Darigabat for Panic Disorder
Recruiting in Palo Alto (17 mi)
+27 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Cerevel Therapeutics, LLC
Disqualifiers: Psychiatric comorbidity, Cardiovascular, Neurological, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial is testing if taking darigabat regularly can help people with panic disorder by calming their brain activity to reduce panic attacks.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
What data supports the effectiveness of the drug Darigabat for panic disorder?
There is evidence that treatments affecting the GABA system, like tiagabine, can help with panic disorder, suggesting that Darigabat, which also targets GABA, might be effective.
12345How does the drug Darigabat differ from other treatments for panic disorder?
Darigabat is unique because it targets the GABA system, which is believed to play a role in panic disorder, offering a new approach compared to traditional treatments like moclobemide and clomipramine that focus on different mechanisms.
15678Eligibility Criteria
This trial is for adults with a primary diagnosis of panic disorder, having had at least 8 panic attacks in the past month and no week without panic attacks. They must have a certain body weight and BMI, and not be undergoing any new psychotherapy or have significant psychiatric comorbidities or serious health issues.Inclusion Criteria
I have been diagnosed with panic disorder.
Minimum of 8 panic attacks in the month prior to Screening Visit, with no week free of panic attacks. At least 4 panic attacks in the 2 weeks prior to Baseline Visit, with no week free of panic attacks
PDSS total score ≥12 at Screening and Baseline Visits
+1 more
Exclusion Criteria
I do not have any major heart, lung, stomach, kidney, liver, blood, immune system, or brain diseases.
Current significant psychiatric comorbidity
I have recently started a recognized therapy like CBT.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Titration
Participants receive darigabat or placebo, up to a maximum dose of 12.5 mg, orally, BID for two weeks
2 weeks
Maintenance Treatment
Participants receive darigabat 25 mg or placebo, orally, BID for 12 weeks
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness, safety, and tolerability of darigabat (25 mg twice daily) against a placebo in individuals with panic disorder. Participants will randomly receive either darigabat or placebo to compare outcomes.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DarigabatExperimental Treatment1 Intervention
Participants will receive darigabat, up to a maximum dose of 12.5 mg, orally, BID, for two weeks in the Titration Period and thereafter, 25 mg, orally, BID for 12 weeks in the Maintenance Treatment Period.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive darigabat matching placebo, orally, BID for 2 weeks during the Titration period and thereafter for 12 weeks during the Maintenance Treatment Period.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Draper, UtahDraper, UT
San Jose, CaliforniaSan Jose, CA
North Miami Beach, FloridaNorth Miami Beach, FL
Monroe, North CarolinaMonroe, NC
More Trial Locations
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Who Is Running the Clinical Trial?
Cerevel Therapeutics, LLCLead Sponsor
References
Management of Treatment-Resistant Panic Disorder. [2022]Label="PURPOSE OF REVIEW" NlmCategory="OBJECTIVE"> Purpose of Review Management of treatment-resistant (TR) panic disorder (PD) is an unresolved issue. In this paper, we provide a brief summary of previous findings, an updated (2015-2017) systematic review of pharmacological/non-pharmacological studies, and our personal perspective on this topic.
Panic disorder: efficacy of current treatments. [2009]As has been demonstrated in the numerous studies cited in this report, there are multiple effective treatments for panic disorder (PD), both pharmacological and psychosocial. Available evidence documents that at least 75 percent of patients will have a good response to three classes of medications (tricyclic antidepressants, monoamine oxidase inhibitors, benzodiazepines) which are all approximately equal in efficacy and side effects. Medications may be even more effective when combined with cognitive and behavioral techniques. Several of the psychosocial treatments are also quite effective and appear to have certain advantages, including a low relapse rate. Currently a cognitive treatment specific for panic disorder is under active study and appears especially promising. It is clear that both pharmacological and cognitive-behavioral treatments for panic disorder are effective and can reduce or eliminate the multiple symptoms (panic attacks, phobic avoidance, depression, etc.) and the secondary disability in occupational and social and family roles associated with panic disorder. Untreated, panic disorder patients appear to generally remain chronically ill and worsen over time. What is less clear are issues of length of treatment, outcome after treatment is discontinued, relationship of pharmacological and nonpharmacological treatments, effect of comorbid disorders and presence of subclinical symptoms, and patient characteristics which predict a positive response. The relatively recent finding that panic disorder is a common condition, occurring in about 1-2 percent of the population within any 6-month period (Weissman 1990) has stimulated clinical interest in the development of effective interventions. Until the early 1980s available treatments were generally ineffective, leaving approximately 75 percent of patients unimproved (Doctor 1982). However, excellent pharmacological and nonpharmacological treatments are now available and provide significant improvement with complete resolution of symptoms and disability in the majority of patients. The advances in the knowledge base about panic disorder were underscored in the National Institutes of Health Consensus Development Conference held September 25-27, 1991 at the National Institutes of Health in Bethesda, MD. These conferences are convened periodically by the National Institutes of Health to evaluate available scientific evidence, resolve issues of both safety and treatment efficacy, and make these advances known to the public. One of the primary conclusions from this conference is that "Panic disorder is a distinct condition with a specific presentation, course, and positive family history and for which there are effective pharmacological and cognitive-behavioral treatments" (Panic Consensus Statement 1991).(ABSTRACT TRUNCATED AT 400 WORDS)
The place of selective serotonin reuptake inhibitors in the treatment of panic disorder. [2022]Panic disorder is a frequently chronic condition with extensive patterns of psychiatric comorbidity. Optimum pharmacotherapy with traditional agents is limited by side effects, long-term tolerability, and other problems. Recent research findings support the characterization of panic disorder as an illness involving derangements of central serotonergic function. Selective serotonin reuptake inhibitors could become first-line treatment of the disorder, as they seem to have fewer side effects than tricyclic antidepressants and benzodiazepines.
