Recognition and Early Intervention on Prodrome in Bipolar Disorders
NCT01863628, Not applicable, Unknown, Guangzhou Psychiatric Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Recognition and Early Intervention on Prodrome in Bipolar Disorders | ClinicalTrials.gov |
| NCT number | NCT01863628 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 120 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Guangzhou Psychiatric Hospital | ClinicalTrials.gov |
| Conditions | Bipolar Disorder | ClinicalTrials.gov |
| Interventions | aerobic exercise, psychoeducation | ClinicalTrials.gov |
| First posted | 2013-05-29 | ClinicalTrials.gov |
| Last updated | 2015-03-17 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change from Baseline in Clinical Global Impressions (CGI) Scale at 12 weeks | Baseline and 12 weeks | Clinical Global Impressions (CGI) Scale is used to assess the patient's global functioning prior to and after initiating a study medication. The CGI provides an overall clinician-determined summary measure, taking into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function | ClinicalTrials.gov |
| Primary | Diagnostic status | baseline and 3 months after treatment | to access whether participants are in the defined prodromal stage of bipolar disorder | ClinicalTrials.gov |
| Secondary | Change from Baseline in Hamilton Depression Rating Scale at 12 weeks | baseline and after 12 weeks | Hamilton Depression Rating Scale is used to assess the depressive symptoms. | ClinicalTrials.gov |
| Secondary | Change from baseline in Young Mania Rating Scale at 12 weeks | baseline and 12 weeks | Young Mania Rating Scale is used to assess hypomania/mania symptoms | ClinicalTrials.gov |
| Secondary | Change from baseline in Brief Psychiatric Rating Scale at 12 weeks | baseline and 12 weeks | Brief Psychiatric Rating Scale is used to assess psychotic symptoms. | ClinicalTrials.gov |
| Secondary | Change from baseline in Hamilton Anxiety Rating Scale at 12 weeks | baseline and 12 weeks | Hamilton Anxiety Rating Scale is used to assess anxious symptoms | ClinicalTrials.gov |
| Secondary | Change from baseline in Global Assessment Scale at 12 weeks | baseline and 12 weeks | Global Assessment Scale is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children | ClinicalTrials.gov |
| Other | Neuropsychological performance | baseline and 12 weeks | Neuropsychological performance is valuated with the MATRICS Consensus Cognitive Battery (MCCB), Test of Nonverbal Intelligence, Third Edition (TONI-3), and STROOP task. The MATRICS Consensus Cognitive Battery (MCCB), developed by the National Institute of Mental Health (NIMH) Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative, has been recommended as the standard battery for clinical trials of cognition-enhancing interventions for schizophrenia as well as bipolar disorders. TONI-3 is used as language free intelligence measure which also helps in the assessment of aptitude, abstract reasoning and problem solving. | ClinicalTrials.gov |
| Other | Functional magnetic resonance imaging | baseline and 12 weeks | Functional magnetic resonance imaging or functional MRI (fMRI) is an magnetic resonance imaging procedure that measures brain activity by detecting associated changes in blood flow. | ClinicalTrials.gov |
| Other | 70 prodromal symptoms checklist for bipolar disorder | baseline | The instrument consists of 70 items assessing different sorts of symptoms, based on the researchers' clinical experiences and the current literature. | ClinicalTrials.gov |
| Other | 70 prodromal symptoms checklist for bipolar disorder | 12 weeks | The instrument consists of 70 items assessing different sorts of symptoms, based on the researchers' clinical experiences and the current literature. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 11
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Other outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)