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

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.

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