolerability of a combination of paroxetine and clonazepam will be compared to paroxetine and placebo in the treatment of PTSD.

We hypothesize that treatment with a combination of clonazepam and paroxetine will result in a rapid reduction of PTSD symptoms compared to treatment with placebo and paroxetine. We also propose that this accelerated reduction of symptoms will be sustained until the end-point of the study, despite tapering off the benzodiazepine at the midpoint of the study.

Study Design

Primary Purpose: Treatment

Conditions

Post Traumatic Stress Disorder

Intervention

clonazepam and paroxetine

Location

National Institute of Mental Health (NIMH)
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:55:15-0400

Clinical Trials [1635 Associated Clinical Trials listed on BioPortfolio]

Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

The purpose of this study was to determine whether clonazepam and paroxetine are effective in the treatment of panic disorder. Efficacy was evaluated in short-term, long-term and post-trea...

Evaluation of Clonazepam and Paroxetine for Panic Disorder With Depression

The purpose of this study is to examine the safety and effectiveness of the drug combination paroxetine and clonazepam in treating people with panic disorder (PD) and major depression. Th...

Brexpiprazole as an Additional Treatment to Paroxetine or Sertraline in Adult Patients Suffering From Post-traumatic Stress Disorder (PTSD)

To evaluate the efficacy of brexpiprazole as adjunctive treatment to paroxetine or sertraline on PTSD symptoms.

Paroxetine-CR to Treat Post-Traumatic Stress Disorder (PTSD) Symptomatic After Initial Exposure Therapy

Both pharmacotherapeutic and psychosocial interventions have domenstrated efficacy for PTSD. However, although these interventions can be helpful, many patients remain symptomatic despite...

Prazosin vs Paroxetine in Combat Stress-Related Post-Traumatic Stress Disorder (PTSD) Nightmares & Sleep Disturbance

The purposes of this study are: - to evaluate the efficacy and tolerability of the drug prazosin compared to placebo for combat stress-related nightmares, sleep disturbance and ov...

PubMed Articles [15952 Associated PubMed Articles listed on BioPortfolio]

Trait anxiety mediates the effect of stress exposure on post-traumatic stress disorder and depression risk in cardiac surgery patients.

Post-traumatic stress disorder (PTSD) and depression are common after cardiac surgery. Lifetime stress exposure and personality traits may influence the development of these psychiatric conditions.

Best practice intervention for post-traumatic stress disorder among transit workers.

Transportation industry workers are at high risk for exposure to traumatic incidents in the workplace. A considerable number of those exposed to such incidents will develop post-traumatic stress disor...

Telomere length and telomere repeating factors: Cellular markers for post-traumatic stress disorder-like model.

The aim of the present study was to explore the telomere length of peripheral blood leukocytes from a rat model of post-traumatic stress disorder (PTSD), as well as the expression level of telomere-bi...

Post-traumatic Stress Disorder, Bronchodilator Response, and Incident Asthma in World Trade Center Rescue and Recovery Workers.

Post-traumatic stress disorder (PTSD) has been associated with asthma in cross-sectional studies. Whether PTSD leads to clinically significant bronchodilator response (BDR) or new-onset asthma is unkn...

Psychophysiological Investigation of Combat Veterans with Subthreshold Post-traumatic Stress Disorder Symptoms.

Military service members (SMs) with subthreshold combat-related post-traumatic stress disorder (PTSD) symptoms often have clinically significant functional impairment, even though they do not meet ful...

Medical and Biotech [MESH] Definitions

A class of traumatic stress disorders that is characterized by the significant dissociative states seen immediately after overwhelming trauma. By definition it cannot last longer than 1 month, if it persists, a diagnosis of post-traumatic stress disorder (STRESS DISORDERS, POST-TRAUMATIC) is more appropriate.

A class of traumatic stress disorders with symptoms that last more than one month. There are various forms of post-traumatic stress disorder, depending on the time of onset and the duration of these stress symptoms. In the acute form, the duration of the symptoms is between 1 to 3 months. In the chronic form, symptoms last more than 3 months. With delayed onset, symptoms develop more than 6 months after the traumatic event.

Anxiety disorders manifested by the development of characteristic symptoms following a psychologically traumatic event that is outside the normal range of usual human experience. Symptoms include re-experiencing the traumatic event, increased arousal, and numbing of responsiveness to or reduced involvement with the external world. Traumatic stress disorders can be further classified by the time of onset and the duration of these symptoms.

Syndromes which feature DYSKINESIAS as a cardinal manifestation of the disease process. Included in this category are degenerative, hereditary, post-infectious, medication-induced, post-inflammatory, and post-traumatic conditions.

A benzyl-indazole having analgesic, antipyretic, and anti-inflammatory effects. It is used to reduce post-surgical and post-traumatic pain and edema and to promote healing. It is also used topically in treatment of RHEUMATIC DISEASES and INFLAMMATION of the mouth and throat.

More From BioPortfolio on "Clonazepam and Paroxetine for Rapid Treatment of Post-Traumatic Stress Disorder"

Quick Search
Advertisement
 

Relevant Topics

Anxiety Disorders
Anxiety is caused by stress. It is a natural reaction, and is beneficial in helping us deal with tense situations and pressure. It is deterimental when is becomes an excessive, irrational dread of everyday situations. The most common types of anxiety di...

Stress
Stress is caused by your perception of situations around you and then the reaction of your body to them. The automatic stress response to unexpected events is known as 'fight or flight'. Discovered by Walter Cannon in 1932, it is the release of h...

Psychiatry
Psychiatry is the study of mental disorders and their diagnosis, management and prevention.  Conditions include schizophrenia, severe depression and panic disorders among others. There are pharmaceutical treatments as well as other therapies to help...