Management of treatment-refractory panic disorder. [2022]Treatment resistance remains a relatively common problem in panic disorder (PD) despite the success of the selective serotonin reuptake inhibitors (SSRIs) and cognitive behavioral therapy (CBT) as first-line agents. Factors contributing to medication treatment resistance include inadequacy of trial duration, improper dosage, poor tolerability, noncompliance, and medical and psychiatric comorbidity. Poor tolerability to the SSRIs can frequently be addressed by judicious lowering of the initial dose, with a gradual upward titration. For patients who have not responded to one or more adequate trials of SSRIs, options include combination treatment with a benzodiazepine or tricyclic antidepressant (TCA), augmentation with pindolol, or switching to a different class of medication. The newer antidepressants, particularly venlafaxine XR, seem promising as alternatives, and might be beneficial for the refractory patient with a comorbid mood disorder. Anticonvulsants and olanzapine might be particularly beneficial for the refractory patient with hypomania, irritability, and insomnia, who also has demonstrated acute SSRI hypersensitivity. Experimental therapeutics in refractory panic probably will continue to examine the role of corticotropin releasing factor and glutamate/GABA systems. The role of CBT in the medication refractory patient has been explored, with preliminary suggestions of efficacy.
Effects of the GABA-reuptake inhibitor tiagabine on panic and anxiety in patients with panic disorder. [2018]There is evidence that a decreased GABAergic tone plays a role in the pathophysiology of panic disorder (PD). Selective GABAergic treatment has been suggested as a new therapeutic strategy in PD. In this pilot-study anxiolytic effects of the GABA reuptake inhibitor tiagabine (TGB) were investigated in PD.
The efficacy and safety of moclobemide compared to clomipramine in the treatment of panic disorder. [2022]The primary objectives of this multicenter study were to determine the efficacy and safety of moclobemide, a selective reversible inhibitor of monoamino oxidase A, as drug treatment in DSM-III-R panic disorder with and without agoraphobia. In a comparative double-blind, randomized parallel-group design with fixed-flexible dose moclobemide 450 mg per day was compared to clomipramine 150 mg per day, as that drug was considered standard treatment of panic disorder in Europe. 135 patients were randomized and treated for a period of eight weeks. No other treatment was given. By the end of week 8, 49% of the patients treated with moclobemide and 53% of those treated with clomipramine were seen as treatment responders since they were without panic attacks. 78% of the patients in the moclobemide and 88% in the clomipramine group were considered responders according to clinical global impression of change. No significant differences were found between the two treatments at week 8. Adverse events were observed with significantly higher frequency among patients treated with clomipramine, particularly due to anticholinergic side effects. Close to 20% of those treated with moclobemide experienced headache, dizziness, nausea, insomnia, or dry mouth, but other adverse effects were infrequent. In conclusion, moclobemide in a dose of 450 mg per day seems to be a good drug alternative for treatment of panic disorder with and without agoraphobia.
Panic disorder: effective treatment options. [2007]Panic disorder is a distressing and debilitating condition with a familial tendency; it may be associated with situational (agoraphobic) avoidance. The diagnosis of panic disorder requires recurrent, unexpected panic attacks and at least one of the following characteristics: persistent concern about having an additional attack (anticipatory anxiety); worry about the implications of an attack or its consequences (e.g., a catastrophic medical or mental consequence) and making a significant change in behavior as a consequence of the attacks. A variety of pharmacologic interventions is available, as are non-pharmacologic cognitive or cognitive-behavioral therapies that have demonstrated safety and efficacy in the treatment of panic disorder. Early detection and thoughtful selection of appropriate first-line interventions can help these patients, who often have been impaired for years, regain their confidence and ability to function in society.
Potential effectiveness and safety of olanzapine in refractory panic disorder. [2022]Panic disorder is a common and disabling psychiatric disorder. Despite treatment advances, refractory panic disorder requires novel interventions. One such pharmacologic intervention with theoretical and case study support includes olanzapine, a thienobenzodiazepine medication currently approved for schizophrenia in the United States. Ten people with refractory DSM-IV diagnosed panic disorder completed an 8-week, open-label, flexible-dose clinical trial. Baseline, in-treatment, and end-of-treatment data for panic attacks, anticipatory anxiety, phobic avoidance, and impairment were collected. Data were analyzed using SPSS software. Refractory panic disorder patients required a wide dose range averaging 12.3 mg/day of olanzapine to significantly improve or ablate panic attacks. On the average, number of attacks decreased from 6.1/week at baseline to 1.1/week at the end of treatment, and anticipatory anxiety from 32% of the day to 8% of the day. At treatment end, 5 of 10 participants (50%) were panic free, 4 (40%) had one attack in the previous week, 1 (10%) had seven attacks in the previous week, and 6 of 10 participants (60%) were anticipatory anxiety free. There were also statistically and clinically significant improvements in impairment over the course of the trial. There were no significant changes in vital signs, emergent side effects, or average weight, although 6 of 10 people did gain weight. Olanzapine is potentially effective and safe in panic disorder. Due to study limitations, further clinical trials are needed to demonstrate effectiveness.