Health Care Guideline:
Major Depression in Specialty Care in Adults

Copyright © 1998 by Institute for Clinical Systems Integration

The information contained in this web site, including the ICSI Health Care Guidelines ("ICSI Guidelines"), is intended primarily for health professionals and the following expert audiences:

• physicians, nurses, and other health care professional and provider organizations;
• health plans, health systems, health care organizations, hospitals and integrated health care delivery systems;
• medical specialty and professional societies.;
• researchers;
• federal, state and local government health care policy makers and specialists; and
• employee benefit managers.

Neither the ICSI Guidelines nor any other information in this web site should be construed as medical advice or medical opinion related to any specific facts or circumstances. If you are not one of the expert audiences listed above you are urged to consult a health care professional regarding your own situation and any specific medical questions you may have. In addition, you should seek assistance from a health care professional in interpreting the materials in this web site and applying the materials in your individual case.

The ICSI Guidelines contained in this web site are designed to assist clinicians by providing an analytical framework for the evaluation and treatment of patients, and are not intended either to replace a clinician's judgment or to establish a protocol for all patients with a particular condition. An ICSI Guideline rarely will establish the only approach to a problem.

The ICSI Guidelines may be downloaded by any individual or organization. Copies of the ICSI Guidelines may be distributed by any organization to the organization's employees but, except as provided below, may not be distributed outside of the organization without the prior written consent of the Institute for Clinical Systems Integration, Inc. If the ICSI Guidelines are downloaded by a legally constituted medical group, they may be used by the medical group in any of the following ways:

• copies may be provided to anyone involved in the medical group's process for developing and implementing clinical guidelines;
• ICSI Guidelines may be adopted or adapted for use within the medical group only, provided, that ICSI receives appropriate attribution on all written or electronic documents; and
• Copies may be provided to patients and the clinicians who manage their care, if ICSI Guidelines are incorporated into the medical group's clinical guideline program.

All other copyright rights in the ICSI Guidelines are reserved by the Institute for Clinical Systems Integration, Inc. The Institute for Clinical Systems Integration, Inc. assumes no liability for any adaptations or revisions or modifications made to the ICSI Guidelines.

Contents

• Work Group Members
• General Description of Guideline Format
• Targeted Population
• Priority Aims for Medical Groups When Using This Guideline
• Clinical Algorithm & Annotations
• Annotation Appendix A-Global Assessment of Functioning Scale (GAF)
• Evidence Grading
• Guideline Development History
• Instructions for Downloading PDF Version of This Guideline

Work Group Members

Work Group Leader
Teresa Rummans, MD, Mayo Clinic

Psychiatry
Larry Berger, MN, HealthSystem Minnesota
Suzanne Harris, MD, HealthPartners
Teresa Rummans, MD, Mayo Clinic

Pharmacy
Jim Roerig, PharmD, HealthPartners

Health Education
Kathy Van Guilder, HealthSystem Minnesota

Social Work
Mary Gearin, MA, LICSW, HealthPartners

Measurement Adisor
Diane Jacobsen, MPH, ICSI

Business Health Care Action Group Representative
Karen Hanauer, Cargill

Facilitator
Katie Conlin, RN, MPH, ICSI

Back to Contents

Targeted Population

This guideline pertains to major depressive episodes in an outpatient setting for adults aged 18 to 65.

Back to Contents

Priority Aims for Medical Groups When Using This Guideline

1. Improve the comprehensive evaluation of major depression.

Possible measures of accomplishing this aim:

a. Percentage of patients with documentation of multi-axial DSM-IV evaluation.

b. Percentage of patients with complete documentation of at least 5 positive DSM-IV symptoms AND at least one of the symptoms is either depressed mood or loss of interest or pleasure.

2. Improve the treatment of major depressive disorder by mental health clinicians.

Possible measures of accomplishing this aim:

a. Percentage of patients with documentation of receiving education about depression.

b. Percentage of patients with documentation of co-morbid diagnosis.

Back to Contents

Clinical Algorithm & Annotations

• Algorithm Annotation List
  Introduction
  1.   Patient Presents with Depressive Symptoms
  2.   Evaluate Psychiatric Symptoms and Co-Morbidities
  3.   Does Patient Fit Criteria for DSM-IV Depression?
  5.   Does Patient Need Emergency Treatment?
  7.   Re-enter
  8.   Is Active Chemical Abuse/Dependency Present?
  9.   Evaluate and Treat for Chemical Dependency
  10. Treat for Current or Most Recent Episode According to Subtypes; Educate About Depression
  11. Is Patient Responding Adequately?
  12. Evaluate Dose, Duration, and Compliance
  13. Maintenance and Continuing Care
  14. Consider Other Strategies
• Discussion and References: Download PDF Version of This Guideline

Introduction

This guideline pertains to all mental health professionals who will be working with patients with major depressive episodes. Mental Health professionals include clinical social workers, psychiatric nurses, psychologists, and psychiatrists. Patients receiving psychotherapy may also be receiving medication from physicians following the primary care depression guideline.

This guideline pertains only to single and recurrent major depressive disorders. It does not necessarily pertain to depression within the context of bipolar disorders, adjustment disorders, medical conditions or others.

Evaluation

It is expected that those clinicians who make the initial diagnosis will evaluate all five axes. Some patients will require further specialized evaluation by those trained to do medical evaluations (M.D.s), psychological testing and assessment (psychologists and other psychometrists), or substance abuse evaluations (chemical dependency counselors, psychologists, and psychiatrists).

Treatment

Because major depression usually requires biologic treatment, physicians or psychiatric nurse specialists are often involved in the treatment plan. Psychotherapists and other professionals often render care as well. If initial treatments are not entirely successful or if complications become evident, additional professionals may be needed in the areas of psychological testing, medical evaluation and treatment, and others.

Back to Contents
Back to Algorithm Annotation List

1. Patient Presents with Depressive Symptoms

Clinicians should consider the diagnosis of depression not only when patients present with one of the nine symptoms of a major depressive episode, but also when they present with unexplained somatic symptoms, irritability, anxiety, frequent unnecessary visits to physicians, headaches, and other symptoms.

Back to Contents
Back to Algorithm Annotation List

2. Evaluate Psychiatric Symptoms and Co-Morbidities

Multiaxial Assessment

This system involves an assessment on each of five axes. Each axis refers to a different domain of information that may help the clinician assess the patient, plan treatment and predict outcome.

Axis I: Clinical Disorders, Other Conditions That May Be a Focus of Clinical Attention

This axis is for listing all diagnoses of mental illness and psychiatric conditions, except for the personality disorders and mental retardation.

Axis II: Personality Disorders, Mental Retardation

This axis is for reporting personality disorders, mental retardation, and prominent maladaptive personality features and defense mechanisms.

Axis III: General Medical Conditions

*If mood disorder is due to a general medical condition then it is out of the guideline.

Current general medical conditions which are or may be potentially relevant to the listed Axis I and II disorders are reported in this axis.

There are no definitive studies which support recommendations for or against routine laboratory or medical screening.

Axis IV: Psychosocial and Environmental Problems

Psychosocial and environmental problems which may affect the diagnosis, treatment and prognosis of Axes I and II are noted here.

When using the Multiaxial Evaluation Report Form, the clinician should identify the relevant categories of psychosocial and environmental problems and indicate the specific factors involved. If a recording form with a checklist of problem categories is not used, the clinician may simply list the specific problems on Axis IV.

Categories of problems to be considered include:

• problems with primary support group
• problems related to the social environment
• educational problems
• occupational problems
• housing problems
• economic problems
• problems with access to health care services
• problems related to interaction with the legal system/crime
• other psychosocial and environmental problems

Axis V: Global Assessment of Functioning

Axis V is for reporting the clinicians judgement of the individual’s overall level of functioning. This information is useful in rating severity, planning treatment, and measuring its impact, as well as in predicting outcome.

See Appendix A for Global Assessment Form scale.

Back to Contents
Back to Algorithm Annotation List

3. Does Patient fit Criteria for DSM-IV Depression?

DSM-IV Criteria for Major Depressive Episode:

A. Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure.

Note: Do not include symptoms that are clearly due to a general medical condition, or mood-congruent delusions or hallucinations.

1. depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feels sad or empty) or observation made by others (e.g., appears tearful).
2. markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day (as indicated by either subjective account or observation made by others)
3. significant weight loss when not dieting or weight gain (e.g., a change of more than 5% of body weight in a month), or decrease or increase in appetite nearly every day
4. insomnia or hypersomnia nearly every day
5. psychomotor agitation or retardation nearly every day (observable by others, not merely subjective feelings of restlessness or being slowed down)
6. fatigue or loss of energy nearly every day
7. feelings of worthlessness or excessive or inappropriate guilt (which may be delusional) nearly every day (not merely self-reproach or guilt about being sick)
8. diminished ability to think or concentrate, or indecisiveness, nearly every day (either by subjective account or as observed by others)
9. recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide

B. The symptoms do not meet criteria for a Mixed Episode.

C. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning.

D. The symptoms are not due to the direct physiological effects of a substance (e.g., a drug of abuse, a medication) or a general medical condition (e.g., hypothyroidism).

 E. The symptoms are not better accounted for by bereavement, i.e., after the loss of a loved one, the symptoms persist for longer than 2 months or are characterized by marked functional impairment, morbid preoccupation with worthlessness, suicidal ideation, psychotic symptoms, or psychomotor retardation.

The assessment of major depressive disorders should include the DSM-IV numerical rating of the disorder with all 5 digits, thus including a severity rating. For example, 296.22 [Major depressive disorder, single episode, moderate severity].

Back to Contents
Back to Algorithm Annotation List

5. Does Patient Need Emergency Treatment?

Many factors go into the decision to hospitalize a depressed patient. Some of the most salient include:

• suicidal thoughts and/or plans which make the clinician uncertain of the patient’s safety
• assaultive or homicidal thoughts and/or plans which make the clinician uncertain about the safety of the patient or others
• inability to care for the self
• psychotic thinking

Assessment of Suicidality

There are no good predictors of suicide. History which the clinician should consider includes, but is not limited to:

• previous history of suicide attempts
• chemical dependency
• personality disorder and/or physical illness
• family history of suicide
• single status
• recent loss by death, divorce or separation
• insomnia
• panic attacks and/or severe psychic anxiety
• diminished concentration
• severe anhedonia
• severe hopelessness
• suicidal ideation

While it is important to inquire about suicidal tendencies and to account for risk factors, research has shown that all attempts to predict suicidal behavior are somewhat unreliable. Nonetheless, the clinician should routinely address concerns about suicide and document this assessment. The presence of one or more of the factors cited above does not, in and of itself, justify hospitalization or emergency treatment. Clinical judgement as to the likelihood of imminent harm to the patient or others is the most important consideration.

Back to Contents
Back to Algorithm Annotation List

7. Re-enter

If depression is attributed solely to chemical dependence, the patient should be reassessed for major depressive disorder once chemical dependency is in remission.

Back to Contents
Back to Algorithm Annotation List

 8. Is Active Chemical Abuse/Dependency Present?

CAGEAID Screen (AID = Alcohol & Illicit Drugs)

Have you ever:

C    felt you ought to cut down on your drinking or drug use?

A    had people annoy you by criticizing your drinking or drug use?

G    felt bad or guilty about your drinking or drug use?

E    had a drink or used drugs first thing in the morning (eye opener) to steady your nerves or get rid of a hangover or to get the day started?

If substance abuse is present or suspected, consider referral for a chemical dependency assessment.

Back to Contents
Back to Algorithm Annotation List

9. Evaluate and Treat for Chemical Dependency

Evaluation and treatment for chemical dependency is beyond the scope of this guideline. A referral may be appropriate.

Back to Contents
Back to Algorithm Annotation List

10. Treat for Current or Most Recent Episode According to Subtypes; Educate About Depression

Treatment of a major depressive episode usually involves the initiation of pharmacotherapy, particularly in the case of moderate and severe episodes. Data do not support the efficacy of one antidepressant or family of antidepressants over another.

For mild to moderate depression, psychotherapy may be elected instead of, or in addition to, pharmacotherapy.

In any case, treatment should involve agreement between the patient and his or her provider (primary care or psychiatry) involved in managing this condition. For recurrent depression, start with the same treatment approach that worked in the previous episode(s) of depression unless prior side effects suggest a different approach.

The following subtypes have treatment implications:

Atypical Major Depressive Disorder

Start with a selective serotonin reuptake inhibitor or a monoamine oxidase inhibitor.

Psychotic Major Depressive Disorder

Combine a neuroleptic (antipsychotic) with an antidepressant, or use electroconvulsive therapy (ECT).

Seasonal Affective Disorder

Light therapy for seasonal affective disorder is effective, but some issues are unresolved: pathophysiology and usage of medication alone or in conjunction with lights. Responders to light therapy are characterized by hypersomnia, afternoon or evening slump, reverse diurnal variation (evenings worse), and carbohydrate craving.

Melancholic Subtype

Biologic therapy (antidepressants or ECT) is indicated. Some data suggests that SSRIs are less effective than other antidepressants, but contradictory data exist.

Catatonic Subtype

Hospitalization is appropriate for these patients.

 Postpartum Depression

Postpartum blues is a mild and transient episode requiring the passage of time and supportive measures, whereas postpartum depression is potentially severe and prolonged, and requires clinical attention. Treatment consists of medication, targeting more frequent obsessional symptoms and supportive therapy. In addition, confusion, disorganization, and psychosis may be present in which case anti-psychotic medicine is indicated.

Additional Treatment Issues:

Antidepressants during pregnancy

Precautions should be taken when treating pregnant patients. No antidepressants administered during pregnancy have been shown to cause birth defects or other complications, yet no studies have proven definitively that antidepressants are safe to administer during pregnancy. The most extensive reviews of outcomes have involved tricyclic antidepressants and fluoxetine; these reviews have not revealed any negative outcomes in the offspring of pregnant mothers taking the medicines.

Education About Depression

Patient education is essential for successful treatment of a Major Depressive Episode. Education objectives include:

1. Provide basic information on the causes, diagnosis, treatment, and management of depression.

2. Empower patients to help manage their illness in conjunction with their clinician.

3. Involve the family in educational efforts unless contraindicated.

Back to Contents
Back to Algorithm Annotation List

11. Is Patient Responding Adequately?

Assessment includes evaluation of symptoms, work or school attendance and productivity and quality of interpersonal interactions. There is no professional consensus on what represents an adequate antidepressant trial or patient response. Two of the most common causes of inadequate response are:

1. Insufficient dosage; and

2. Inadequate duration of treatment.

Back to Contents
Back to Algorithm Annotation List

12. Evaluate Dose, Duration and Compliance

When patients do not respond to initial antidepressant treatment, clinicians should take the following steps:

1. Reevaluate the diagnosis.

2. Evaluate co-morbid diagnoses.

Substance abuse and personality disorders are often overlooked and confounding. Re-evaluate for the presence of medical conditions.

3. Medication Compliance.

Useful strategies are to review compliance (adherence) to the medication regimen with the patient and family and check with the pharmacy about frequency of refills.

 4. Evaluate Dose.

If side effects are tolerable, increase the antidepressant dose. Serum levels of four tricyclic antidepressants are sometimes useful. For nortriptyline, a curvilinear plasma level/therapeutic response relationship exists between 50 and 150 ng/ml. For desipramine, the relationship between serum level and response is linear, with the threshold for therapeutic response being 116 ng/ml (sensitivity 81%, specificity 59%). For imipramine, a linear relationship exists between anti-depressant response and serum levels of desipramine plus imipramine of 175 to 350 ng/ml. The data for amitriptyline are weakest, and indicate a linear relationship at serum levels of amitriptyline plus nortriptyline of 93 to 140 ng/ml (sensitivity 37%, specificity 80%).

Other than for the 4 agents noted above, serum levels are rarely useful for antidepressants, including SSRIs, bupropion, nefazodone, venlafaxine, mirtazaphine and other tricyclics, unless one is checking for compliance.

5. Consider a longer medication trial.

Duration

Although there is limited scientific data to guide the clinician, an adequate trial of an antidepressant is usually considered to be 4 to 6 weeks. However, duration should not be assessed until the dose is well within the usual therapeutic range, Once that occurs, consider other strategies (see annotation #14) if there is no response or a minimal response after 4 to 6 weeks.

6. Consider consultation with colleagues.

Back to Contents
Back to Algorithm Annotation List

13. Maintenance and Continuing Care

Maintenance Treatment

It is important for the psychotherapist, and the provider prescribing medication to communicate regarding the patient’s treatment plan. Life long maintenance treatment with full dose medicine is considered if three or more episodes of major depression have occurred. Other authors recommend other reasons for maintenance treatment. (Refer to the Discussion and References.)

Back to Contents
Back to Algorithm Annotation List

14. Consider Other Strategies

Augment Therapy

When dosage adjustment is insufficient, augmentation strategies may include:

• Adding lithium to an antidepressant
• Adding triiodothyronine to an antidepressant
• Augmenting SSRI’s with tricyclics, or vice versa. This can be effective but also hazardous. Due to elevation in the serum levels of the tricyclics, this augmentation strategy must be undertaken with caution, and monitoring serums levels may be prudent.

