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| Sponsor: | National Institute of Mental Health (NIMH) |
|---|---|
| Information provided by: | National Institute of Mental Health (NIMH) |
| ClinicalTrials.gov Identifier: | NCT00930293 |
Purpose
This study will examine the feasibility and efficacy of a personalized psychotherapy treatment for people with depression and co-occurring anxiety.
| Condition | Intervention |
|---|---|
|
Depression Anxiety |
Behavioral: Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS) Behavioral: Brief Supportive Psychotherapy (BSP) Drug: Citalopram hydrobromide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Personalizing Treatment of Depression Complicated by Panic Features-Pilot Study |
| Estimated Enrollment: | 40 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Personalized Depression Care
Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.
|
Behavioral: Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS)
16 weekly IPT-PS sessions, each lasting approximately 45 minutes
Drug: Citalopram hydrobromide
A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Other Name: Celexa
|
|
Active Comparator: Standard Depression Care
Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.
|
Behavioral: Brief Supportive Psychotherapy (BSP)
16 weekly BPS sessions, each lasting approximately 45 minutes
Drug: Citalopram hydrobromide
A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day
Other Name: Celexa
|
Approximately one half of all depressed psychiatric patients also meet the criteria for an anxiety disorder. Compared to people with only depression, people with both depression and panic features experience poorer psychological and social functioning, a greater risk of suicide, less response to medication and therapy treatment, and a greater risk of recurring symptoms. Because people with depression and co-occurring anxiety features do not achieve full symptom remission with either medication or therapy alone, this study will use a treatment that combines the two. A commonly used type of depression medication called a selective serotonin reuptake inhibitor (SSRI) will be combined with a specialized therapy developed to address depression with co-occurring symptoms of panic, anxiety, and avoidance. This study will also test a computer-based method of assessing mood and anxiety symptom profiles and outcomes to determine whether participants find this method acceptable and clinicians find it useful.
Participation in this study will last 20 weeks, with follow-up visits occurring 4 and 8 months after starting. Participants will be randomly assigned to receive either an individualized therapy for depression and anxiety, called interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS), or a standard therapy for depression, called brief supportive psychotherapy (BSP). All participants will complete up to 16 therapy sessions and receive a standard SSRI treatment with the medication citalopram hydrobromide. During the IPT-PS treatment, a study therapist will examine regular computer updates of depression and anxiety scores for participants and talk to them about identifying and addressing life stressors that trigger symptoms. During the BSP treatment, a study therapist will encourage participants to arrive at their own solutions by emphasizing the participants' strengths and examining what has worked in the past.
Participants will complete assessments weekly during the 20 weeks of the study intervention and at 4- and 8-month follow-up visits. These assessments will include self-report questionnaires about symptoms, medication side effects, and treatment adherence; vital sign and weight measurements; and a clinical interview. Regular assessments of medication effectiveness and side effects will occur every 1 to 4 weeks. Starting at the second study visit, participants will also complete monthly computer-based questionnaires about depression and anxiety symptoms.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any of the following medical conditions:
Contacts and Locations| Contact: Tara L. Hofkens | 412-246-5534 | hofkenstl@upmc.edu |
| Contact: Jill M. Cyranowski, PhD | 412-246-5525 | cyranowskijm@upmc.edu |
| United States, Pennsylvania | |
| Western Psychiatric Institute and Clinic | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15218 | |
| Contact: Tara L. Hofkens 412-246-5534 hofkenstl@upmc.edu | |
| Principal Investigator: | Jill M. Cyranowski, PhD | University of Pittsburgh |
More Information
| Responsible Party: | Jill M. Cyranowski, PhD, Associate Professor, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00930293 History of Changes |
| Other Study ID Numbers: | R01 MH085874, MH085874-01, PRO08070009, PCC: DSIR 84-CT |
| Study First Received: | June 26, 2009 |
| Last Updated: | April 30, 2010 |
| Health Authority: | United States: Federal Government |
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Interpersonal Psychotherapy |
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Anxiety Disorders Depression Depressive Disorder Mental Disorders Behavioral Symptoms Mood Disorders Citalopram Dexetimide Antidepressive Agents, Second-Generation Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Serotonin Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Peripheral Nervous System Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |