Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2025-12-25 @ 12:04 AM
NCT ID:
NCT00012558
Eligibility Criteria:
General Inclusion Criteria:
* current age 15 or older (Best Practice Pathway) or 18 years or older (Randomized Care Pathways);
* able to give informed consent for data to be harvested;
* meet DSM-IV criteria for Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS, or Cyclothymic Disorder;
* undergo a complete standard evaluation including clinical interview, self ratings, and laboratory studies;
* meet with Clinical Specialist as scheduled;
* able to complete all Study Registry Forms within 3 months of registration.
General Exclusion Criteria:
* unwilling or unable to adhere to basic study requirements (i.e., complete rating forms, or attend scheduled evaluations);
* not competent to give informed consent in the opinion of the investigator (e.g., psychotic).
Participants will be asked to remain in the study for up to five years so that the investigators can document and evaluate long-term treatment outcome. Participants will meet with their STEP-BD psychiatrist for periodic evaluations and/or treatment adjustments during the course of the study, fill out various self-rating forms, and when applicable, participate in psychotherapy. One of the psychotherapy options, Family-Focused Therapy, will require participants and their families to attend counseling sessions together. Overall, the estimated amount of time required from participants in the study is 2 to 4 hours per month.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Study:
NCT00012558
Study Brief:
Protocol Section:
NCT00012558