Switch Therapy

If a medication in one family is ineffective, consider changing to a different family of antidepressants. However, failure of a drug in one family does not rule out possible benefit from other drugs in that family. This is particularly true for SSRIs.

Other Biological Therapies

Electroconvulsive treatment is very effective and can sometimes be administered safely in an outpatient setting.

Factors to consider for ECT Use in Major Depression:

1. Antidepressant medications have not been tolerated or pose a significant medical risk.

2. Antidepressant medication trials have not been successful.

3. ECT has been successful in previous episodes.

4. Catatonia is present.

5. A rapid response is needed because of severe suicide risk or because the patient’s health has been significantly compromised by the depression (i.e., severe cachexia, inability to attend to the activities of everyday living).

6. Psychosis is present despite treatment.

Adjunctive light therapy for patients who present with winter onset depression can also be helpful.

Psychotherapies

Randomized, controlled studies of the efficacy of psychotherapy in the treatment of depression are few. However, comprehensive reviews of these studies support the superiority of time-limited, content and procedure-specific therapies such as cognitive-behavioral therapy (CBT), interpersonal therapy (IPT), and marital therapy. Adjunctive psychotherapy for depressions of mild and moderate severity may be useful. Psychotherapies are not as effective as primary treatment for severe depressions. However, supportive therapy, behavioral interventions, education, and involvement of family members can be useful in (although not curative of) severe depression.

Hospitalization

Partial or full hospitalization may be indicated in patients who have failed outpatient management.

Back to Contents
Back to Algorithm Annotation List

Appendix A- Global Assessment of Functioning Scale (GAF)

Consider psychological, social, and occupational functioning on a hypothetical continuum of mental health and illness. Do not include impairment in functioning due to physical (or environmental) limitations.

The rating of overall functioning on a scale of 0—100 was operationalized by Luborsky in the Health-Sickness Rating Scale (Luborsky L: "Clinicians’ Judgments of Mental Health." Archives of General Psychiatry 7:407-417, 1962. Spitzer and colleagues developed a revision of the Health-Sickness Rating Scale called the Global Assessment Scale (GAS) (Endicott J, Spitzer RL, Fleiss JL, Cohen J: "The Global Assessment Scale: A Procedure for Measuring Overall Severity of Psychiatric Disturbance." Archives of General Psychiatry 33:766-771, 1976.) A modified version of the GAS was included in DSMIII-R as the Global Assessment of Functioning (GAF) scale.

The above scale is reproduced from:

Diagnostic and Statistical Manual of Medical Disorders (4th edition). Pg. 32. Washington, D.C.: American Psychiatric Assocation, 1994.

Back to Contents

Evidence Grading

I. CLASSES OF RESEARCH REPORTS

A. Primary Reports of New Data Collection:

Class A: Randomized, controlled trials

Class B: Prospective cohort study
               Case-controlled study nested within a prospective cohort study

Class C: Non-randomized trial with concurrent or historical controls
               Case-control study
               Study of sensitivity and specificity of a diagnostic test
               Population-based descriptive study

Class D: Cross-sectional study
               Case series
               Case report

B. Reports that Synthesize or Reflect upon Collections of Primary Reports:

Class M: Meta-analysis
                 Decision analysis
                 Cost-benefit analysis
                 Cost-effectiveness study

Class R:   Review article
                 Consensus statement
                 Consensus report

Class X:   Medical Opinion

Back to Contents

Guideline Development History

• Document Drafted Oct 1994 - Feb 1995
• Critical Review Period Mar - Apr 1995
• Pilot Implementation Period Aug - Oct 1995
• Revision Approval Nov 1995 - Jan 1996
• General Implementation (First Cycle) Feb - Dec 1996
• Revision/Approval Jan - Mar 1997
• General Implementation (Second Cycle) Apr - Dec 1997
• Revision/Approval Jan - Mar 1998
• General Implementation (Third Cycle) Apr - Dec 1998
• Revision/Approval Jan - Mar 1999
• General Implementation (Fourth Cycle) Begins Apr 1999

Back to Contents

Instructions for Downloading PDF Version of This Guideline

Click here to download the full version of this Guideline in PDF format. You will need ADOBE Acrobat reader to view the file. The reader may be found here.

Back to Contents
Back to List of Guidelines