Improving Therapeutic Learning in Depression: Proof of Concept

• Status: Completed
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Despite advances in both pharmacotherapy and psychotherapy for major depression, non-response and partial-response remain relatively common outcomes, motivating the search for new treatments. This study is concerned with the development of one such novel treatment, the augmentation of exposure-based cognitive-behavior therapy (CBT) with d-cycloserine (DCS).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boston University; Boston University Charles River Campus
• Treatments: Armodafinil; Cycloserine; Modafinil

Criteria

Inclusion Criteria:

• Must have a DSM diagnosis of major depression as determined by structured diagnostic interview

• Must be free of psychotropic medications other than serotonin selective reuptake inhibitors (SSRIs) for at least 2 weeks

• No current suicidal ideation

• Able to speak and understand English

• Must be between the ages of 18 and 65, inclusive

• Must be a male, or a female who is not of childbearing potential (i.e., surgically sterile, postmenopausal for at least 1 year) or who is non-pregnant, non-lactating and using a medically accepted method of contraception. Acceptable methods of contraception include condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, hormonal contraceptives. A woman of childbearing potential who is not currently sexually active must agree to use a medically accepted method of contraception should she become sexually active while participating in the trial

Exclusion Criteria:

• A DSM diagnosis of dementia, neurodegenerative disease, or other organic mental disorder; substance use disorder other than nicotine or caffeine in the last 3 months; bulimia or anorexia within the last 3 months; lifetime history of psychotic disorder or, bipolar disorder, or developmental disorder;

• A diagnosis of organic brain syndrome, mental retardation, or other cognitive dysfunction that could interfere with a participants capacity to participate in CBT or to complete safety and efficacy assessments

• A history of seizures (apart from childhood febrile seizures) or head trauma causing ongoing cognitive impairment

• An uncontrolled, unstable clinically significant medical condition (e.g., renal, endocrine, hepatic, respiratory, cardiovascular, hematologic, immunologic or cerebrovascular disease, or malignancy, or poorly controlled hypertension (> 150/90mmHg) that may interfere with the interpretation of safety and efficacy evaluations in the opinion of the study physician or investigator

• Medical illness including hypertension, cardiac disease, liver disease, pulmonary diseases, central nervous system disease, and epilepsy;

• Recent (1 year) suicidal attempts or current suicidal ideation

• For women, currently pregnant, plans to be pregnant in the next 2 months, or currently breastfeeding

• Treatment with phenytoin, isoniazid, or propranolol or known sensitivity to modafinil or cycloserine

• A history of head trauma causing loss of consciousness, seizure or ongoing cognitive impairment

• Use of psychotropic medication (including stimulants) other than SSRIs

• Current daily use of alcohol or regular binge alcohol use as determined on the medical screen

• Insufficient command of the English language (i.e., cannot carry on a conversation with an interviewer in the English language or read associated text)

• Receipt of CBT in the previous five years