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

NCT00930293 | Completed Results

• 4 other identifiers: R01MH085874MH085874-01PRO08070009PCC: DSIR 84-CT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the feasibility and efficacy of a personalized psychotherapy treatment for people with depression and co-occurring anxiety.

Conditions

Depression; Anxiety

Keywords

Interpersonal Psychotherapy

Outcome Measures

Primary Outcomes (1)

• Number of Participants Meeting Depression Remission Criteria

  Depression remission defined as 3 consecutive weeks of HRSD-17 scores that on average, \< or = 7

  Measured at baseline and weekly for up to 20 weeks of acute treatment

Secondary Outcomes (1)

• Weeks to Depression Remission

  Measured at baseline and weekly for up to 20 weeks of treatment

Study Arms (2)

Personalized Depression Care

EXPERIMENTAL

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); Drug: Citalopram hydrobromide

Standard Depression Care

ACTIVE COMPARATOR

Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication (citalopram) treatment.

Behavioral: Brief Supportive Psychotherapy (BSP); Drug: Citalopram hydrobromide

Interventions

Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS) BEHAVIORAL

16 weekly IPT-PS sessions, each lasting approximately 45 minutes

Personalized Depression Care

Brief Supportive Psychotherapy (BSP) BEHAVIORAL

16 weekly BPS sessions, each lasting approximately 45 minutes

Standard Depression Care

Citalopram hydrobromide DRUG

A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day

Also known as: Celexa

Personalized Depression Care; Standard Depression Care

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Any of the following medical conditions:
• An index episode that is secondary to the effect of medically prescribed drugs, i.e., reserpine, antihistamines, etc.
• 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

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Interpersonal Psychotherapy; Citalopram

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Propylamines; Amines; Organic Chemicals; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jill M. Cyranowski, PhD
• Organization: University of Pittsburgh

cyranowskijm@upmc.edu

412-246-5588

Study Officials

• Jill M. Cyranowski, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Psychiatry and Psychology

Study Record Dates

• First Submitted: June 26, 2009
• First Posted: June 30, 2009
• Study Start: July 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: February 9, 2016
• Results First Posted: February 9, 2016

Record last verified: 2016-01

Locations

US (1)