Long Term Treatment of Panic Disorder With Clonazepam or Paroxetine

NCT02852577 | Completed Phase 4

• 1 other identifier: 0003.0.249.000-09
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Panic Disorder; Agoraphobia

Keywords

panic disorder; agoraphobia; clonazepam; paroxetine

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression Severity scores at 8 weeks

  8 weeks

Secondary Outcomes (5)

• Clinical Global Impression Severity scores at 36 months

  36 months

• Clinical Global Impression Severity scores at 4 years

  4 years

• Clinical Global Impression Severity scores at 9 years

  9 years

• Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 8 weeks

  Baseline, 8 weeks

• Change from baseline of Clinical Global Impression Severity (CGI-S) scale scores at 36 months

  Baseline, 36 months

Study Arms (2)

Clonazepam

ACTIVE COMPARATOR

Treatment with clonazepam

Drug: Clonazepam

Paroxetine

ACTIVE COMPARATOR

Treatment with paroxetine

Drug: Paroxetine

Interventions

Clonazepam DRUG

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.

Clonazepam

Paroxetine DRUG

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.

Paroxetine

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Instituto de Psiquiatria da Universidade Federal do Rio de Janeiro

Rio de Janeiro, Rio de Janeiro, 22290140, Brazil

Location

Related Publications (3)

• Nardi AE, Valenca AM, Freire RC, Mochcovitch MD, Amrein R, Sardinha A, Levitan MN, Nascimento I, de-Melo-Neto VL, King AL, de O E Silva AC, Veras AB, Dias GP, Soares-Filho GL, da Costa RT, Mezzasalma MA, de Carvalho MR, de Cerqueira AC, Hallak JE, Crippa JA, Versiani M. Psychopharmacotherapy of panic disorder: 8-week randomized trial with clonazepam and paroxetine. Braz J Med Biol Res. 2011 Apr;44(4):366-73. doi: 10.1590/s0100-879x2011007500020. Epub 2011 Feb 18.

  PMID: 21344132 RESULT

• Nardi AE, Valenca AM, Freire RC, Amrein R, Sardinha A, Levitan MN, Nascimento I, de-Melo-Neto VL, King AL, de O e Silva AC, Veras AB, Dias GP, Soares-Filho GL, da Costa RT, Mezzasalma MA, de Carvalho MR, de Cerqueira AC, Hallak JE, Crippa JA, Versiani M. Randomized, open naturalistic, acute treatment of panic disorder with clonazepam or paroxetine. J Clin Psychopharmacol. 2011 Apr;31(2):259-61. doi: 10.1097/JCP.0b013e318210b4ee. No abstract available.

  PMID: 21364347 RESULT

• Nardi AE, Freire RC, Mochcovitch MD, Amrein R, Levitan MN, King AL, Valenca AM, Veras AB, Paes F, Sardinha A, Nascimento I, de-Melo-Neto VL, Dias GP, E Silva AC, Soares-Filho GL, da Costa RT, Mezzasalma MA, de Carvalho MR, de Cerqueira AC, Hallak JE, Crippa JA, Versiani M. A randomized, naturalistic, parallel-group study for the long-term treatment of panic disorder with clonazepam or paroxetine. J Clin Psychopharmacol. 2012 Feb;32(1):120-6. doi: 10.1097/JCP.0b013e31823fe4bd.

  PMID: 22198456 RESULT

MeSH Terms

Conditions

Panic Disorder; Agoraphobia

Interventions

Clonazepam; Paroxetine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Phobic Disorders

Intervention Hierarchy (Ancestors)

Benzodiazepinones; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Rafael C Freire, MD, PhD

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD. Assistant professor.

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: August 2, 2016
• Study Start: January 1, 2000
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 2, 2016

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)