Pilot Study of Pharmaceutical and Behavioral Interventions to Treat Anxiety Disorders
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ClinicalTrials.gov Identifier: NCT01631682 |
Recruitment Status :
Completed
First Posted : June 29, 2012
Results First Posted : February 23, 2017
Last Update Posted : February 23, 2017
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Condition or disease | Intervention/treatment | Phase |
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Posttraumatic Stress Disorder Anxiety Disorder | Drug: Propranolol Behavioral: Reactivation Drug: Mifepristone Drug: Intranasal oxytocin | Phase 4 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 186 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Official Title: | Psychophysiology of Delayed Extinction and Reconsolidation in Humans |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | January 2015 |
Actual Study Completion Date : | January 2015 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Propranolol
a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
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Drug: Propranolol
40mg single pill
Other Name: Inderal |
Active Comparator: Reactivation with time delay
For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction
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Behavioral: Reactivation
subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2) |
Experimental: Mifepristone
a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation
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Drug: Mifepristone
1800mg, 9 tablets
Other Names:
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Experimental: Intranasal oxytocin
A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.
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Drug: Intranasal oxytocin
32 IU, 8 self-administered intranasal sprays, 4 in each nostril
Other Name: Syntocinon |
- Change From Baseline Skin Conductance Response [ Time Frame: 48hrs ]Skin conductance response (SCR) is the change in skin conductance level in response to a stimulus. We compared the SCR to a non-treated conditioned stimulus (CS+N) with the SCR to a treated conditioned stimulus (CS+R) by creating a difference score (CS+R - CS+N) for the day 3 data. Day 3 is 48 hours after the fear-conditioning procedure and serves as the primary measure of whether the treatment had an effect. SCR was measured in microSiemens; the SCR difference score reflects a change in microSiemens.

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Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 18-35
- Top half of the normal human distribution of the Spider Phobia Questionnaire-15
Exclusion Criteria:'
- Any criteria for diagnosable spider phobia
- Any current Axis I mental disorder on the Structured Clinical Interview for DSM-IV (SCID)
- Presence of drugs of abuse (e.g. opiates, marijuana, cocaine, or amphetamines) per urine screen
- Non-English speaking (due to lack of validated questionnaires/instruments in other languages)

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): NCT01631682
United States, Massachusetts | |
Massachusetts General Hospital | |
Charlestown, Massachusetts, United States, 02129 |
Principal Investigator: | Scott P. Orr, Ph.D. | Massachusetts General Hospital |
Responsible Party: | Scott Orr, Associate Professor of Psychology, Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT01631682 |
Other Study ID Numbers: |
W81XWH-11-2-0092 |
First Posted: | June 29, 2012 Key Record Dates |
Results First Posted: | February 23, 2017 |
Last Update Posted: | February 23, 2017 |
Last Verified: | January 2017 |
Posttraumatic Stress Disorder PTSD Anxiety |
Fear of spiders Reconsolidation Reconsolidation blockade |
Disease Anxiety Disorders Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Pathologic Processes Mental Disorders Trauma and Stressor Related Disorders Propranolol Oxytocin Mifepristone Oxytocics Reproductive Control Agents Physiological Effects of Drugs Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Arrhythmia Agents Antihypertensive Agents Vasodilator Agents Abortifacient Agents, Steroidal Abortifacient Agents Contraceptives, Oral, Synthetic Contraceptives, Oral Contraceptive Agents, Female Contraceptive Agents Contraceptives, Postcoital, Synthetic Contraceptives, Postcoital Hormone Antagonists |