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Therapies for Treatment-Resistant Panic Disorder Symptoms

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00118417
First received: July 6, 2005
Last updated: June 5, 2014
Last verified: June 2014
Results First Received: June 5, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Panic Disorder
Interventions: Drug: Clonazepam
Drug: Sertraline
Behavioral: Cognitive behavioral therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited by advertisement and referral to research at the Center for Anxiety and Traumatic Stress Related Disorders at Massachusetts General Hospital.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
46 participants enrolled, but four participants were lost prior to Phase 1, two due to alcohol abuse and two due to follow-up. Participants were not randomized until the start of Phase 2.

Reporting Groups
  Description
Sertraline / Increased Dose / Medication Optimization In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam
Sertraline / + Placebo / Cognitive Behavior Therapy Augment. In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)

Participant Flow for 3 periods

Period 1:   Phase I (Weeks 0 to 6)
    Sertraline / Increased Dose / Medication Optimization     Sertraline / + Placebo / Cognitive Behavior Therapy Augment.  
STARTED     39     0 [1]
COMPLETED     21     0  
NOT COMPLETED     18     0  
Remission                 8                 0  
Lost to Follow-up                 6                 0  
Loss of Eligibility for Phase 2                 4                 0  
[1] In Phase 1, all participants received open label SSRI - no second treatment arm.

Period 2:   Phase II (Weeks 6 to 12)
    Sertraline / Increased Dose / Medication Optimization     Sertraline / + Placebo / Cognitive Behavior Therapy Augment.  
STARTED     11 [1]   13  
COMPLETED     9     10  
NOT COMPLETED     2     3  
Withdrawal by Subject                 1                 1  
Remission                 1                 2  
[1] Three new participants on Phase 1 endpoint doses of SSRIs entered at Phase 2.

Period 3:   Phase III (Weeks 12 to 24)
    Sertraline / Increased Dose / Medication Optimization     Sertraline / + Placebo / Cognitive Behavior Therapy Augment.  
STARTED     9     10  
COMPLETED     8     9  
NOT COMPLETED     1     1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants No text entered.

Baseline Measures
    All Participants  
Number of Participants  
[units: participants]
  42  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     42  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  37.7  ± 11.2  
Gender  
[units: participants]
 
Female     24  
Male     18  
Region of Enrollment  
[units: participants]
 
United States     42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in Panic Disorder Symptoms, Phase 1 (Week 0 - Week 6)   [ Time Frame: Measured at baseline and after Phase 1 (6 weeks) ]

2.  Primary:   Change in Panic Disorder Symptoms, Phase 2 (Week 6 - Week 12)   [ Time Frame: Measured after Phase 1 (Week 6) and Phase 2 (Week 12) ]

3.  Primary:   Change in Panic Disorder Symptoms, Phase 3 (Week 12 - Week 24)   [ Time Frame: Measured after Phase 2 (Week 12) and Phase 3 (Week 24) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Power in Phase 2 limited detection to a large effect size. High drop-out for increased SSRI dose may indicate poor tolerability. Effectiveness of adding an SSRI to initial CBT was unexamined, limiting generalization to community treatment decisions.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Naomi M. Simon, MD
Organization: Massachusetts General Hospital
phone: 617-726-7913
e-mail: nsimon@partners.org


No publications provided by Massachusetts General Hospital

Publications automatically indexed to this study:

Responsible Party: Naomi M. Simon, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00118417     History of Changes
Other Study ID Numbers: K23 MH001831, K23MH001831, DSIR AT-CD
Study First Received: July 6, 2005
Results First Received: June 5, 2009
Last Updated: June 5, 2014
Health Authority: United States: Federal Government