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Efficacy and Feasibility of a Personalized Treatment for Depression With Co-Occurring Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00930293
First Posted: June 30, 2009
Last Update Posted: February 9, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jill Cyranowski, University of Pittsburgh
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Personalizing Treatment of Depression Complicated by Panic Features-Pilot Study

Resource links provided by NLM:


Further study details as provided by Jill Cyranowski, University of Pittsburgh:

Primary Outcome Measures:
  • Number of Participants Meeting Depression Remission Criteria [ Time Frame: Measured at baseline and weekly for up to 20 weeks of acute treatment ]
    Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, < or = 7


Secondary Outcome Measures:
  • Weeks to Depression Remission [ Time Frame: Measured at baseline and weekly for up to 20 weeks of treatment ]

    Kaplan-Meier survival analyses to determine time to depression remission (defined as average HRSD-17 score < or = 7 for three consecutive weeks).

    Analyses run with the full intent to treat sample (censoring patients who dropped out at time of termination)



Enrollment: 50
Study Start Date: July 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (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 (citalopram) 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 (citalopram) 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

Detailed Description:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently in an episode of nonpsychotic major depression, as defined by the DSM-IV and documented by both the Structured Clinical Interview for Axis I, DSM-IV Disorders (SCID) and by a rating of greater than 15 on the 25-item Hamilton Rating Scale for Depression (HRSD)
  • Panic spectrum risk category of at least 7, as defined by the Panic-Agoraphobic Spectrum Self-Report (PAS-SR), last month version
  • Not currently receiving effective treatment
  • Participants with suicidal ideation are eligible as long as outpatient treatment is deemed safe.

Exclusion Criteria:

  • History of manic or hypomanic episode(s)
  • History of schizophrenia or schizoaffective disorder
  • Mood disorder due to a general medical condition or induced by substance use
  • Presence of psychosis
  • Current pregnancy or plans to become pregnant
  • Current primary diagnosis of anorexia nervosa or bulimia nervosa (this does not include an eating disorder not otherwise specified [NOS])
  • Current primary diagnosis of severe obsessive-compulsive disorder (OCD), as determined by clinician evaluation of symptom severity and temporal onset of symptoms
  • Drug or alcohol abuse or dependence within the past 3 months (participants with episodic abuse related to mood episodes will not be excluded)
  • Satisfies full DSM-IV criteria for antisocial personality disorder, as determined by SCID-II evaluation
  • Requires inpatient treatment because of suicidal risk or psychotic symptoms (current suicidal thinking or parasuicidal behavior is not exclusionary if, in clinician judgment, it can be managed on an outpatient basis)
  • Any of the following medical conditions:

    1. An index episode that is secondary to the effect of medically prescribed drugs, i.e., reserpine, antihistamines, etc.
    2. Presence of significant uncontrolled medical illness including cardiovascular disorder, kidney or liver disease, epilepsy, untreated hypertension, or unstabilized endocrine disease (stable medical conditions such as well-controlled diabetes or HIV positive status are not exclusionary provided the participant meets other inclusion and exclusion criteria)
    3. Current treatment with a pharmacologic, over-the-counter, or herbal therapy for depression or anxiety (unless the participant wishes to discontinue an ineffective treatment)
  • History of poor or failed treatment response to an adequate dose and duration of citalopram
  Contacts and Locations
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): NCT00930293


Locations
United States, Pennsylvania
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Jill M. Cyranowski, PhD University of Pittsburgh
  More Information

Responsible Party: Jill Cyranowski, Associate Professor of Psychiatry and Psychology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00930293     History of Changes
Other Study ID Numbers: R01MH085874 ( U.S. NIH Grant/Contract )
MH085874-01
PRO08070009
PCC: DSIR 84-CT
First Submitted: June 26, 2009
First Posted: June 30, 2009
Results First Submitted: December 19, 2013
Results First Posted: February 9, 2016
Last Update Posted: February 9, 2016
Last Verified: January 2016

Keywords provided by Jill Cyranowski, University of Pittsburgh:
Interpersonal Psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Citalopram
Dexetimide
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
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents