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Trial record 54 of 179 for:    "Panic Disorder"

Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine (LTTPANIC)

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ClinicalTrials.gov Identifier: NCT02852577
Recruitment Status : Completed
First Posted : August 2, 2016
Last Update Posted : August 2, 2016
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Rafael Christophe da Rocha Freire, Universidade Federal do Rio de Janeiro

Brief Summary:
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-treatment.

Condition or disease Intervention/treatment Phase
Panic Disorder Agoraphobia Drug: Clonazepam Drug: Paroxetine Phase 4

Detailed Description:

The current study consisted of three steps. The first step was a naturalistic, prospective, randomized, open clinical trial with clonazepam and paroxetine. Subjects received either flexible dose clonazepam (0.5 - 2 mg/day) or paroxetine (10 - 40 mg/day), in monotherapy for eight weeks. In the second step, those who responded to monotherapy in the short-term study continued with the same drug and dose. Partial responders or non-responders were invited to receive combined pharmacological treatment with clonazepam and paroxetine. Patients received the maximum tolerated doses of clonazepam and paroxetine. The doses were flexible, ranging from 0.5 to 2 mg/day for clonazepam and from 10 to 40 mg/day of paroxetine. All patients were treated for 34 months in the second step. Patients who completed the second step and were in remission were included in the third step. For a period of four months all medications were tapered off. These patients were followed for 6 years with evaluations once a year. Those who relapsed were treated on a naturalistic basis, with drugs or psychotherapy.

This study was conducted in accordance with the ethical principles established by the Declaration of Helsinki and the Brazilian National Ethics Committee (Conselho Nacional de Ética em Pesquisa - CONEP) guidelines. The local Ethics Committee approved the study protocol. Written informed consent was obtained from all patients.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term, Open, Naturalistic, Randomized Clinical Trial With Clonazepam and Paroxetine in Panic Disorder With or Without Agoraphobia
Study Start Date : January 2000
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012


Arm Intervention/treatment
Active Comparator: Clonazepam
Treatment with clonazepam
Drug: Clonazepam
Administration of clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 36 months. If no remission after 8 weeks augmentation with paroxetine once a day, flexible dose (10 - 40 mg/day), for 34 months.

Active Comparator: Paroxetine
Treatment with paroxetine
Drug: Paroxetine
Administration of paroxetine once a day, flexible dose (10 - 40 mg/day), for 36 months. If no remission after 8 weeks augmentation with clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 34 months.




Primary Outcome Measures :
  1. Clinical Global Impression Severity scores at 8 weeks [ Time Frame: 8 weeks ]

Secondary Outcome Measures :
  1. Clinical Global Impression Severity scores at 36 months [ Time Frame: 36 months ]
  2. Clinical Global Impression Severity scores at 4 years [ Time Frame: 4 years ]
  3. Clinical Global Impression Severity scores at 9 years [ Time Frame: 9 years ]
  4. Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 8 weeks [ Time Frame: Baseline, 8 weeks ]
  5. Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 36 months [ Time Frame: Baseline, 36 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of panic disorder, with or without agoraphobia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, text revision (DSM-IV-TR) criteria, as determined by a structured clinical interview.
  • At least two panic attacks in the week preceding their inclusion in the study.

Exclusion Criteria:

  • Patients unable or unwilling to provide written informed consent.
  • Did not complete all the evaluations before study initiation.
  • Had comorbidities that could affect clinical evaluation including drug abuse, neurological disorders, or severe personality disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02852577


Locations
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Brazil
Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro
Rio de Janeiro, Brazil, 22290140
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Rafael C Freire, MD, PhD Universidade Federal do Rio de Janeiro

Publications of Results:
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Responsible Party: Rafael Christophe da Rocha Freire, MD, PhD. Assistant professor., Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT02852577     History of Changes
Other Study ID Numbers: 0003.0.249.000-09
First Posted: August 2, 2016    Key Record Dates
Last Update Posted: August 2, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Rafael Christophe da Rocha Freire, Universidade Federal do Rio de Janeiro:
panic disorder
agoraphobia
clonazepam
paroxetine

Additional relevant MeSH terms:
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Panic Disorder
Disease
Agoraphobia
Pathologic Processes
Anxiety Disorders
Mental Disorders
Paroxetine
Clonazepam
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anticonvulsants
GABA Modulators
GABA Agents